Special Issue Reprint

Spine Rehabilitation
in 2022 and Beyond

Edited by
Deed E. Harrison, Ibrahim M. Moustafa and Paul A. Oakley

mdpi.com/journal/jcm
Spine Rehabilitation in 2022
and Beyond
Spine Rehabilitation in 2022
and Beyond

Editors
Deed E. Harrison
Ibrahim M. Moustafa
Paul A. Oakley

Basel • Beijing • Wuhan • Barcelona • Belgrade • Novi Sad • Cluj • Manchester

Editors
Deed E. Harrison Ibrahim M. Moustafa Paul A. Oakley
CBP NonProfit, Inc. University of Sharjah York University
Eagle Sharjah Toronto
USA United Arab Emirates Canada

Editorial Office
MDPI
St. Alban-Anlage 66
4052 Basel, Switzerland

This is a reprint of articles from the Special Issue published online in the open access journal
Journal of Clinical Medicine (ISSN 2077-0383) (available at: https://www.mdpi.com/journal/jcm/
special issues/WB57SSGGE8).

For citation purposes, cite each article independently as indicated on the article page online and as
indicated below:

Lastname, A.A.; Lastname, B.B. Article Title. Journal Name Year, Volume Number, Page Range.

ISBN 978-3-0365-8812-4 (Hbk)

ISBN 978-3-0365-8813-1 (PDF)
doi.org/10.3390/books978-3-0365-8813-1

© 2023 by the authors. Articles in this book are Open Access and distributed under the Creative
Commons Attribution (CC BY) license. The book as a whole is distributed by MDPI under the terms
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license.
Contents

About the Editors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix

Deed E. Harrison, Paul A. Oakley and Ibrahim M. Moustafa

Don’t Throw the ‘Bio’ out of the Bio-Psycho-Social Model: Editorial for Spine Rehabilitation in
2022 and Beyond
Reprinted from: J. Clin. Med. 2023, 12, 5602, doi:10.3390/jcm12175602 . . . . . . . . . . . . . . . . 1

Philip A. Arnone, Steven J. Kraus, Derek Farmen, Douglas F. Lightstone, Jason Jaeger and
Christine Theodossis
Examining Clinical Opinion and Experience Regarding Utilization of Plain Radiography of the
Spine: Evidence from Surveying the Chiropractic Profession
Reprinted from: J. Clin. Med. 2023, 12, 2169, doi:10.3390/jcm12062169 . . . . . . . . . . . . . . . . 11

Fabio Zaina, Rosemary Marchese, Sabrina Donzelli, Claudio Cordani, Carmelo Pulici,
Jeb McAviney, et al.
Current Knowledge on the Different Characteristics of Back Pain in Adults with and without
Scoliosis: A Systematic Review
Reprinted from: J. Clin. Med. 2023, 12, 5182, doi:10.3390/jcm12165182 . . . . . . . . . . . . . . . . 37

Fabio Zaina, Irene Ferrario, Antonio Caronni, Stefano Scarano, Sabrina Donzelli and
Stefano Negrini
Measuring Quality of Life in Adults with Scoliosis: A Cross-Sectional Study Comparing SRS-22
and ISYQOL Questionnaires
Reprinted from: J. Clin. Med. 2023, 12, 5071, doi:10.3390/jcm12155071 . . . . . . . . . . . . . . . . 53

Martina Marsiolo, Silvia Careri, Diletta Bandinelli, Renato Maria Toniolo and Angelo
Gabriele Aulisa
Vertebral Rotation in Functional Scoliosis Caused by Limb-Length Inequality: Correlation
between Rotation, Limb Length Inequality, and Obliquity of the Sacral Shelf
Reprinted from: J. Clin. Med. 2023, 12, 5571, doi:10.3390/jcm12175571 . . . . . . . . . . . . . . . . 75

Ibrahim M. Moustafa, Tamer Shousha, Ashokan Arumugam and Deed E. Harrison

Is Thoracic Kyphosis Relevant to Pain, Autonomic Nervous System Function, Disability, and
Cervical Sensorimotor Control in Patients with Chronic Nonspecific Neck Pain?
Reprinted from: J. Clin. Med. 2023, 12, 3707, doi:10.3390/jcm12113707 . . . . . . . . . . . . . . . . 87

Amal Ahbouch, Ibrahim M. Moustafa, Tamer Shousha, Ashokan Arumugam, Paul Oakley
and Deed E. Harrison
An Investigation of the Association between 3D Spinal Alignment and Fibromyalgia
Reprinted from: J. Clin. Med. 2023, 12, 218, doi:10.3390/jcm12010218 . . . . . . . . . . . . . . . . 109

Ibrahim M. Moustafa, Aliaa Attiah Mohamed Diab and Deed E. Harrison

Does Forward Head Posture Influence Somatosensory Evoked Potentials and Somatosensory
Processing in Asymptomatic Young Adults?
Reprinted from: J. Clin. Med. 2023, 12, 3217, doi:10.3390/jcm12093217 . . . . . . . . . . . . . . . . 121

Maryam Kamel, Ibrahim M. Moustafa, Meeyoung Kim, Paul A. Oakley and Deed E. Harrison
Alterations in Cervical Nerve Root Function during Different Sitting Positions in Adults with
and without Forward Head Posture: A Cross-Sectional Study
Reprinted from: J. Clin. Med. 2023, 12, 1780, doi:10.3390/jcm12051780 . . . . . . . . . . . . . . . . 137

v
Aisha Salim Al Suwaidi, Ibrahim M. Moustafa, Meeyoung Kim, Paul A. Oakley and
Deed E. Harrison
A Comparison of Two Forward Head Posture Corrective Approaches in Elderly with Chronic
Non-Specific Neck Pain: A Randomized Controlled Study
Reprinted from: J. Clin. Med. 2023, 12, 542, doi:10.3390/jcm12020542 . . . . . . . . . . . . . . . . 153

Ibrahim M. Moustafa, Aliaa A. Diab and Deed E. Harrison

The Efficacy of Cervical Lordosis Rehabilitation for Nerve Root Function and Pain in Cervical
Spondylotic Radiculopathy: A Randomized Trial with 2-Year Follow-Up
Reprinted from: J. Clin. Med. 2022, 11, 6515, doi:10.3390/jcm11216515 . . . . . . . . . . . . . . . . 173

Ibrahim Moustafa Moustafa, Aliaa Attiah Mohamed Diab and Deed Eric Harrison
Does Improvement towards a Normal Cervical Sagittal Configuration Aid in the Management
of Lumbosacral Radiculopathy: A Randomized Controlled Trial
Reprinted from: J. Clin. Med. 2022, 11, 5768, doi:10.3390/jcm11195768 . . . . . . . . . . . . . . . . 193

Ahmed S. A. Youssef, Ibrahim M. Moustafa, Ahmed M. El Melhat, Xiaolin Huang,

Paul A. Oakley and Deed E. Harrison
Randomized Feasibility Pilot Trial of Adding a New Three-Dimensional Adjustable
Posture-Corrective Orthotic to a Multi-Modal Program for the Treatment of Nonspecific
Neck Pain
Reprinted from: J. Clin. Med. 2022, 11, 7028, doi:10.3390/jcm11237028 . . . . . . . . . . . . . . . . 209

Ibrahim Moustafa Moustafa, Tamer Mohamed Shousha, Lori M. Walton, Veena Raigangar
and Deed E. Harrison
Reduction of Thoracic Hyper-Kyphosis Improves Short and Long Term Outcomes in Patients
with Chronic Nonspecific Neck Pain: A Randomized Controlled Trial
Reprinted from: J. Clin. Med. 2022, 11, 6028, doi:10.3390/jcm11206028 . . . . . . . . . . . . . . . . 229

Bertel Rune Kaale, Tony J. McArthur, Maria H. Barbosa and Michael D. Freeman
Post-Traumatic Atlanto-Axial Instability: A Combined Clinical and Radiological Approach for
the Diagnosis of Pathological Rotational Movement in the Upper Cervical Spine
Reprinted from: J. Clin. Med. 2023, 12, 1469, doi:10.3390/jcm12041469 . . . . . . . . . . . . . . . . 245

Evan A. Katz, Seana B. Katz and Michael D. Freeman

Non-Surgical Management of Upper Cervical Instability via Improved Cervical Lordosis: A
Case Series of Adult Patients
Reprinted from: J. Clin. Med. 2023, 12, 1797, doi:10.3390/jcm12051797 . . . . . . . . . . . . . . . . 253

vi
About the Editors
Deed E. Harrison
Deed E. Harrison, D.C., graduated from Life Chiropractic College West in 1996. Dr. Harrison
has developed and researched original spinal rehabilitation procedures and has lectured thousands
of Chiropractors at nearly 1000 educational conferences around the world. He has authored
(co-authored) approximately 234 peer-reviewed spine-related publications, seven spine textbooks,
and numerous conference proceedings. He is a highly respected chiropractic researcher and authority
in today’s profession. Dr. Harrison is a manuscript reviewer for several top-tier peer-reviewed Spine
journals, including Spine, Journal of Clinical Medicine, PloS One, Clinical Biomechanics, Clinical
Anatomy, Archives of Physical Medicine and Rehabilitation, the European Spine Journal, European
Journal of Physical Medicine and Rehabilitation, BMC Complimentary Alternative Medicine, and
BMC Musculoskeletal Disorders. Dr. Harrison is a Guest Editor for two Special Issues on spine
rehabilitation for the Journal of Clinical Medicine. Additionally, Dr. Harrison is a past member of the
International Society for the Study of the Lumbar Spine (ISSLS), a former International Chiropractors
Association’s (ICA) Nevada State Assembly Representative member, and the acting Chair of the
PCCRP Chiropractic Radiography Guidelines. He formerly held a position on the Chiropractic
Physicians Board of Nevada. Currently, Dr. Harrison is the President/CEO of Chiropractic
BioPhysics® (CBP®) Technique and President of CBP NonProfit, Inc., a spinal research foundation.
Lastly, he directs and owns a large chiropractic rehabilitation and education facility in Eagle, ID,
USA, called the Ideal Spine Health Center.

Ibrahim M. Moustafa
Ibrahim M. Moustafa is an academic and physiotherapy expert with a remarkable career
spanning over a decade. He earned his doctoral degree in physical therapy from Cairo University
in 2009 and has since made significant contributions to the field. In 2014, Dr. Moustafa achieved
the rank of Associate Professor, solidifying his expertise in physiotherapy. In 2022, he reached
the pinnacle of his academic career, earning the title of Full Professor. His dedication to research
and innovation in spinal rehabilitation and the neurophysiological underpinnings of posture
correction has resulted in numerous publications in esteemed international journals and conferences.
Dr. Moustafa’s outstanding achievements have not gone unnoticed. He was honored with the
Mediterranean Regional Research Award and has also received other prestigious regional accolades.
His commitment to advancing the field of physiotherapy is further evidenced by his role as
a dedicated reviewer for several renowned international journals. Dr. Moustafa serves as an
Editorial Board Member for the Journal of Pain Management and Medicine and Austin Spine Journal.
Furthermore, he is Managing Editor for the Bulletin of Faculty of Physical Therapy at Cairo University,
demonstrating his commitment to fostering academic excellence and research. Since 2018, Dr.
Moustafa has been entrusted with the esteemed position of Chairperson of the Physiotherapy
Department at the University of Sharjah, a testament to his leadership and dedication to education.
Dr. Moustafa’s visionary approach to research and his role as the founder and coordinator of the
Neuromusculoskeletal Research Group underscore his enduring commitment to advancing the field
of physiotherapy, making him a respected figure in academia and research.

vii
Paul A. Oakley
Dr. Oakley maintains a busy spine clinic, consults for Chiropractic BioPhysics Non-Profit
(a Spine Research Foundation), and is pursuing his Ph.D. on postural steadiness and spinal
deformity. He has published well over 100 scientific papers, conference abstracts, and book
chapters, and has presented research at numerous scientific conferences, including the International
Society of Biomechanics, the North American Conference on Biomechanics, the International
Chiropractic Pediatric Association, the Association of Chiropractic Colleges, the Canadian Society
of Biomechanics, and the World Federation of Chiropractic. Dr. Oakley is advanced certified and
an instructor for CBP techniques, and he has participated in creating chiropractic guidelines for both
the practice of Chiropractic and the use of X-rays in the profession. He has a B.Sc. in Kinesiology
(Laurentian University, Sudbury, Ontario), an M.Sc. (Queen’s University, Kingston, Ontario), and a
Doctor of Chiropractic degree (Palmer College of Chiropractic, Davenport, Iowa).

viii
Preface
Spinal disorders and disabilities are among the leading causes of work loss, suffering, and
healthcare expenditures throughout the industrialized world. Spine disorders’ psychosocial and
economic impact demands continued research into the most effective preventative and interventional
treatment strategies. In the past two decades, the role that sagittal plane alignment of the
spine and posture has on human performance, health, pain, disability, and disease has been a
primary research focus among spine surgical and rehabilitation specialists. It has been extensively
demonstrated that sagittal plane alignment of the cervical and lumbar spines impacts human health
and well-being. Limits of normality for various sagittal spine alignment parameters have been
documented, providing chiropractors, physical therapists, surgeons, and other spine specialists with
standardized goals to compare patients to in both pre- and post-treatment decision-making strategies.
High-quality evidence points to spine corrective rehabilitative methods offering superior long-term
outcomes for treating patients with various spine disorders. The economic impact, health benefits,
generalized awareness of posture and spine deformities, and newer sagittal spine rehabilitation
treatments demand continued attention from clinicians and researchers alike. These are the purposes
of this collection of publications in this Special Issue.

Deed E. Harrison, Ibrahim M. Moustafa, and Paul A. Oakley

Editors

ix
 Journal of
Clinical Medicine

Editorial
Don’t Throw the ‘Bio’ out of the Bio-Psycho-Social Model:
Editorial for Spine Rehabilitation in 2022 and Beyond
Deed E. Harrison 1, *, Paul A. Oakley 2,3 and Ibrahim M. Moustafa 4,5

1 CBP Nonprofit (a Spine Research Foundation), Eagle, ID 83616, USA

2 Independent Researcher, Newmarket, ON L3Y 8Y8, Canada; [email protected]
3 Kinesiology and Health Science, York University, Toronto, ON M3J 1P3, Canada
4 Neuromusculoskeletal Rehabilitation Research Group, RIMHS–Research Institute of Medical and
Health Sciences, University of Sharjah, Sharjah 27272, United Arab Emirates; [email protected]
5 Department of Physiotherapy, College of Health Sciences, University of Sharjah,
Sharjah 27272, United Arab Emirates
* Correspondence: [email protected] or [email protected]

1. Introduction
Spinal injuries, disorders and disabilities are among the leading causes for work loss,
suffering, and health care expenditures throughout the industrialized world [1–6]. The
psycho-social and economic impact of general and specific spine disorders demands con-
tinued research into the most effective types of preventative and interventional treatment
strategies. Specifically, low-back-pain (LBP)- and neck-pain-related disorders are the 1st
and 4th leading causes of work loss and disability in the world [1–6]. Though billions
are spent annually in experimental, epidemiology, and interventional strategies, precise
treatment regimens aimed towards improving, resolving, and preventing these spinal
disorders are highly varied and have limited and/or only short-term efficacy [1–6]. Thus,
spinal disorders and related disabilities remain a high priority research avenue within the
health sciences; in particular, there is an urgent need to increase the knowledge related to
the manual rehabilitation disciplines [5,6].
Pain and disability with a spinal origin have several proposed psycho-social [1–9]
and biomechanical contributing factors [10,11] which has given rise to the well-known
‘bio-psycho-social’ model of understanding injury mechanisms leading to the develop-
Citation: Harrison, D.E.; Oakley, P.A.;
ment of chronic pain and disabilities. Problematically, in recent decades, many authors
Moustafa, I.M. Don’t Throw the ‘Bio’
have begun to minimize the ‘bio’ (tissue injury, damage, anatomical disorder, etc.) com-
out of the Bio-Psycho-Social Model:
ponent of the problem, thus favoring the ‘psycho-social’ aspects such as catastrophizing,
Editorial for Spine Rehabilitation in
fear/anxiety and avoidance behavior components in the development of chronic pain in
2022 and Beyond. J. Clin. Med. 2023,
the patient [1–9], as some authors are quite adamant that the ‘tissue injury’ component
12, 5602. https://doi.org/
plays a rather limited role [6]. It can be argued, though, that the lack of appreciation
10.3390/jcm12175602
for the tissue component of spine pain/disorders is shortsighted, based on an incomplete
Received: 21 August 2023 review of recent systematic reviews, and based on limitations with early analytical methods,
Accepted: 23 August 2023 whereas today’s technology and more detailed investigations have identified a significant
Published: 28 August 2023 role for the tissue component as contributing to the presence and development of chronic
spine pain and disability [12–15]. Furthermore, proponents of the stronger role that the
‘psycho-social’ part of the equation plays in spine conditions often fail to acknowledge
that recent systematic literature reviews with meta-analysis have identified a clear contro-
Copyright: © 2023 by the authors.
Licensee MDPI, Basel, Switzerland.
versy regarding the quality and true impact that fear-avoidance, pain-catastrophizing (PC),
This article is an open access article
and ‘psycho-social’ model elements play in individuals with chronic musculoskeletal pain
distributed under the terms and
(CMP) disorders [7–9]; for example, the following has been stated: “Despite the very low
conditions of the Creative Commons quality of the available evidence, the general consistency of the findings highlights the potential role
Attribution (CC BY) license (https:// that PC may play in delaying recovery from CMP. Research that uses higher quality study designs
creativecommons.org/licenses/by/ and procedures would allow for more definitive conclusions regarding the impact of PC on pain and
4.0/).

J. Clin. Med. 2023, 12, 5602. https://doi.org/10.3390/jcm12175602 https://www.mdpi.com/journal/jcm

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J. Clin. Med. 2023, 12, 5602

function.” [7]. The current authors of this Editorial offer this perspective for context and
not to dismiss the role that the psycho-social component plays in initiating and developing
chronic spine related disorders.
It is often understood but understated that the ‘bio’ component in the ‘bio-psycho-
social’ model also stands for biomechanics (not just biology) either segmentally or globally
of the whole spine–body system [10,11]. While the mechanical causes of musculo-skeletal
pain are not completely understood, they are thought to be linked to the interconnected
functions of anatomical components (soft and hard tissues) of the spine where injury
and pain can be caused by any incident that alters joint mechanics (kinematics, kinetics,
alignment), tissue integrity, and muscle function via alterations and increases in general
loading and load sharing of the various tissues [10,11]. Of interest, several authors have
attempted to completely dismiss or minimize the role that biomechanics (alignment and
loading) plays in the onset and development of musculoskeletal disorders [16–20]. For
example, in a systematic review, it was concluded that “Evidence from epidemiological studies
does not support an association between sagittal spinal curves and health including spinal pain.”[16].
Complicating the matter, in each of the reviews that proposed a minimization of the role
that biomechanics (alignment and loading) plays in chronic spine disorders [16–20], serious
flaws in the study design and literature reviews were identified [19–24] highlighting the
controversy and confusing the situation further.
Importantly, in the past two decades, the role that biomechanics of the sagittal plane
alignment of the spine and three-dimensional posture has on human performance, health,
pain, disability, and diseases has been a primary research focus among spine surgical and
rehabilitation specialists across the scientific literature [25–37]. It has been quite extensively
demonstrated that sagittal plane alignment and biomechanics of the lumbo-pelvic [25–32],
thoracic hyper-kyphosis [33–35], and cervical [36,37] spines have clear impacts on human
health and well-being, musculoskeletal disorders, and chronic pain disorders. Limits of
normality for a variety of sagittal spine alignment parameters have been documented,
providing chiropractors, physical therapists, surgeons, and other spine specialists with
standardized goals to compare patients to in both pre- and post-treatment decision-making
strategies [25–40]. Furthermore, conservative interventional methods have been developed
and tested for their effects on improving altered sagittal plane alignment and preliminary
and promising results have been found for a multi-modal program including lumbar
extension traction (LET) [38], cervical extension traction (CET) [39], thoracic extension
traction (TET) [40], bracing for thoracic hyper-kyphosis [41], and various specific exercise
regimens for thoracic-kyphosis [41,42]. Problematically, some authors continue to ignore
the evidence for these new types of sagittal plane curve-inducing (LET and CET) and
curve-reducing (TET) traction methods and spinal bracing and their role in improving the
sagittal plane alignment of the spine and improving chronic musculoskeletal disorders [4].

2. Purposes of Special Issue on Spine Rehabilitation

All too familiar are approaches to spine care involving functional rehabilitation pro-
grams including exercises for strength gains, range of motion increases, generalized stretch-
ing and strengthening procedures, massage, and soft tissue manipulation techniques, as
well as physiotherapeutic modalities such as ultrasound and muscle stimulation, etc. An
alternative to the traditional and popular functional approaches is a structural rehabilita-
tion approach. Structural rehabilitation involves some aspects of functional rehabilitation
methods but focuses on unique types of posture and spine correction methods for the
primary purpose to realign and ‘over-correct’ the spine and altered postures [43].
Although spinal bracing and postural exercise techniques have shown preliminary
evidence for providing structural spine and posture realignment [41,42], one evolved
technique that has laid a substantial foundation towards the structural approach to spine
care is the Chiropractic Biophysics® technique group [43]. From the mid-1990s to the
mid-2000s, the Harrison research team performed a series of spine modeling studies of the
sagittal spinal curves (Figure 1) [43]. This has formed the foundational spinal model to

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J. Clin. Med. 2023, 12, 5602

which patient comparison can be made for initial assessment of alignment abnormality
and follow-up assessment to monitor treatment effects. Further, elaborate assessment
and corrective treatment methods are based on the fundamental assessment of posture in
terms of translations and rotations of the separate body segments in relation to each other
(Figures 2 and 3) [43].

Figure 1. This diagram is the CBP® Full spine Normal Model. It documents the proper path of the
spine from a side view. Ideally, the back of your vertebra should align along this mathematical model.
It is composed of specific ellipses as shown in the following regions on the left: • C1-T1: cervical
(neck) • T1-T12: thoracic (rib cage) • T12-S1 lumbar (low back). The ideal spine has near perfect
vertical balance of the upper- and lower-most vertebra for each of these three spinal regions. Each
region has points of inflection—the mathematical term for change in direction from concavity to
convexity with which to compare your six spinal X-rays against. Along the entire spine, each vertebra
has a graphed mathematical point to correspond to. Such a spinal analysis helps determine proper
(or improper) posture and alignment and how much correction may be required.

Beginning in approximately 2010, Moustafa and colleagues (teaming up with Har-

rison and later Oakley) spearheaded the fundamental missing randomized controlled
trials (RCTs) seeking to understand the efficacy and clinical utility of CET and LET
methods [38,39,44,45]. These RCTs demonstrated that patients with cervical, thoracic, and
lumbo-pelvic sagittal plane abnormality-related symptoms receiving spine correction via
CET and LET methods achieved greater long-term health outcomes (pain, disability, mobil-
ity, etc.) versus patients who only received conventional functional based treatments that
do not consistently improve spinal alignment [38,39,44,45]. Though today there are reliable
and predictable means to restore the natural curvatures of the spine and improve sagittal
balance and generalized posture alignment [38–42], the evidence is still preliminary and
there are many areas for further research including the need for randomized trials on TET
methods, an understanding of which sub-groups of populations with spine disorders might

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J. Clin. Med. 2023, 12, 5602

benefit the most, what is the ideal dose–response of treatment frequency and durations
versus outcomes for different patient populations, and many other areas. Furthermore,
more information from better quality case–control designs and cohort populations are
needed to identify what type of effects (if any) that specific spine displacements have
on musculoskeletal function, neurophysiology, and performance; in other words, more
than just pain and disability outcome measures must be looked at and understood for
a comprehensive understanding of the impact that altered spine/posture alignment has
on spine related disorders and in improving human health and well-being. Additionally,
there is a lack of information on non-sagittal spine displacements, and how these spine
and posture displacements impact human health and disease needs to be comprehensively
investigated. Finally, the economic impact, health benefits, and generalized awareness of
full spine displacements and the newer ‘structural rehabilitation’ spine treatment methods
demand continued attention from clinicians and researchers alike; the topics outlined above
are the purposes of this collection of studies.

Figure 2. Translational Components of Abnormal Body Postures. In each region (head, ribcage,
and pelvis), six distinct translation displacements are shown with “engineering” lines. Thus, 18
postural abnormalities as single postures are shown.

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J. Clin. Med. 2023, 12, 5602

Figure 3. Rotational Components of Abnormal Body Postures. In each region (head, ribcage, and
pelvis), six distinct rotation displacements are shown with “engineering” lines. Thus, 18 postural
abnormalities as single postures are shown.

3. Special Issue Main Accepted Articles

At the time of the writing of this Editorial, there were 15 unique manuscripts ac-
cepted for publication in the Special Issue: Spine Rehabilitation in 2022 and Beyond. These
manuscripts include the following categories of articles: a cross-sectional survey compar-
ing two distinct quality of life questionnaires in adults with scoliosis [46]; a retrospective
consecutive cohort investigation examining the relationship of vertebral y-axis rotation of
the lumbar spine in functional scoliosis with leg length inequality to sacral shelf lateral
tilt angles [47]; a profession wide survey of the chiropractic profession regarding spine
radiography utilization examining clinical opinions and experience [48]; a novel clinical
manual method comparing manual palpation and motion vs. diagnostic imaging to de-
termine pathological rotational instability movement of the upper cervical spine [49]; four
case–control investigations seeking to identify any correlations between spine and posture
displacements and patient pain, disability, neurophysiology, and sensory–motor control
variables [50–53]; one case series looking at the relationship between non-surgical sagittal
plane cervical spine correction and the improvement in upper cervical spine rotational insta-
bility [54]; five randomized trials examining the relationship between correction/reduction
of cervical and thoracic posture deformities and spine displacements and improvements of
a variety of clinical outcome measures including pain, disability, neurophysiology, range
of motion, and sensory–motor control measures [55–59]; and, lastly, one systematic liter-
ature review that sought to understand the differences in low back pain and disability
characteristics in adults with and without scoliotic spine deformities [60].
Importantly, each one of these 15 accepted manuscripts offers unique and succinct
relevant data that provide further evidence that the ‘bio’ (biology and biomechanics) compo-
nent of the ‘bio-psycho-social’ model of spine care is extremely important to understanding
patient pain, disability, and dysfunction and to providing enhanced treatment procedures
that improve the outcomes of patient care [46–60]. As such, this Special Issue on spine
rehabilitation provides useful, cutting-edge, relevant information that should prove to

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J. Clin. Med. 2023, 12, 5602

be useful to improve patient care and outcomes in populations suffering from a wide
variety of spine related disorders. We thank all the authors of each of these manuscripts
for their work, dedication, and insights they provided to bring their team’s data together
in an effective scientific manner. We are confident that each of the manuscripts contained
in this collection will be well cited and used by future clinicians from many disciplines
and researchers to treat patients around the globe and to improve upon the information
presented [46–60].

4. Conclusions
Good quality data currently exist and continue to evolve to support the ‘bio’ element
in the biopsychosocial model of chronic pain disorders. This Special Issue, dedicated to
‘spine rehabilitation in 2022’, features highlights of several research avenues taking place,
such as the link between altered posture and physical performance, altered posture and
pathological conditions, as well as the therapeutic improvement in spine alignment and
posture correlating with positive patient outcomes. These lines of research are desperately
needed and, unfortunately, continue to be underrecognized. We believe a tidal wave of
‘bio’ evidence is mounting, and a better of the understanding of the biomechanics in spine
care will lead to more effective treatments. We hope for the biomechanical spine literature
to continue to gain a wider acknowledgement and acceptance by the chronic spine pain
community.

Author Contributions: Conceptualization, I.M.M., P.A.O. and D.E.H.; writing—I.M.M., P.A.O. and
D.E.H. All authors have read and agreed to the published version of the manuscript.
Conflicts of Interest: Dr. Deed Harrison (DEH) lectures to health care providers on rehabilitation
methods and is the CEO of a company which sells products to physicians for patient care to aid in
improvement of postural and spine ailments as described in this manuscript. PAO is a paid consultant
for CBP NonProfit, Inc. IMM declares no conflict of interest.

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48. Arnone, P.A.; Kraus, S.J.; Farmen, D.; Lightstone, D.F.; Jaeger, J.; Theodossis, C. Examining Clinical Opinion and Experience
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55. Suwaidi, A.S.A.; Moustafa, I.M.; Kim, M.; Oakley, P.A.; Harrison, D.E. A Comparison of Two Forward Head Posture Corrective
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Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual
author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to
people or property resulting from any ideas, methods, instructions or products referred to in the content.

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 Journal of
Clinical Medicine

Article
Examining Clinical Opinion and Experience Regarding
Utilization of Plain Radiography of the Spine: Evidence from
Surveying the Chiropractic Profession
Philip A. Arnone 1, *, Steven J. Kraus 2 , Derek Farmen 1 , Douglas F. Lightstone 3 , Jason Jaeger 4
and Christine Theodossis 5

1 The Balanced Body Center, Matthews, NC 28105, USA

2 Biokinemetrics, Inc., Carroll, IA 51401, USA
3 Institute for Spinal Health and Performance, Folsom, CA 95630, USA
4 Community Based Internship Program, Associate Faculty, Southern California University of Health Sciences,
Whittier, CA 90604, USA
5 Chair, Radiology Department, Sherman College of Chiropractic, Boiling Springs, SC 29316, USA
* Correspondence: [email protected]

Abstract: Plain Radiography of the spine (PROTS) is utilized in many forms of healthcare including
the chiropractic profession; however, the literature reflects conflicting opinions regarding utilization
and value. Despite being an essential part of Evidence-Based Practice (EBP), few studies assess
Doctors of Chiropractic (DCs) clinical opinions and experience regarding the utilization of (PROTS) in
practice. In this study, DCs were surveyed regarding utilization of PROTS in practice. The survey was
administered to an estimated 50,000 licensed DCs by email. A total of 4301 surveys were completed,
of which 3641 were United States (US) DCs. The Clinician Opinion and Experience on Chiropractic
Radiography (COECR) scale was designed to analyze survey responses. This valid and reliable
scale demonstrated good internal consistency using confirmatory factor analysis and the Rasch
model. Survey responses show that 73.3% of respondents utilize PROTS in practice and 26.7% refer
patients out for PROTS. Survey responses show that, among US DCs, 91.9% indicate PROTS has value
Citation: Arnone, P.A.; Kraus, S.J.; beyond identification of pathology, 86.7% indicate that PROTS is important regarding biomechanical
Farmen, D.; Lightstone, D.F.; Jaeger,
analysis of the spine, 82.9% indicate that PROTS is vital to practice, 67.4% indicate that PROTS aids in
J.; Theodossis, C. Examining Clinical
measuring outcomes, 98.6% indicate the opinion that PROTS presents very low to no risk to patients,
Opinion and Experience Regarding
and 93.0% indicate that sharing clinical findings from PROTS studies with patients is beneficial to
Utilization of Plain Radiography of
clinical outcomes. The results of the study indicated that based on clinical experience, the majority of
the Spine: Evidence from Surveying
the Chiropractic Profession. J. Clin.
DCs find PROTS to be vital to practice and valuable beyond the identification of red flags.
Med. 2023, 12, 2169. https://doi.org/
10.3390/jcm12062169 Keywords: X-ray utilization; Evidence-Based Practice (EBP); chiropractic practice; clinical opinion;
chiropractic survey; radiographs
Academic Editors: Gen Inoue,
Akinobu Suzuki and Stefano Negrini

Received: 15 December 2022

Revised: 3 March 2023 1. Introduction
Accepted: 7 March 2023
Doctors of Chiropractic (DCs) are portal of entry healthcare providers trained in the
Published: 10 March 2023
diagnosis and management of spinal related conditions, with an emphasis on biomechan-
ical dysfunction, in addition to screening for pathology. Interestingly, an estimated 85%
of chronic low back pain cases are diagnosed as “non-specific low back pain”, not as a
Copyright: © 2023 by the authors. result of injury, but as a result of an unknown cause, typically from spinal biomechani-
Licensee MDPI, Basel, Switzerland. cal dysfunction [1]. DCs offer safe [2–4], non-pharmaceutical, non-surgical approaches
This article is an open access article to musculoskeletal conditions that have been shown to reduce opioid usage [5–8] and
distributed under the terms and decrease surgical intervention [9,10] and disability [11–13] when compared to other thera-
conditions of the Creative Commons pies. Research shows that when a patient sees a DC first after a low back injury, surgical
Attribution (CC BY) license (https:// intervention is reduced to 1.5% compared to 42.7% when initially evaluated by a surgeon
creativecommons.org/licenses/by/ even after considering other important variables [9]. Additionally, chiropractic intervention
4.0/).

J. Clin. Med. 2023, 12, 2169. https://doi.org/10.3390/jcm12062169 https://www.mdpi.com/journal/jcm

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J. Clin. Med. 2023, 12, 2169

has been shown to reduce opioid usage by 56% [8], and a survey taken in 2012 found
“over 96% respondents with spine-related problems who reported the use of chiropractic
manipulation stated that the therapy helped them with their condition” [14]. While there
are many different methodologies utilized within chiropractic to determine care, plain
radiography has a long history of utilization by the profession as a viable tool in assessing
spinal dysfunction [15]. Current chiropractic scope of practice, while varied from state to
state, allows DCs to order, perform, and interpret radiographs for various reasons including
the evaluation of musculoskeletal disorders, red flags, biomechanical analysis and to aid in
patient management [16].
Plain radiography of the spine (PROTS) is utilized in healthcare to help practitioners
identify suspected red flags, is easily accessible, quick, and is valuable in the diagnosis of
various conditions; however, there are limitations [17]. PROTS has limited ability to detect
soft tissue injury, may lead to unnecessary procedures due to incidental findings and only
produces single, flat images that lack detailed views of three-dimensional structures [18].
Despite recognized value, there is debate within the literature regarding red flags [19,20],
pathology, safety [21], and spinal biomechanical analysis [22–27]. These debates have led
to diametrically opposing viewpoints within the chiropractic profession on the risks, ethics
and economics of ionizing radiation exposure, as well as the value PROTS provides in
cases of mechanical spine pain. As a result, there are efforts to alter clinical guidelines
regarding PROTS suggesting plain radiography be limited to only red flags (history of
recent trauma, infection, cancer, failure to respond to treatment, neurological deficits,
chronicity, etc.) [28], as well as guidelines suggesting PROTS should be expanded for the
qualitative and quantitative assessment of the biomechanical components of the spine
in addition to red flags [29]. Currently, individual interpretation and implementation of
clinical research have created diversity in clinical opinions regarding PROTS, leading to
different clinical experiences throughout the chiropractic profession, which to date have
not been explored.
Clinical opinion and experience are important components of Evidenced-Based Prac-
tice (EBP). EBP was implemented with the goal of improving and evaluating patient
care [30] and has rapidly gained acceptance in the developed world [31]. The EBP model
requires the integration of three factors: robust research evidence, clinical expertise, and
patient values [32,33]. A doctor’s clinical opinion, experience, and expertise, including the
knowledge, judgment, and critical reasoning acquired through training and professional
experience, are essential for implementing evidence-based practices [32,33]. Despite ev-
idence supporting chiropractic care for mechanical spine pain, there is limited research
regarding DCs’ clinical opinion and experience regarding the utilization of PROTS, which
may be of value in the management of mechanical spine pain.
A 2020 report regarding US chiropractic practices reviewed six analyses conducted
between 1993–2015, where 3810 US-based DCs were surveyed on whether the practitioner
took radiographs in their office [34]. The report states that 47% of respondents took
radiographs in their office and that 56.2% of their patients were radiographed. The 53% that
did not take radiographs in their office referred 21.9% of their patients out for radiographs.
Additionally, DCs that relied on radiographs were asked the frequency at which they
performed or referred out for radiographs, as well as for repeat or follow-up radiographs
to monitor patient progress or response to care (61.3%); to identify or rule out fracture,
dislocation, and other pathology (94.1%); and to review for the possible presence of spinal
displacements and (or) vertebral subluxation (66.8%). While this 2020 study had a large
sample and included multiple questions regarding use of radiographs in chiropractic
practice, the binary nature of the questions limited respondents’ ability to convey the extent
of their preferences regarding utilization of plain radiography. A 2021 survey suggests that
the DCs’ preference towards use of radiographs correlated with their view on DCs’ role
in healthcare; however, the limited response options and few questions related to PROTS
are insufficient to conclude the comprehensive opinions and experience of DCs use of
PROTS [35]. Another study from 2017 surveyed a select group of 190 members from the

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J. Clin. Med. 2023, 12, 2169

American Chiropractic College of Radiology, known as chiropractic radiologists, and only

had 73 respondents [36]. The study is limited by the small sample size of chiropractors and
possible bias from members belonging to a select organization.
The current study was comprised of a combination of binary and Likert questions
given to practicing DCs. The aim of the study was to examine the chiropractic profession’s
opinions on the utilization of PROTS, based on their experience, in an attempt to provide
the most in-depth evaluation of such opinions to date. As a result, the authors coordinated
with a statistician in the development of the Clinician Opinion & Experience on Chiro-
practic Radiography (COECR) scale. Our hypothesis for the survey, due to recent national
association press releases [28], is that the survey results would be heavily weighted against
the utilization of PROTS and that we would see conflicting responses.

2. Materials and Methods

In creating the survey for this study, the authors intended to be consistent with
EBP and developed a series of 11 questions to adequately reflect the clinical opinion and
experience of the US DCs on the utilization of PROTS in a chiropractic clinical setting.
All procedures performed in this study were in accordance with the ethical standards of
the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
The authors developed 8 revisions of the survey over a period of 6 months with the
goal to design neutral survey questions that represent the clinicians’ decision process
and to minimize bias. The survey included a variety of both Likert and binary response
options that could accurately reflect each DCs’ clinical opinions and experience rather
than solely binary response options. Many aspects of the clinicians’ decision process were
considered during the process, including why practitioners would or would not order
PROTS, what value DCs attribute to PROTS, how to adequately reflect DCs’ clinical opinion
and experience of PROTS as it relates to patient care, and issues related to plain radiography
utilization safety and research.
The first question requested the participant’s name and address. Participants were
notified in the introduction of the survey that their personal information would remain
anonymous; identifying information was only available for the data analyst to ensure that
survey responses were not duplicated since some DCs may have received multiple survey
invitations. The intention to use the response for future publications was clearly indicated.
If participants consented to participate, they proceeded to questions 2 through 11.
Questions 2 through 9 surveyed the participants about reasons that DCs may or may
not order plain radiography and to determine the presence of radiographic equipment
in the office. Additional findings from these questions include determining the level of
agreement to utilization on a graded scale, questions pertaining to how, why, and when
these procedures are valuable, how and if they have value as it relates to the direction and
outcome of patient treatment and care, and to assess the clinical opinions and experience
regarding the level of risk or safety associated with these procedures.
The 11th and last question of the survey was an open-response textbox that allowed
DCs to explain the rationale that guided their respective answers to survey questions and to
provide additional comments on the subject matter. A summary is provided in Appendix D,
but these responses are not included in the analysis of this publication and will be reserved
for future projects.

2.1. Survey Distribution

To gather a broad sample, we aimed to distribute the survey to as many US DCs
as possible using three main data sources. The survey was distributed through email
invitations (Appendix A) on multiple occasions during a period of 18 months between
2019 and 2021. The survey was formatted using SurveyMonkey, a cloud-based software
platform developed to support online survey data collection. Although sampling weights
were not developed, distribution of emails by state was provided from the database source.

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The primary source of survey distribution was through an opt-in email database
purchased from a leading chiropractic magazine publication resulting in email invitations
on two separate occasions to the database, which included 49,747 DCs located throughout
the US. Appendix B shows the distribution numbers and percentages based on the state
of residence.
Next, the survey link was distributed utilizing an opt-in email source from a private
company database. The survey link was distributed to approximately 20,400 US DCs on
two separate occasions. Third, the survey was disseminated to the non-profit organiza-
tion Chiro Congress (formerly known as the Congress of Chiropractic State Associations,
COCSA) email database. Chiro Congress was selected since it is a national organization
that has affiliated state chiropractic associations from nearly all US states. The state associa-
tions affiliated with the Chiro Congress network were invited to send the survey link to
their members. Lastly, survey recipients were encouraged to share the survey with their
colleagues: all survey email invitations stated, “Please send this survey link and encourage
your colleagues to take the survey as well”.
Overall, the survey was emailed to an estimated 50,000 unique email addresses of
licensed DCs. Approximately 5788 DCs opened the survey (an open rate of approximately
3.99–9.20%), of which 4301 DCs completed responses. If a DC submitted a survey response
more than once, only the most recent submission was used in the analysis. Although the
aim of the survey was to collect responses from practicing DCs in the US (n = 3641), some
responses came from Canada (n = 459) and the rest of the world (n = 201). The survey
submissions were widespread across the US, as represented in Appendix C.

2.2. Statistical Analyses

2.2.1. Procedures and Sample
The analysis included all 10 quantitative survey questions (question 11 was qualitative
and omitted from the analysis of the current study). Question 1 (Q1) collected demographic
information; questions 2 (Q2) and 10 (Q10) had 5 response options each and allowed
participants to choose multiple responses. Question 7 (Q7) offered 5 different categorical
responses, limiting the participants to a single-category response. The remaining questions
collected responses on a 5-point Likert-type scale.
To prepare the data for the analyses, variables were re-coded to account for item
structure and to ensure that higher values corresponded to stronger clinical opinions. The
dependent variable, Q7, originally contained 5 response options, but was dichotomously
re-coded. Q2 and Q10 were dummy-coded, turning each response option into a stand-alone
survey item. Dummy coding is a recategorization of discrete variables into a series of
dichotomous items to ensure a linear relationship [37]. Additionally, by re-coding Q2 and
Q10, the overlapping responses were eliminated. The remaining questions were re-coded in
a way that higher values represented higher levels of the variable. Specifics about re-coding
are detailed in the measures section.

2.2.2. Dependent Variable

The utilization of plain radiography in chiropractic practices was assessed by the fol-
lowing survey item: Please select one answer that best describes your use of general spinal
radiography in your practice. (This is NOT regarding advanced imaging such as CT/MRI).
Respondents were provided with 5 response options to indicate use of spinal radiography:
(1) I do NOT take radiographs in my clinic, I refer patients out to another facility (coded
as 0);
(2) I DO have an X-ray machine in my practice, but I still refer patients out to another
facility for the majority of my spinal radiographs (coded as 0);
(3) I have a plain film X-ray system in my practice and use it for the majority of my
radiographs (coded as 1);
(4) I have a DR (digital radiography) digital X-ray system in my practice and use it for
the majority of my radiographs (coded as 1);

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(5) I have a CR (computed radiography) digital X-ray system in my practice and use it
for the majority of my radiographs (coded as 1).

2.2.3. Predictors
Appendix D provides the full list of survey questions that were used as predictors.

2.3. Clinician Opinion & Experience on Chiropractic Radiography (COECR) Scale

Q2.1–Q2.5 and Q10.1–Q10.5 (Table 1) establish a set of items that capture the clinical
opinions of practicing DCs towards using spinal radiology in chiropractic practices. In
an effort to construct a new scale, this study subjected the COECR scale to psychometric
evaluation by investigating internal consistency of the scale, performing confirmatory
factor analysis, and specifying and testing an Item-Response Theory (IRT) model [38–40].

Table 1. List of survey questions and response options.

Q2.1: Radiographic procedures in a

chiropractic office have value beyond 0 = No 1 = Yes
identification of pathology.
Q2.2: Radiographs for biomechanical
0 = No 1 = Yes
analysis have significant value.
Q2.3: I order radiographs only for red flags
0 = No 1 = Yes
or pathology.
Q2.4: Radiographic procedures are vital to
0 = No 1 = Yes
the chiropractic care I provide in my clinic.
Q2.5: I utilize radiographic procedures to
aid in the measurement of 0 = No 1 = Yes
clinical outcomes.
Q3: What is your level of
agreement/disagreement with the
following statement: Based on the
educational training and past clinical
1 = Strongly disagree 2 = Mostly disagree 3 = Neutral 4 = Mostly agree 5 = Strongly Agree
experiences, the Doctor of Chiropractic
should be able to make their own clinical
decision regarding the utilization of spinal
radiographs on their patients?
Q4: The foundation of an Evidence-Based
Practice (EBP) is based on 3 integrated
components: (1) Doctor’s Clinical
Expertise, (2) Patient Preferences/Values,
and (3) Best Research Evidence. When 1 = Strongly disagree 2 = Mostly disagree 3 = Neutral 4 = Mostly agree 5 = Strongly Agree
making the clinical decision to obtain
spinal radiographs of your patient, should
all three EBP components be
equally considered?
Q5: What is your level of
agreement/disagreement with the
following statement: In my clinical
opinion, patient outcomes would benefit 1 = Strongly disagree 2 = Mostly disagree 3 = Neutral 4 = Mostly agree 5 = Strongly Agree
from continued research regarding
appropriate utilization of spinal
radiographs in the practice of chiropractic?
Q6: What is your level of
agreement/disagreement with the
following statement: In the absence of
published chiropractic research evidence,
1 = Strongly disagree 2 = Mostly disagree 3 = Neutral 4 = Mostly agree 5 = Strongly Agree
the doctor’s clinical experience combined
with patient preferences are adequate for
the appropriate recommendation of spinal
radiographs in the practice of chiropractic?
Q8: What level of risk do you believe is
present in your chiropractic practice
affecting your patients’ health, as a result 1 = No risk 2 = Very low risk 3 = Low risk 4 = Moderate Risk 5 = High risk
of X-ray radiation from your utilization
of radiography?
Q7.1: I do not take radiographs in my
clinic. I refer out to another facility.

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Table 1. Cont.

Q9: What is your level of

agreement/disagreement with the
following statement: In my clinical
experience, sharing chiropractic clinical 1 = Strongly disagree 2 = Mostly disagree 3 = Neutral 4 = Mostly agree 5 = Strongly Agree
findings from radiographic studies with
the patient is beneficial to their
clinical outcome?
Q10.1: To determine adjusting technique or
0 = No 1 = Yes
vertebral levels to be adjusted.
Q10.2: Mechanical analysis or obtaining
0 = No 1 = Yes
measurements of spinal alignment.
Q10.3: Future plan modification
0 = No 1 = Yes
and considerations.
Q10.4: Determine spinal complications
such as degenerative changes, anomalies, 0 = No 1 = Yes
or defects.
Q10.5: Investigate red flags (fracture,
0 = No 1 = Yes
neurologic deficits, suspected pathology).

2.4. Analytic Plan

The statistical analysis began with an examination of descriptive statistics and eval-
uating group differences using chi-square tests and t-tests. For categorical variables, per-
centages were reported. For continuous variables, the averages and standard deviations
were described. Subsequently, binary logistic regression with logit link [41] was estimated
and tested using the survey data. Binary logistic regression is a regression model where
the outcome is following a binomial distribution with predictors of any form including
continuous, categorical, or both [42]. Preference was given to binary logistic regression due
to the distribution of the dependent variable (Q7). The descriptive statistics, chi-square tests,
and logistic regression analyses were conducted in Statistical Package for Social Sciences
(SPSS) version 24.0 [43].
To further understand DCs’ utilization of plain radiology, we performed Rasch analysis
on the set of items that capture DCs’ clinician opinion and experience on PROTS. Fitting
the Rasch model [44] to the data, we were able to evaluate the difficulty of endorsing each
item included in the analysis as well as to estimate the relationship of each item with the
underlying latent trait [45]. In this study, the latent trait, denoted by θ, is the clinical opinion
towards DCs’ utilization of plain radiography in chiropractic practice.

2.5. Study 1: Predicting the Use of Plain Radiography of the Spine in Chiropractic Practice
A multiple binary logistic regression was estimated and tested to understand the
relationship between DCs’ utilization of plain radiography of the spine in chiropractic
practice and the rest of the variables included in the survey. Logistic regression can be
considered an approach similar to multiple linear regression (with Gaussian outcome)
except that the dependent variable is binary [46].

2.6. Study 2: COECR Scale Development and Validation

The Cronbach’s coefficient alpha [47] statistics was used to estimate the internal consis-
tency of the COECR Scale. A one-factor CFA model was applied to responses Q2.1–Q-2.5
and Q10.1–Q10.5 in order to ensure the unidimensionality of the scale. Mplus 8.6 [48] was
used to conduct the dimensionality study. To evaluate the statistical fit of the CFA models,
we used likelihood ratio tests [49], chi-square tests, and model fit indices available for latent
variable modeling. Following the recommendation of Hu and Bentler [50], we used the
root-mean-square error of approximation [51], the comparative fit index [52], and normed
fit index [53].

Rasch Model
The goal of this analysis was to evaluate the psychometric properties of the items on
the COECR scale. Item Response Theory [54] was selected as the framework to test the

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psychometric qualities of items. Two important assumptions made for IRT models are
unidimensionality [55] and local independence [56,57]. The assumption of unidimensional-
ity was tested with CFA. To test the assumption of local independence, Q3 statistics were
estimated [58]. The Q3 statistics are pairwise residual correlations after fitting the Rasch
model for every item pair on a scale. Yen [59] provided the guidance for the assessment
of local independence: “The expected value of Q3, when local independence holds, is
approximately −l/(n − l)” (p. 198). The Q3 statistics for COECR ranged from −0.37 to 0.26,
indicating that the assumption of local independence was not violated [59,60]. The Rasch
model was estimated and graphed in R Statistical Software using irtoys and eRm [61]. The
Q3 statistics were estimated using the mirt package [62].

3. Results
3.1. Initial Results
A summary of the overall 4301 survey respondents is provided (see Tables 2 and 3).
Not all respondents responded to every question. While the survey was intended to
focus on US licensed DCs, there were additional respondents from Canada and other
countries. The collected data allowed for statistical analysis of US responses, comparative
analysis between US and non-US DC responses, and comparative analysis between those
respondents with radiographic facilities and those who lack them as described in the
methods section.

Table 2. Summary of binary survey responses (Questions 2, 7, 10).

Predictor %
Q2: Please select all statements that you agree with regarding
spinal radiographs (multiple choices allowed). (n = 4231)
Q2.1: Radiographic procedures in a chiropractic office have value beyond identification of pathology. 91.9
Q2.2: Radiographs for biomechanical analysis have significant value. 86.7
Q2.3: I order radiographs only for red flags or pathology. 16.5
Q2.4: Radiographic procedures are vital to the chiropractic care I provide in my clinic. 82.9
Q2.5: I utilize radiographic procedures to aid in the measurement of clinical outcomes. 67.4
Q7: Please select the one answer that best describes your use of general spinal
radiography in your practice (This is not regarding advanced imaging such as CT/MRI). (n = 4138)
Q7.1: I do not take radiographs in my clinic. I refer out to another facility. 24.7
Q7.2: I do have an X-ray machine in clinic, but I still refer patients out to another facility for the
2.1
majority of my spinal radiographs.
Q7.3: I have a plain film X-ray system in my practice and us it for the majority of my radiographs. 16
Q7.4: I have a DR digital X-ray system in my practice and use it for the majority of my radiographs. 47.7
Q7.5: I have a CR digital X-ray system in my practice and use it for the majority of my radiographs. (CR
9.5
digital requires the cassette to be placed into the image processor to process images)
Q10: Based on your clinical experience, which reasons are valid to obtain
a spinal radiograph in the practice of chiropractic? (choose all that apply): (n = 4106)
Q10.1: To determine adjusting technique or vertebral levels to be adjusted. 72.1
Q10.2: Mechanical analysis or obtaining measurements of spinal alignment. 84.5
Q10.3: Future plan modification and considerations. 81.9
Q10.4: Determine spinal complications such as degenerative changes, anomalies, or defects. 97.1
Q10.5: Investigate red flags (fracture, neurologic deficits, suspected pathology). 98.2

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Table 3. Summary of responses to Likert-type scale items (Questions 3–6, 8, 9).

Mostly
Predictor n Strongly Agree Mostly Agree Neutral Strongly Disagree
Disagree
Q3 4223 92.9 5.3 0.7 0.6 0.5
Q4 4198 43.3 34.4 9.2 7.6 4.6
Q5 4188 60.9 21.4 11.0 4.4 2.3
Q6 4156 56.6 27.5 7.1 5.7 3.1
Q8 (No Risk-High Risk) 4138 0.2 1.1 10.1 61.2 27.4
Q9 4111 79.1 13.9 3.8 2.2 0.9
n = number of respondents per question.

3.2. Descriptive Statistics, Chi-Square, and Mean Differences

A complete case analysis (also known as listwise deletion) for missing data was
performed. Listwise deletion is a method that excludes an entire record from the analysis if
any single value is missing [63]. The analysis revealed 232 cases with missing responses,
which were removed from the dataset. Exclusion of cases with missing data on key variables
resulted in an analytic sample of n = 4069. There were no systematic differences between
the original and analysis samples.
Practicing DCs who obtain spinal radiographs using radiology devices/machines
within their practice (n = 2985) compared with those who do not have radiology de-
vices/machines in their practice who subsequently refer out to other facilities for PROTS
(n = 1084) were systematically dissimilar on a number of predictors. Pearson chi-square
tests revealed that a country where DCs practiced is a significant predictor of utilizing plain
radiography. Additionally, utilizers versus non-utilizers of spinal radiology significantly
differed on all but one COECR scale item (Q10.5; Investigate red flags [fracture, neurologic
deficits, suspected pathology]). The results for these comparisons are presented in Table 4.

Table 4. Percentage of respondents who do and do not obtain radiographs in their office.

No Radiograph Radiograph
Predictor % n % n χ2
Country 106.34 **
US 24.4% 842 75.6% 2603
Canada 30.8% 137 69.2% 308
Outside US and Canada 58.7% 105 41.3% 74
Q 2.1 442.97 **
No 76.4% 246 23.6% 76
Yes 22.4% 838 77.6% 2909
Q 2.2 450.15 **
No 64.3% 343 35.4% 188
Yes 20.9% 741 79.1% 2797
Q 2.3 603.52 **
No 19.1% 649 80.9% 2751
Yes 65.0% 435 35.0% 234
Q 2.4 950.1 **
No 73.9% 510 26.1% 180
Yes 17.0% 574 83.0% 2805
Q 2.5 564.44 **
No 50.5% 663 49.5% 650
Yes 15.3% 421 84.7% 2335

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Table 4. Cont.

No Radiograph Radiograph
Predictor % n % n χ2
Q 10.1 407.49 **
No 49.1% 558 50.9% 578
Yes 17.9% 526 82.1% 2407
Q 10.2 551.13 **
No 64.5% 409 35.5% 225
Yes 19.7% 657 80.3% 2760
Q 10.3 174.09 **
No 46.0% 341 54.0% 400
Yes 22.3% 743 77.7% 2585
Q 10.4 153.05 **
No 75.0% 93 25.0% 31
Yes 25.1% 991 74.9% 2954
Q 10.5 0.95
No 31.3% 26 68.7% 57
Yes 26.5% 1058 73.5% 2928
Note: ** p < 0.001.

The factor analytic model showed that the items considered for the COECR scale
assess a single trait—clinical opinion and experience regarding the utilization of PROTS in
chiropractic practice. This is a prerequisite for establishing a unidimensional scale. The
only item that impacted the factor in a different (negative) direction was “I order radiography
only for pathology and red flags.” There is an inverse relationship for doctors that only order
radiography for pathology and red flags and the total score on the scale. This means that
DCs scoring higher on this item will score lower on the entire scale and vice versa. The
results of this survey demonstrate that DCs who only order radiography for pathology and
red flags responded in opposition to the other respondents to the survey (see Table 5).

Table 5. Average responses to clinical opinion questions.

Predictor n Mean SD
Q3 4069 4.9 0.44
Q4 4069 4.07 1.12
Q5 4069 4.35 0.98
Q6 4069 4.3 1.02
Q8 4069 1.85 0.65
Q9 4069 4.68 0.73
n = Number of Survey Respondents. SD = Standard Deviation.

Table 5 depicts the differences between utilizers and non-utilizers of plain radiography
as a function of continuous variables included in the survey (Q3, Q4, Q5, Q6, Q8, and Q9).
Independent t-tests revealed that the DCs who were more likely to have X-ray units
in their office believed that their educational and clinical experiences should allow them
to decide whether to utilize plain radiology (p < 0.01; Q3); believed that patient outcomes
would benefit from continued research regarding appropriate utilization of spinal radiology
(Q5); were confident that DCs’ clinical experience together with patient preferences are
adequate and appropriate for recommending PROTS (Q6); and/or believed that sharing
spinal radiographic findings with the patient is beneficial for patient outcomes (Q9).
DCs who believed that PROTS may be risky to a patient’s health were less likely to
have an X-ray unit in their chiropractic office (p < 0.01). Finally, DCs who believed that
they should equally consider all three EBP components when making clinical decisions to

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obtain spinal radiographs were not statistically different from those who did not believe
this in terms of having plain radiography in their office. The effect sizes for statistically
significant results ranged from small to large (see Table 6).

Table 6. Binary logistic regression model predicting position on radiographing chiropractic patients.

Predictor B SE Wald OR
Country
US 1.99 0.17 130.88 7.36 **
Canada 1.16 0.2 33.18 3.17 **
Q 2.1 0.43 0.22 3.96 1.54 *
Q 2.2 0.54 0.18 9.15 1.72 **
Q 2.3 −0.98 0.13 58.52 0.38 **
Q 2.4 1.78 0.13 178.23 5.93 **
Q 2.5 0.80 0.11 57.18 2.23 **
Q3 −0.02 0.11 0.03 0.98
Q4 0.01 0.04 0.09 1.01
Q5 −0.03 0.05 0.38 0.97
Q6 0.06 0.05 1.82 1.06
Q8 0.02 0.07 0.07 1.02
Q9 0.17 0.07 5.27 1.18 *
Q 10.1 0.35 0.11 9.52 1.42 **
Q 10.2 0.34 0.16 4.48 1.4 *
Q 10.3 0.45 0.13 11.45 1.57 **
Q 10.4 0.41 0.31 1.74 1.51
Q 10.5 −0.32 0.31 1.04 0.73
B = Beta. SE = Standard Error. Wald = Wald test. OR = Odds Ratio. ** p < 0.001, * p < 0.05.

3.3. Study 1: Logistic Regression

Binary logistic regression was estimated and tested to determine which of the variables
remain predictive of DCs’ utilization of PROTS after controlling for the variability associated
with all other predictors. Therefore, a binary logistic regression model with Q7 being the
outcome variable and 18 categorical and continuous predictors was estimated and tested.
For the country of practice, the US and Canada were included in the model while the rest of
the world category (outside US and Canada) served as the reference group. For categorical
variables, the lower level (coded as 0) served as a comparison level for the levels coded as
1. The continuous predictors were included in the model as continuous variables.
The overall model revealed statistical significance. The model was evaluated using
Nagelkerke pseudo R2 . All predictors, taken together, accounted for 38% of the variability
in utilization of spinal radiography. The classification of cases was acceptable as the model
correctly classified 48.6% and 94.5%, respectively, of DCs who utilized PROTS in their
chiropractic practice and those who did not. The overall classification was 82% and was
calculated using the following equation:

P(correct classification) = P(y = 1 and ŷ = 1) + P(y = 0 and ŷ = 0)

= P(ŷ = 1|y = 1) P(y = 1) + P(ŷ = 0|y = 0) P(y = 0)

which is a weighted average of sensitivity and specificity [64].

As presented in Table 7, DCs in the US are seven times more likely to utilize plain
radiography, OR = 7.36, p < 0.01, compared to the rest of the world (outside US and Canada),
while DCs practicing in Canada are three times more likely to utilize PROTS, OR = 3.17,
p < 0.01. The DCs who utilized PROTS believed that:
(1) radiographic procedures in a chiropractic office have value beyond the identification
of pathology, OR = 1.54, p < 0.05
(2) radiographs for biomechanical procedures have significant value, OR = 1.72, p < 0.01
(3) radiographic procedures are vital to chiropractic care, OR = 5.93, p < 0.01

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J. Clin. Med. 2023, 12, 2169

(4) radiographic procedures aid in the measurement of clinical outcomes, OR = 2.23,

p < 0.01
(5) that sharing chiropractic clinical findings from radiographic studies with the patient
is beneficial to their clinical outcome, OR = 1.18, p < 0.05
(6) biomechanical analysis or measurements of spinal alignment are valid reasons for
obtaining spinal radiograph, OR = 1.4, p < 0.05
(7) and care plan modification consideration is a valid reason to obtain a spinal radio-
graph, OR = 1.57, p < 0.01.

Table 7. Factorial structure of unidimensional model.

Item Loadings Standard Error

Q 2.1 0.95 ** 0.01
Q 2.2 0.95 ** 0.01
Q 2.3 0.71 ** 0.02
Q 2.4 0.87 ** 0.01
Q 2.5 0.82 ** 0.01
Q 10.1 0.88 ** 0.01
Q 10.2 0.95 ** 0.01
Q 10.3 0.84 ** 0.01
Q 10.4 0.97 ** 0.01
Q 10.5 0.87 ** 0.01
Note: χ2 (35) = 1685.68, p < 0.001; RMSEA = 0.05, 90% CI (0.04, 0.06); CFI = 0.97; TLI = 0.97. ** p < 0.001.
RMSEA = Root-Mean-Square Error of Approximation; CFI = Comparative Fit Index TLI = Tucker–Lewis Index.

Respondents who believed that PROTS should be utilized only for pathology or red
flags were much less likely to use PROTS for the chiropractic practice, OR = 0.38, p < 0.01.

3.4. Study 2: Scale Construction

CFA was conducted using CFA procedures for binary or categorical items. The one-
factor model regressed categorical indicators on a single factor: clinician opinions and
experience on chiropractic radiography. Despite the significant value of the chi-square
statistics, the model produced a good fit to the data: RMSEA = 0.05, 90% CI = (0.04, 0.06);
CFI = 0.97; TLI = 0.97. In general, the chi-square is not considered to be a practical fit index,
because it is strongly affected by sample size [65,66]. The item loadings ranged from 0.71
to 0.97 and were statistically significant (p < 0.001). Initially, item Q2.3 revealed negative
loading on the factor, which was consistent with the previous analyses. The item was
reverse coded to ensure positive loading. The CFA results are presented in Table 7.
The internal consistency reliabilities were estimated using alpha coefficient [47]. The
estimate with original coding of Q2.3 was α = 0.8. There was an increase in internal
consistency after recoding Q2.3: α = 0.84. Both coefficients are high and in support of
a unidimensional scale. Two Rasch models were specified and tested using R Statistical
Software. The first model (M1) was estimated with Q2.3 being originally coded, while the
second model (M2) was estimated with Q2.3 being reverse coded. The results for Rasch
models are presented in Table 6. Two types of fit statistics—infit and outfit indices—were
estimated to assess the fit of the derived scale to the data. The infit is sensitive to unexpected
responses near the item, whereas the outfit is sensitive to unexpected responses far from
the item [67]. In M1, Q2.3 showed a misfit with Outfit MSQ = 12.6. In M2, the infit/outfit
mean square estimates for all COECR items were within their reasonable bounds; thus, the
sequence is considered stable and scalable. Figures 1 and 2 show the item characteristic
curves (ICC) for M1 and M2. The ICC is an S-shaped curve that portrays the probability of
endorsing an item as a function of the latent trait. For M2, the location characteristic (item
difficulty level) was higher for Q2.5 (b = −0.84) and Q10.1 (b = −1.0), while the items that
were easiest to endorse were Q10.5 (b = −3.23) and Q10.4 (b = −3.24).

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J. Clin. Med. 2023, 12, 2169

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Figure 1. IRT Characteristic Curves for Survey Items.

Figure 2. Original (Before Recoding) Distribution of Item Q7.

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J. Clin. Med. 2023, 12, 2169

3.5. Item Response Theory

The authors used the Rasch IRT model to rank the scale items by difficulty, a com-
mon step in scale development. Table 8 presents the results of the Rasch model fit and
Figures 1 and 2 present the graphical ranking of the items before and after the “I order
radiography for pathology and red flags” is recorded. Once again, the Rasch model showed that
DCs who utilize plain radiography of the spine only to rule out pathology in the presence
of red flags are statistical outliers and are significantly inconsistent with the clinical opinion
of the chiropractic profession.

Table 8. Item-level estimates and fit statistics for the Rasch model.

Item χ2 df Difficulty Outfit MSQ Infit MSQ

Q 2.1 1111.56 4110 −1.92 0.27 0.69
Q 2.2 1409.32 4110 −1.51 0.34 0.69
Q 2.3 51,793.5 4110 1.39 12.60 1.32
Q 2.4 2074.18 4110 −1.27 0.51 0.82
Q 2.5 2657.84 4110 −0.55 0.65 0.76
Q 10.1 2027.26 4110 −0.66 0.49 0.66
Q 10.2 1210.89 4110 −1.22 0.30 0.52
Q 10.3 1983.27 4110 −1.09 0.48 0.75
Q 10.4 773.515 4110 −2.15 0.19 0.65
Q 10.5 1707.58 4110 −2.28 0.42 0.86
χ2 = Chi-square. df = degrees of freedom. Outfit MSQ = Outlier-sensitive Fit Mean Square. Infit MSQ = Inlier-
sensitive Fit Mean Square.

3.6. Results Summary

There is an inverse relationship in the responses between DCs that do and do not
utilize PROTS in their practice; however, the clinical opinion of US DCs who utilized
PROTS in their practice assigns a high value to the utilization of PROTS (Tables 5 and 6).
These doctors believe PROTS to be safe and that the DCs’ clinical experience is adequate
for recommending PROTS. (Q6) In summary, 77.6% of these US-based DCs indicated that
PROTS has value beyond the identification of pathology, 79.1% indicate that PROTS is
important regarding biomechanical analysis of the spine, 83.0% noted PROTS to be vital to
chiropractic practice and 84.7% believe PROTS aids in measuring outcomes (Table 4).

4. Discussion
While there is not consensus on the use of PROTS for chiropractic patient management,
we surveyed a national sample of DCs to help clarify this topic with the most extensive
investigation into the clinical expertise of the chiropractic profession regarding utilization
of plain radiography to date. We demonstrate that DCs embrace a spectrum of opinions,
ranging from possible perspectives that, due to safety concerns, utilization of PROTS be
limited to diagnosing pathology in the presence of red flags [68–71] to an absolute necessity
of X-ray images to determine spine and biomechanical parameters [71–73].
EBP includes three categories: published literature, patient preference, and clinician
experience. The clinical experience and expertise of the practicing DCs has been neglected in
the development of guidelines using EBP guidelines despite being an essential component
of the EBP. The results of this study demonstrate that DCs’ clinical experience and expertise
regards PROTS as vital to practice, valuable for patient diagnosis, care, management,
biomechanical assessment, and overall outcomes.
Recent evidence suggests that 73.4% of practicing DCs read peer-reviewed research
about patient management between several times a day to about once a month, and an
additional 22.8% of DCs review published research 1–6 times per year. Further, 40.2% of
practicing DCs review best practice guidelines from several times a day to about once per
month, with another 37.6% reviewing EBP about 1–6 times per year [34] (pp. 106–108).
Given the increasing evidence that chiropractic care has a positive impact on spinal health,
the clinical experience and opinion of DCs should be considered in any practice guideline

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J. Clin. Med. 2023, 12, 2169

development that utilizes EBP as a foundation. Recall that EBP is the equivalent balance
of three components: (1) the best research evidence, (2) clinical experience, and (3) the
patient’s preferences [74]. The best research evidence is clinically relevant, peer-reviewed
research that has been conducted using sound methodology. Clinical experience refers to
the clinician’s cumulative experience, education, and clinical skills in managing patient care,
and patient preference refers to the patient’s unique concerns, expectations, and values.
These three components should be taken into consideration in the decision-making process
for patient care [75].
The results of the survey show that a majority of the respondents utilize plain radiog-
raphy (73.3%) within their practice facility, with 82.9% believing that plain radiography
procedures are vital for chiropractic care. Additionally, 17.1% of DCs who do not utilize
PROTS in their clinics believed that plain radiography is vital for chiropractic care provided.
These findings indicate that the majority of DCs consider plain radiography vital to practice
(Table 4). Respondents were disaggregated into two groups, those who owned an X-ray
machine in their clinic and those who did not, which served as the dependent variable. The
authors of the study analyzed the responses of the two groups on every item in the survey
(the analysis of dichotomous items is presented in Figure 1, and the analysis of continuous
items is presented in Figure 2). The two groups were statistically dissimilar on almost every
survey item, which may suggest that the decision of owning a radiograph system in a
chiropractic clinic goes above and beyond affordability. Believing that utilization of PROTS
is vital to the chiropractic case and these radiographic procedures aid in the measurement
of clinical outcomes emerged as the strongest predictors of having a radiographic system
in a chiropractic clinic. These analyses (see Table 4) confirmed and strengthened previous
findings (see Tables 2 and 3). In addition to analyzing the survey data and reporting the
results, the authors of the study utilized the collected survey responses to construct a scale
(a measurement instrument) for future use. The authors provided a valid and reliable
scale with good internal consistency to assess clinical opinions toward the use of plain
radiography in chiropractic clinical management and is so named the Clinician Opinion
and Experience on Chiropractic Radiography (COECR) scale.
Results from the present study unveiled intriguing differences between those who
choose to perform in-office PROTS and those who do not. The binary logistic regression
analysis revealed that, aside from geography, the strongest predictor of having a radio-
graphy system in a chiropractic practice was an opinion that radiographic procedures
are essential to chiropractic care: DCs who endorsed this item were 6 times more likely
(OR = 5.9) to have a radiography system in their clinics. The second strongest predictor
was the utilization of PROTS to aid measurement of clinical outcomes. DCs adhering to
these views were twice as likely (OR = 2.2) to own a radiographic system. On the other
hand, DCs who took radiographs only when suspecting pathology in the presence of red
flags were much less likely to own a radiographic system in their clinic (OR = 0.4).
The data do not support the assumption that DCs who fully adhere to EBP are less
likely to utilize PROTS for chiropractic case management. The strength of adherence to EBP
was assessed by asking respondents if the clinical decision to obtain spinal radiographs
should be based on all three EBP components. While the majority of respondents agreed or
strongly agreed that all three components should be equally considered (77.7%), there were
no statistically significant differences in utilization of plain film radiography between those
who agreed that all three EBP components should be equally considered and those who
did not (22.3%). Moreover, this question did not emerge as a significant predictor of the
utilization of plain film radiography. These findings suggest that most DCs believe that all
three components of EBP should be considered together.
Regarding the overall clinical opinions and experience of practicing DCs towards
PROTS, 9.5% own a CR digital X-ray system in their practice; 47.7% have a DR digital X-ray
system in the practice; 16.0% own a plain film radiography system; 2.1% do have a plain
radiography system in their facility, but they refer the majority of patients out for PROTS;
and 24.7% do not own any plain radiographic equipment in their chiropractic practice. It is

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J. Clin. Med. 2023, 12, 2169

evident from the survey that DCs who undervalue the use of PROTS are less likely to own
a plain radiography system, while the reverse is true for those who value PROTS as they
are likely to own a radiography system.
There is evidence in the literature to support the rationale for the high clinical opinions
reflected in the survey regarding value of PROTS, the relevance to biomechanical analysis
and the relationship to measuring the outcome. Radiographic measurements such as frontal
and sagittal spine alignment are well demonstrated to be important factors in predicting
spinal health, quality of life and neurological dysfunction [76–82]. Frontal and sagittal
spinal alignment are also correlated with many other radiographic parameters, including
thoracic and pelvic morphology [83–86] Altered spinal balance remains associated with
higher mechanical load and dysfunctional movement patterns and is a possible source of
increased risk of pain and degeneration [87].
It is important to note that the literature also suggests that many of these radiographic
parameters such as sagittal cervical spinal alignment and posture can be corrected with
conservative care and these corrections can be corelated with improved function and
health outcomes [88–102]. Other studies indicate that conservative care can result in
radiographic changes to sagittal lumbar spinal alignment and posture, which is correlated
with improved pain scores and health-related quality of life (HRQOL) [103–107]. Research
has demonstrated that abnormal sagittal thoracic spinal alignment can be corrected, which
is correlated with improvement in the risk of falls, headaches, forced expiratory volume,
and HRQOL [108–115]. Additional studies have demonstrated that conservative correction
of cervical lordosis and forward head posture can be associated with increased HRQOL,
reduced back pain, and improved nervous system adaptability [100]. Coincidently, similar
studies exist within the orthopedic research suggesting that the utilization of PROTS to
measure surgical correction of biomechanical parameters such as sagittal vertical axis,
lumbar lordosis, sacral slope, pelvic tilt and pelvic incidence angle have a direct impact on
predictive surgical outcome, improved Oswestry Disability Index and improved patient
HRQOL [116–120]. The current research suggesting the ability to correct radiographic
parameters provides rationale for the clinical opinion of DCs indicated in the survey that
more research should be dedicated to radiographic utilization in practice.

4.1. Other Findings

Additional findings also offer important insights. Item Q2.3 (I only order radiographs for
pathology or red flags) showed negative factor loading when a one-factor CFA model was
considered. This shows that the item measures the opposite pole of the intended construct,
suggesting a negative linear correlation between the observed item and the latent construct
measured [121]. The issue was echoed when the initial Rasch model was considered in the
estimate of difficulty (the item was the most difficult to endorse) and the values of MSQ.
After the item was reverse coded, the fit of the CFA and Rasch models was improved.
When considering the COECR scale, all items are consistent in producing a total score
except Q2.3 (prior to recoding), which may suggest a different mindset for practitioners who
take radiographs only when pathology is suspected. Although a minority, they strongly
believe that the prudent use of plain radiography does not significantly improve long-term
management of chiropractic patients and that there should be limitations on utilization due
to concerns about safety, ethics, and economics. According to our findings, this is not the
view of today’s practicing DCs.

4.2. Strengths
Methodologically, this is the strongest study in the literature regarding clinical ex-
perience for plain radiography utilization. So far, no study reported in the last 10 years
implemented this level of sophisticated statistical methods combining descriptive analyses,
group differences, predictive modeling, factor analysis, and IRT. The only study that used
predictive methods was that of Pearce et al. [122], but the model in the study was challenged
by the limitations described in the previous sections. For the first time, researchers collected

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a sizable, national sample surveying clinical expertise of the chiropractic profession toward
plain radiograph utilization for chiropractic case management. Although the data from
previous studies show systematic dissimilarities in clinical opinions toward the use of
PROTS for chiropractic management between DCs who own radiographs in their clinics
and those who do not, the items were considered one by one. The predictive model devel-
oped by the researchers in this study considered all items at once. This approach allows for
predictors to reveal statistical significance while controlling for all other variables in the
model. Additionally, our study shows that those who agreed with the statement “I order
radiography for pathology and red flags” are in the minority, which contradicts current trends
in evidence-based practice recommendations. These guidelines tend to dictate the political
stance for the rest of the profession using research that is highly susceptible to bias and
that does not consider biomechanical analysis, treatment strategies, or patient outcome.
This requires further research and visibility in the literature to improve the professional
understanding of the value of plain radiography on patient outcome that is evident in the
clinical opinion of practicing DCs.

4.3. Limitations
This study is an examination of DCs’ clinical opinions and experience on using plain
radiography for chiropractic case management. The findings in this study are novel and
important; however, limitations should be considered. Methodologically, our study’s design
involved a non-experimental approach evaluating cross-sectional variables. Thus, causal
relationships cannot be established between the predictors and the outcomes. As with
many self-report surveys, there were limitations regarding sampling and response biases.
While we informed participants that the survey was anonymous, results may have been
affected by social desirability bias [123]. The authors did not seek outside expertise in the
creation of the survey and did not utilize an initial pilot study; some respondents may have
misinterpreted the definition of red flags which could have skewed some of the responses.
Additionally, it is possible that some DCs have no interest in the topic of utilization of
PROTS, which would have resulted in self-selection bias and a lack of representation from
DCs who are not strongly opinionated toward PROTS. When considering the EBP definition
of clinical experience [75], our survey lacked the ability to determine the level of expertise
and experience as it did not consider items such as years in practice, practice setting, levels
of advanced education, hours of study per week and the financial implications of owning a
radiographic unit. The distribution of the survey link to licensed DCs was based on email
lists that were purchased from publication distribution lists and organizations that had
access to significant national distribution of professionals. Therefore, we did not assign
a priori probabilities to all population units to be selected in the sample. Although we
attempted to minimize subjectivity, the inference of the findings to the target population
may be susceptible to bias [124].
Question-related subjectivity and bias were minimized by constructing questions that
were neutral, answer options that were not leading, survey results that were anonymous,
and ensuring the anonymity of the organizing group. That said, there is no single correct
way to structure a question or provide response options. Different respondents may have
had different perceptions of the same question, which may influence survey responses
and inference of the findings to the target population [124]. Additionally, the dependent
variable in the predictive analysis (Q7) did not ask DCs directly whether they do or do
not support taking spinal radiographs for chiropractic case management, so measuring
clinical opinion was captured indirectly. Despite the limitations, this study provides novel
information about DCs’ clinical opinions toward utilization of PROTS. Researching the
opinions and experience of practicing DCs may clarify the utilization of plain radiography
in chiropractic.

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4.4. Future Research

Respondents indicated a desire for the chiropractic profession to align itself with the
current trends in healthcare and refine our understanding of how to better utilize radio-
graphic interpretation in the prediction and management of spinal health. There is a need
for expanded research from the chiropractic profession to help determine the efficacy of the
clinical opinions represented in this survey. Continued research may include additional sur-
veys, qualitative studies, and observational studies. Additionally, longitudinal comparative
studies are necessary to help understand the impact of spinal correction as measured with
PROTS on patient QOL. Cooperation and joint research with the orthopedic profession
may be beneficial, as there are already many orthopedic studies related to PROTS and the
relationship between surgical biomechanical correction of the spine on QOL.

5. Conclusions
This survey provides the most extensive insight into the clinical opinion of the US
chiropractic profession regarding PROTS and suggests that the majority of the DCs consider
utilization of PROTS to have value beyond the identification of pathology, to be vital to
chiropractic practice and essential to biomechanical analysis. The US DCs who utilized
PROTS only to rule out pathology in the presence of red flags are, in fact, statistical outliers
in this study and may represent a minority of US DCs. A majority of the DCs also consider
the doctors’ clinical experience and expertise, coupled with patient preferences, to be
appropriate for recommending PROTS. Most DCs in this survey found that sharing spinal
radiographic findings with the patient is beneficial for patient outcomes. All participants in
the survey believed that patient outcomes would benefit from continued research regarding
appropriate utilization of PROTS. The results of this survey clearly indicate the value
of PROTS reflected by DCs and demonstrate the need for continued research to help
understand how this value can affect the quality of care, conservative correction of spinal
alignment and patient health.

Author Contributions: Conceptualization, P.A.A.; methodology, S.J.K.; software, S.J.K.; validation,

S.J.K.; formal analysis, P.A.A., S.J.K., D.F.L.; investigation, P.A.A., S.J.K. and D.F.; data curation,
P.A.A., S.J.K. and J.J.; writing—original draft preparation, P.A.A., S.J.K., J.J., D.F.L., D.F. and C.T.;
writing—review and editing, D.F.L. and D.F.; visualization, S.J.K.; supervision, P.A.A.; project admin-
istration, P.A.A. All authors have read and agreed to the published version of the manuscript.
Funding: This research received no external funding.
Institutional Review Board Statement: The study was approved by the Institutional Review Board
of Sherman College of Chiropractic (protocol code ECEUPR09162022).
Informed Consent Statement: Informed consent was obtained from all subjects involved in the study.
Data Availability Statement: All data is represented within the manuscript. Archived datasets
analyzed during this study can be accessed publicly at the following link: https://radevidence.org/
evidence-based-practice/ (accessed on 6 March 2023).
Conflicts of Interest: The authors declare no conflict of interest. Author Steven J. Kraus is an
employee and stock holder in Biokinemetrics, Inc., a digital X-ray company.

Appendix A
Invitation to complete the Survey
Chiropractic Radiology Evidence-Based Practice Survey
Your identity is required to validate you are a DC and only complete the survey once.
This 10-question survey is only for licensed Doctors of Chiropractic. Please complete
this independent survey to help the chiropractic profession evaluate opinions on general
spinal radiography. The survey is not sponsored by any state or national association, nor
any technique group, nor business. None of your contact information will be shared or
published without your permission. Your survey responses, except for name and street

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J. Clin. Med. 2023, 12, 2169

address and email identification data, will be tabulated and published. Your identity is
needed to validate the survey was completed only once by an actual licensed DC. After
completing the survey responses with integrity, you agree to these terms described.
Overall survey results will be emailed to you at the email you provide after all the
survey results are closed, fully tabulated, and published. Please encourage other licensed
DCs to take the survey so that the largest representative sample can be achieved.
Estimated survey completion time: 5 min. Thank you for your thoughtful participation.

Appendix B
Survey distribution numbers and percentage by state of residence.

State N %
AL 352 0.72%
AK 146 0.29%
AZ 1032 2.07%
AR 478 0.96%
CA 7617 15.31%
CO 1304 2.62%
CT 716 1.44%
DE 81 0.16%
DC 30 0.06%
FL 4346 8.74%
GA 1447 2.90%
HI 63 0.13%
ID 399 0.80%
IL 2656 5.34%
IN 465 0.93%
IA 718 1.44%
KS 393 0.79%
KY 722 1.45%
LA 340 0.68%
MA 667 1.34%
MD 375 0.75%
ME 134 0.27%
MI 1823 3.66%
MN 1010 2.03%
MS 264 0.53%
MO 1107 2.23%
MT 172 0.35%
NE 610 1.23%
NV 315 0.63%
NH 188 0.38%
NJ 2455 4.93%
NM 179 0.36%
NY 3462 6.96%
NC 864 1.74%
ND 133 0.27%
OH 2153 4.33%
OK 355 0.71%
OR 654 1.31%
PA 1998 4.02%
RI 80 0.16%
SC 616 1.24%
SD 158 0.32%
TN 557 1.12%
TX 2657 5.34%
UT 519 1.04%
VT 97 0.19%

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J. Clin. Med. 2023, 12, 2169

State N %
VA 601 1.21%
WA 1200 2.41%
WV 108 0.22%
WI 869 1.75%
WY 62 0.42%
Total 49,747 100.00%

Appendix C
Completed survey responses by state and percentage.

State n %
AL 16 0.44%
AK 14 0.38%
AZ 51 1.40%
AR 16 0.44%
CA 423 11.62%
CO 89 2.44%
CT 27 0.74%
DE 3 0.08%
DC 5 0.14%
FL 198 5.44%
GA 199 5.47%
HI 8 0.22%
ID 59 1.62%
IL 159 4.37%
IN 89 2.44%
IA 77 2.11%
KS 31 0.85%
KY 13 0.36%
LA 84 2.30%
MA 41 1.13%
MD 47 1.29%
ME 8 0.22%
MI 259 7.11%
MN 73 2.00%
MS 5 0.14%
MO 38 1.04%
MT 25 0.69%
NE 26 0.71%
NV 43 1.18%
NH 13 0.36%
NJ 87 2.39%
NM 19 0.52%
NY 108 2.97%
NC 71 1.95%
ND 13 0.36%
OH 104 2.86%
OK 23 0.63%
OR 164 4.50%
PA 192 5.27%
RI 7 0.19%
SC 59 1.62%
SD 52 1.42%
TN 37 1.02%
TX 121 3.32%
UT 126 3.46%
VT 6 0.16%

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J. Clin. Med. 2023, 12, 2169

State N %
VA 69 1.89%
WA 152 4.17%
WV 6 0.16%
WI 68 1.87%
WY 18 0.49%
Total 3641 100.00%

Appendix D
Out of 4301 respondents, 1292 clinicians provided additional comments ranging from one
sentence to four paragraphs, which resulted in valuable insights regarding the clinician decision
process for utilization of plain radiography. Some responses commented on multiple topics. A
summary of these the responses could be divided as follows:
• 41% were short comments emphasizing the need for X-rays as an integral and essential tool
within their chiropractic practice.
• 37% commented on the differences between utilization in a chiropractic clinical setting versus a
medical setting.
• 37% described conditions that they found on numerous occasions in which the patient had no
red flags or complaints yet required alteration of care.
• 5% of the comments were related to clinicians supporting the need for this type of survey.
• 4% revolved around comments related to safety.
• Less than 1% commented on question selection.

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 Journal of
Clinical Medicine

Systematic Review
Current Knowledge on the Different Characteristics of Back
Pain in Adults with and without Scoliosis: A Systematic Review
Fabio Zaina 1, *, Rosemary Marchese 2 , Sabrina Donzelli 1 , Claudio Cordani 3,4 , Carmelo Pulici 1 , Jeb McAviney 2
and Stefano Negrini 3,4

1 ISICO (Italian Scientific Spine Institute), 20141 Milan, Italy; [email protected] (S.D.);
[email protected] (C.P.)
2 ScoliCare, Sydney 2217, Australia; [email protected] (R.M.); [email protected] (J.M.)
3 Department of Biomedical, Surgical and Dental Sciences, University “La Statale”, 20122 Milan, Italy;
[email protected] (C.C.); [email protected] (S.N.)
4 IRCCS Istituto Ortopedico Galeazzi, 20157 Milan, Italy
* Correspondence: [email protected]

Abstract: Patients with scoliosis have a high prevalence of back pain (BP). It is possible that scoliosis
patients present with specific features when experiencing back or leg pain pathology. The aim of this
systematic review is to report the signs, symptoms and associated features of BP in patients with
scoliosis compared to adults without scoliosis during adulthood. From inception to 15 May 2023, we
searched the following databases: PubMed, EMBASE, the Cumulative Index to Nursing and Allied
Health Literature (CINAHL), and Scopus. We found 10,452 titles, selected 25 papers for full-text
evaluation and included 8 in the study. We found that scoliosis presents with asymmetrical pain, most
often at the curve’s apex, eventually radiating to one leg. Radiating symptoms are usually localised
on the front side of the thigh (cruralgia) in scoliosis, while sciatica is more frequent in non-scoliosis
subjects. These radiating symptoms relate to rotational olisthesis. The type and localization of the
curve have an impact, with lumbar and thoracolumbar curves being more painful than thoracic. Pain
in adults with scoliosis presents specific features: asymmetrical localization and cruralgia. These were
Citation: Zaina, F.; Marchese, R.; the most specific features. It remains unclear whether pain intensity and duration can differentiate
Donzelli, S.; Cordani, C.; Pulici, C.; scoliosis and non-scoliosis-related pain in adults.
McAviney, J.; Negrini, S. Current
Knowledge on the Different Keywords: scoliosis; low back pain; back pain; disability; lumbar spine
Characteristics of Back Pain in Adults
with and without Scoliosis: A
Systematic Review. J. Clin. Med. 2023,
12, 5182. https://doi.org/10.3390/
1. Introduction
jcm12165182
Idiopathic scoliosis is a three-dimensional spine and trunk deformity of unknown
Academic Editors: Deed Harrison, origin [1]. There are several classifications based on the location and size of the curves and
Ibrahim Moustafa and Paul Oakley according to the age of diagnosis [1]. Usually, idiopathic scoliosis becomes evident during
Received: 1 July 2023
adolescence (AIS), which is the riskiest period for worsening due to rapid growth. Infantile
Revised: 31 July 2023 and juvenile scoliosis are less common but, in many cases, show a more unfavourable
Accepted: 5 August 2023 prognosis [2]. Occasionally, idiopathic scoliosis is diagnosed later, during adulthood, while
Published: 9 August 2023 primary (de novo) degenerative scoliosis refers to a structural curve that develops after
skeletal maturity in a previously normal spine [3]. It is also a fairly frequent condition,
especially in females, with a prevalence of up to 37.6% in people older than 60 years [4].
Despite etiological differences, the clinical impact on Quality of Life (QoL) of idiopathic
Copyright: © 2023 by the authors. and degenerative scoliosis during adulthood can be similar. Studies have shown that
Licensee MDPI, Basel, Switzerland. patients with scoliosis have a higher prevalence of back pain (BP) and experience a more
This article is an open access article severe and longer duration of pain than controls without scoliosis [5]. Pain can eventually
distributed under the terms and radiate distally to one or both legs. Features that distinguish BP related to scoliosis,
conditions of the Creative Commons
as opposed to other potential causes of BP, have yet to be identified. Pain in scoliosis
Attribution (CC BY) license (https://
patients seems to have specific features, including increasing with prolonged standing
creativecommons.org/licenses/by/
while reducing when lying down [5]. Also, the localization of pain seems different in
4.0/).

J. Clin. Med. 2023, 12, 5182. https://doi.org/10.3390/jcm12165182 https://www.mdpi.com/journal/jcm

37
J. Clin. Med. 2023, 12, 5182

patients with scoliosis, with the pain being more asymmetric and principally at the apex of
the curve, on either the side of the prominence or the concavity and frequently radiating
to one of the inferior limbs [6]. Most of the time, the pain is localised in the lumbar spine,
which is subjected to faster degeneration effects; however, in some cases, pain is localised
in the thoracolumbar or in the thoracic spine in the prominent area where the biomechanics
play a major role [7]. This is why authors sometimes refer to BP and other times to low
back pain (LBP).
According to current knowledge, AIS should reach the threshold of 30◦ to be signifi-
cant in adulthood [8,9], while degenerative scoliosis can be painful even at lower degrees [4].
Unfortunately, in everyday clinical practice, it is not always possible to differentiate be-
tween the two forms. We can diagnose scoliosis as indeed being degenerative only if it
is lumbar/thoracolumbar and we have a previous radiograph showing a straight spine.
However, degenerative phenomena may also affect idiopathic scoliosis during adulthood.
According to some estimates, we can expect that by 2050, the proportion of the world’s
population aged greater than 60 years will nearly double [10]. This event will increase the
number of patients with scoliosis presenting to doctors with BP [11]. Therefore, there is
a need to better identify the clinical and associated features of BP in adult patients living
with scoliosis to distinguish whether scoliosis is the underlying cause of BP. Understanding
the features of BP in this group of patients would have clinically relevant outcomes related
to the treatment and prevention of pain.
The primary aim of this systematic review is to report and characterise the signs,
symptoms and associated features of pain (e.g., localization, intensity, duration, modifying
factors) in patients with idiopathic or degenerative scoliosis during adulthood compared to
adults without scoliosis. The hypothesis is that scoliosis patients present specific features
when experiencing back or leg pain connected to the peculiarities of the structural changes
of their spine.
The secondary aim is to differentiate LBP and leg pain features between idiopathic
and degenerative scoliosis.

2. Materials and Methods

2.1. Design
We developed this systematic review based on the MOOSE Reporting Guidelines for
Meta-analyses of Observational Studies [12]. We registered the protocol on PROSPERO
(CRD42023364455).

2.2. Selection Criteria

2.2.1. Type of Study
We included original peer-reviewed primary research articles that were considered a
control group. We considered studies in any language, and we obtained translations where
needed. We excluded secondary research (review articles), case reports and studies that
did not meet the inclusion criteria.

2.2.2. Population
We included adults with scoliosis and BP or LBP. The definition of scoliosis in adults
included adults diagnosed with idiopathic scoliosis as an infant, juvenile or adolescent or
those diagnosed with scoliosis during adulthood (idiopathic or degenerative). We included
these different types of scoliosis because, in clinical practice, it can sometimes be difficult
to be certain whether they are degenerative, idiopathic or even both. Moreover, most of
the published studies presented a mixed population. Finally, despite some differences, we
can expect similar complaints. We excluded studies if the scoliosis was not idiopathic or
degenerative, such as neuromuscular, congenital and other secondary scoliosis. We also
excluded studies if the patients underwent surgical management for their scoliosis. We
included studies of patients treated during adulthood, provided they did not receive any

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J. Clin. Med. 2023, 12, 5182

treatments in the last six months, and considered only the baseline information (i.e., before
any treatment is applied).

2.2.3. Search Strategy

From inception to 15 May 2023, we conducted a literature search in the following
databases: PubMed (via https://pubmed.ncbi.nlm.nih.gov/ accessed on 15 May 2023),
CINHAL (via EBSCOhost), EMBASE (via Embase.com) and Scopus. In addition, we
searched the reference lists of the included studies for other possible studies. We contacted
the authors for studies in which the full text was unavailable. We first developed the search
strategy for PubMed and adapted it to the other databases.
Search strings were composed of search terms defining the “scoliosis” OR “spinal
deformities” AND “low back pain”, “spinal pain” OR “pain”.
The complete search strategies for each database are available in Appendix A. We
imported the search results into the bibliographic management online software Rayyan
(https://www.rayyan.ai accessed on 15 May 2023) after we discarded duplicates on End-
Note X9. We reported the results of the search as per the MOOSE flow diagram (Figure 1).

Figure 1. Study flow chart.

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J. Clin. Med. 2023, 12, 5182

2.2.4. Outcome Measures

The outcomes of interest are the signs, symptoms and associated features of BP and
LBP in adults with and without scoliosis. Pain-related outcomes may include but are
not limited to intensity, duration, type, location (back or distal), onset and triggering
factors/positions, relieving factors/positions, and time-related behaviour. Associated
features may include but are not limited to patient demographics (gender, age, occupation),
number of pregnancies, family history of scoliosis and pain, Cobb angle, number of curves,
types of curve and X-ray features, e.g., osteoporosis, rotational olisthesis.

2.2.5. Study Screening

Two reviewers (CP, FZ) independently screened the titles and abstracts retrieved by
the search strategy and assessed the full-text articles for their potential inclusion. Disagree-
ments were resolved through discussion with another author (RM) to reach a consensus.
We managed these phases by using the Rayyan software.

2.2.6. Data Extraction

Two reviewers (CP, FZ) independently extracted the general characteristics (first author,
publication year, study design, study setting, sample size, participant characteristics) and
outcome data into an Excel form. We solved any differences in opinion about the study
characteristics with a third review author (RM).

2.3. Quality Assessment

Two reviewers (CC, SD) independently assessed the studies’ quality. We solved any
differences in opinion about the methodological quality with a third review author (SN).
We used the JBI checklist, as appropriate.

2.4. Evidence Synthesis and Statistical Analysis

We tabulated the characteristics of the included studies for comparison. We intended
to assess for heterogeneity (e.g., visually, using I2 or the χ2 test) and, if possible, include a
prevalence meta-analysis with weighted proportions. However, due to the small number
and some limitations of the included studies, we performed a narrative synthesis with
frequencies because the meta-analysis was not applicable.

3. Results
3.1. Study Selection
After removing the duplicates from the different databases, we found 10,452 titles
(Figure 1). After the title screening, we selected 25 papers for a full-text evaluation and
included 8 in the study. (Figure 1, Table 1).

40
 Table 1. Characteristics of the included studies.

Lumbar
Type of Curve Presence
Evaluated Scoliosis Severity in of More
Authors Design Setting Participants Sample Age
Pain (AAIS or Degrees than One
De Novo) (Before Curve
Treatment)
J. Clin. Med. 2023, 12, 5182

Non-
Scoliosis
Recruitment Scoliosis
Low back N◦ Mean (SD),
from hospi- N◦ non- Mean (SD), As As As
pain (LBP); scoliosis; Range in
tal/outpatient/ Country scoliosis; Range in reported by reported by reported by
Back pain Female (F) years (as
general popu- Female (F) years (as study study study
(BP) %; reported by
lation reported by
study)
study)
21.2 ±
14% AIS,
11.4◦ (56%
Spine 62.1 ± 12.4 86% only
Perennou prospective 50 (7.5%); F 621 (92.5%); <20◦ , 28%
Rehabilitation France LBP 671 (5 pz < 45 49.6 ± 15.5 discovered lumbar
1994 [13] controlled 36 (72%) F 298 (48%) 20–29; 10%
Unit y) during ex- curves
30–39; 6%
amination
≥40◦
idiopathic
Spine 23.1 ± only
Gremeaux prospective 50 (50%) F 50 (50%); F and degen-
Rehabilitation France LBP 100 62 ± 13.1 62 ± 13.7 13.1◦ lumbar
2008 [6] controlled 68% 66% erative
Unit (10–75◦ ) curves
scoliosis

41
Department of
only
Yuan 2019 cross- Physical 41 (45.5%) 49 (54.5%); 24.95 ± 24.73 ±
China LBP 90 100% AIS 26◦ lumbar
[14] sectional Therapy and F 100% F 100% 2.90 2.83
curves
Rehabilitation
45 pts
thoracic
197 pts 180 pts curve 60◦ ;
Jackson retrospective Department of 377–245 (52%)–101 (48%)–144 idiopathic 16 pts 26 pts tho-
Canada BP 31 36
1983 [7] controlled Orthopaedics report pain pts (51%) pts (80%) scoliosis lumbar 38◦ racolumbar
report pain; report pain 50◦ ; 14 pts
double
curve 55◦ ;
Departments
of Medicine
and
1476 1755
retrospective Department of 3231 (724
Mayo 1994 (45.6%)– (55.4%)–
cohort Occupational Canada/USA BP report 100% AIS
[5] 295 pts 429 report
study Health, and pain)
report pain; pain
Epidemiology
and
Biostatistics
 Table 1. Cont.

Lumbar
Type of Curve Presence
Evaluated Scoliosis Severity in of More
Authors Design Setting Participants Sample Age
Pain (AAIS or Degrees than One
De Novo) (Before Curve
Treatment)
J. Clin. Med. 2023, 12, 5182

24 adult
idiopathic
50.9 (SD
scoliosis, only
Hoevenars retrospective 80 (25%); 240 (75%); 14.1, 50.1 (±12.0, 21.4 (9.4,
Outpatient Netherlands LBP 320 56 de novo lumbar
2022 [15] controlled F 79% F 79% min–max 21–74) 11–72)
degenera- curves
21–76)
tive lumbar
scoliosis;
27.1 ±
11.5◦
primary
curve
(range,
Bissolotti cross- 40 (50%); 40 (50%); Adult
Outpatient Italy LBP 80 61.8 ± 11.5 58.2 ± 10.9 15–63◦ );
2013 [16] sectional F 75% F 77.5% scoliosis
thoracic
curve 25.5
± 22.3◦
(range,
8–58◦ )

42
49.41 (SD
26.38)
(range
15–90) 48 (41%)
lumbar, thoracic
89.54 curve, 14
117 62
<65 y: (32.69) (12%) thora-
Department of 179 (88 (65.3)–71 (34.6%)–17 Late-onset
Weinstein prospective 66 (range, 23/62 (37); (range columbar,
Orthopaedic USA BP report (60%) pts (10.4%) pts idiopathic
2003 [17] controlled 54–80 y) >65 y 39/62 50–155) 32 (27%)
Surgery pain) report pain; report pain; scoliosis
(63) Thora- lumbar, 23
F 89% F 79.4%
columbar, (20%)
84.50 double
(30.17) major
(range
23–156)
thoracic
J. Clin. Med. 2023, 12, 5182

The reasons for exclusion were no study design of interest (nine papers), no population
of interest (five papers) and no outcome of interest (three papers).
Three studies were prospective controlled [6,13,17], three were retrospective [5,7,15],
and two were cross-sectional [14,16]. One of the cross-sectional studies was a congress
abstract [16]. Two studies were from France, two were from Canada, and the others were
from the USA, The Netherlands, China and Italy.
The total number of scoliosis patients was 727, and the controls were 1590.
Three studies included a larger number of adults with scoliosis and healthy controls
but were included because they presented data for the subgroup of patients with BP [5,7,17].
Five studies focused on LBP [6,13–16], while the other three reported on BP, including
both thoracic and lumbar or without giving details on the location [5,7,17].

3.2. Critical Appraisal

Following the JBI checklist, in the cross-sectional studies [14,16], the major limitations
were the absence of strategies to identify and manage confounding factors. Moreover,
in one study [16], the selection criteria and statistical analysis were not completely clear.
Regarding the longitudinal studies [5–7,13,15,17], the main methodological limitations were
associated with the absence of the confounding factors’ identification and the strategies
for managing them, as well as the application of strategies to address incomplete follow-
up visits. Table 2 provides the results of the critical appraisal performed on the studies
included in the present review.

Table 2. Critical appraisal of the included studies.

Cross-Sectional 1 2 3 4 5 6 7
Bissolotti 2013 [16] * Unclear No Yes No No Yes Unclear
Yuan 2019 [14] Yes Yes Yes No No Yes Yes
Longitudinal 1 2 3 4 5 6 7 8 9 10 11
Gremeaux 2008 [6] No Yes Yes No No No Yes Yes No No Yes
Hoevenars 2022 [15] Yes Yes Yes No No No Yes Yes No No Yes
Jackson 1983 [7] Yes Yes Yes No No No Yes Unclear Yes Unclear Unclear
Mayo 1994 [5] No Yes Yes Yes Yes No Yes Yes No No Yes
Perennou 1994 [13] No Yes Yes No No No Yes Unclear Unclear Unclear Yes
Weinstein 2003 [17] No Yes Yes No No No Yes Yes No No Yes
Cross-sectional studies items: (1) Were the criteria for inclusion in the sample clearly defined? (2) Were the
study subjects and setting described in detail? (3) Were objective, standard criteria used for the measurement
of the condition? (4) Were confounding factors identified? (5) Were strategies to deal with confounding factors
stated? (6) Were the outcomes measured in a valid and reliable way? (7) Was appropriate statistical analysis
used? Longitudinal studies items: (1) Were the two groups similar and recruited from the same population?
(2) Were the exposures measured similarly to assign people to both exposed and unexposed groups? (3) Was the
exposure measured in a valid and reliable way? (4) Were the confounding factors identified? (5) Were strategies
to deal with the confounding factors stated? 6) Were the groups/participants free of the outcome at the start of
the study (or at the moment of exposure)? (7) Were the outcomes measured in a valid and reliable way? (8) Was
the follow-up time reported and was it sufficient to be long enough for outcomes to occur? (9) Was a follow-up
complete, and if not, were the reasons for the lack of a follow-up described and explored? (10) Were strategies
to address incomplete follow-up utilised? (11) Were the strategies to address the incomplete follow-up utilised?
* Conference abstract.

3.3. Main Findings

The description of symptoms (localization, intensity, disability and functional status)
varied among the different papers. Five studies reported pain localization, five studies
reported pain severity and/or disability in adults with scoliosis compared to non-scoliosis
subjects and two papers reported on the factors influencing pain (Table 3).

43
 Table 3. Symptom characteristics provided by the included studies.

Authors Severity/Intensity of Pain Location of BP Referred/Lower Extremity Symptoms Functional Status

Scoliosis Non-Scoliosis Scoliosis Non-Scoliosis Scoliosis Non-Scoliosis Scoliosis Non-Scoliosis
40% radicular pain: 44.3% radicular
Perennou 1994
_ _ _ _ 26% Sciatica, 14% pain: 38% Sciatica, _ _
[13]
cruralgia 6.3% cruralgia
J. Clin. Med. 2023, 12, 5182

56% (sciatica 26%;

cruralgia 26%,
neurological
44% (sciatica 32%;
claudication 10%,
cruralgia 12%,
buttock pain 30%),
neurological
Inguinal dysesthesia
60% little or usual; 68% little or usual, claudication 8%,
Gremeaux 2008 30%, 10% costo-iliac
40% considerable 32% considerable _ _ buttock pain 34%) _ _
[6] syndrome; Buttock
or severe or severe Inguinal
pain (20% little or
dysesthesia 6%;
usual; 45%
0% costo-iliac
considerable or severe)
syndrome
Inguinal pain (16.6%;
70%) Obturator
neuralgia (3.3%; 30%)
32 (78%) left-sided
lumbar pain, 9 (21%)
83.7% midline or
Yuan 2019 [14] 3.5 NRS 5.5 NPRS right-sided lumbar _ _ _
symmetrical pain
pain; 78% pain on

44
the convex side
44% pain at lower
junctional segment
/compensatory
curves below the
major deformity;
DM: 35% mainly
junctional area, 44%
localised pain in 65% of patients
lower junctional complained of limb
3.3 (scale from 0 to
Jackson 1983 [7] _ levels and in lesser distress, including _ _ _
5)
curves below. TL buttock and thigh
and L mainly pain, before treatment.
junctional and
fractional curve
segments below MC
in 46% and 44%;
lumbosacral
half-curve segment
was most painful.
 Table 3. Cont.

Authors Severity/Intensity of Pain Location of BP Referred/Lower Extremity Symptoms Functional Status

Scoliosis Non-Scoliosis Scoliosis Non-Scoliosis Scoliosis Non-Scoliosis Scoliosis Non-Scoliosis
Limitations in
lifting,
walking,
Spreading pain
standing,
J. Clin. Med. 2023, 12, 5182

(curves > 40◦ ),

Mayo 1994 [5] _ _ _ _ _ travel, sitting. _
generalised back
Need to
pain (curves > 20◦ )
change
position and
lie down/rest.
Hoevenaars 39.5 (±12)
58.4 (19.1) NRS 60.4(19.1) _ _ _ _ 40.2 (±12.1) ODI
2022 [15] ODI
Bissolotti 2013 NRS 5.9 ± 1.8 33.9 ± 17%
5.1 ± 2.2 _ _ 27% sciatic pain 47% (sciatic pain) 32.6 ± 18.8% ODI
[16] (range 2–10) ODI
Little/moderate Little/moderate
score 1–2: 48/71 score 1–2: 12/17
37 pts (39%) 16 pts (30%) felt
Weinstein 2003 (68%); quite (71%); quite
_ _ _ _ felt they had a they had a
[17] bad/unbearable bad/unbearable
disability disability
score 3–5: 23/71 score 3–5: 5/17
(32%) (29%)
Abbreviations: pts: patients; BP: back pain; DM: double major; TL: thoracolumbar; L: lumbar; MC: major curve.

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J. Clin. Med. 2023, 12, 5182

3.4. Pain Localization

Five papers reported pain localization [6,7,13,14,16]. Two papers reported on a similar
population of older people, and therefore we pooled their data [6,13]. One was about
younger subjects [14]. One congress abstract reported sciatica prevalence [16].
In two studies, adults with scoliosis and LBP experienced more frequent radiating pain
and cruralgia (defined as compressive nerve root irritation of L3–L4 [18]) than the control
group of LBP patients without scoliosis (48 vs. 37.5% and 20% vs. 6.7%, respectively), and
sciatica was more frequent in patients without scoliosis (26% vs. 44%) [6,13]. A congress
abstract reported similar significant findings (27 vs. 47%) [16]. Cruralgia was associated
with rotatory dislocation (olisthesis) [6,13].
In one paper reporting on the younger adult population, all the scoliosis patients
experienced unilateral lumbar pain (78% of the time on the convex side), while 83.7% of
patients without scoliosis experienced midline or symmetrical lumbar pain [14].
Considering the back area, the most common localization of pain was over the major
deformity in scoliosis. In a double major curve, the pain was frequently at the distal curve,
while in thoracic curves, the pain was at the distal junctional level [7].

3.5. Pain Intensity and Disability

Five studies described pain intensity and disability [5,12,14,16,18]. One study reported
pain intensity and frequency at 50 years of follow-up [17]. The authors reported that pain
intensity and duration were similar between scoliosis and non-scoliosis adult patients with
BP [17]. They also created a more complete pain composite, summing the pain intensity
and duration. Also, this parameter showed similar trends in both groups [17].
One congress abstract reported similar findings for pain and disability in scoliosis and
non-scoliosis adults with LBP [16]. The numerical rating scale (NRS) values were 5.9 ± 1.8
for scoliosis patients versus 5.1 ± 1.2 for the controls, while the Oswestry Disability Index
(ODI) values were 33.9 ± 17.6% versus 32.6 ± 18.8% [16].
A retrospective study included subjects with chronic BP who failed a primary care con-
servative treatment approach and were referred to a combined physical and psychological
program. The authors found no differences at the baseline for pain intensity (58.4 ± 19.1
vs. 60.4 ± 19.1 for NRS), functional status (39.5 ± 12.0 vs. 40.2 ± 12.1 for ODI), or pain
duration (15.5 vs. 13.6 years) [15].
On the contrary, two retrospective studies reported more frequent pain in scoliosis
patients [5,7]. One study found that current BP and prevalence of BP over the last year
were higher for scoliosis than non-scoliosis adults, without any impact of curve entity [5].
In scoliosis patients, the pain was more continuous and chronic [5]. The other study found
that adults with scoliosis had more severe, constant or frequent pain, while non-scoliosis
patients referred more occasional or recurrent pain [7].

3.6. Factors Influencing Pain

Two papers reported data on the factors influencing pain [5,7]. One paper reported
details from the Roland Morris Scale (RM), the ODI and McGill Pain Questionnaire [5].
Compared to non-scoliosis BP patients, adults with scoliosis and BP showed a more frequent
need to change position, with limitations in standing and sitting for a long time [4]. Patients
with curves larger than 40◦ also showed limitations in walking, and those with curves
between 20◦ and 40◦ had limitations in lifting and travelling [5]. Issues related to social
activity, personal care and the need for pain control were similar among the two groups [4].
One retrospective study reported that major lumbar, thoracolumbar and lumbosacral curves
were the most painful, while major thoracic was the least painful [7].

4. Discussion
There is evidence that adults with scoliosis frequently report pain issues. In clinical
practice, it is sometimes difficult to understand whether the pain relates to the spinal
deformity or is nonspecific [19]. BP is so common that there are cases in which it affects

46
J. Clin. Med. 2023, 12, 5182

someone with scoliosis just by chance. To help clinicians, we designed this systematic
review to report the available information on the topic. Only a few studies compared
BP in scoliosis and non-scoliosis subjects. According to the data reported in our review,
scoliosis presents with asymmetrical pain, which is, for most of the time, lumbar and at the
curve’s apex, eventually radiating to one leg. Radiating symptoms are usually localised
on the front side of the thigh (cruralgia), while sciatica is more frequent in non-scoliosis
subjects. These radiating symptoms relate to rotational olisthesis [6,13], consistently with
other reports [20,21]. Also, the type and localization of the curve have an impact, with
lumbar and thoracolumbar ones being more painful than thoracic [7]. In thoracic curves,
the painful area is usually distal to the curve [7].
Other features of pain in scoliosis are related to difficulty standing and eventually
sitting for a prolonged time, where lying down seems to relieve symptoms [5]. Travelling
and lifting seem challenging for patients with curves between 20◦ and 40◦ , while for those
with larger curves, walking seems problematic [5]. We can hypothesise that these symptoms
are associated with spine stiffness, which typically characterises scoliosis, and the altered
biomechanics of the spine due to frontal and/or sagittal imbalance. We can also speculate
that upper spine pain and fatigue are symptoms that start earlier, before degeneration, and
could be more related to the altered biomechanics of the spine, whereas radiating LBP
is a typical complaint of patients with degeneration in the lumbar spine; however, more
clinically descriptive studies are needed to investigate these speculations.
Data from the papers included in this review are inconsistent regarding pain intensity
and the duration of symptoms. Some studies reported more intensity and duration of
symptoms in adults with scoliosis and BP [5,7]. In contrast, others found no difference
compared to the control groups of non-scoliosis subjects [16,17].
Reporting about disability is challenging, too. Data collected from the ODI show no
differences between scoliosis and non-scoliosis subjects [16]; however, some differences
appear with the Roland Morris Scale and the McGill Questionnaire [5]. The ODI may
not be suitable for capturing the disability of scoliosis patients. Recently, a study about
bracing in adults with scoliosis and BP reported good results on pain and the Core Outcome
Measurement Index (COMI), but no changes were recorded for the ODI [22,23]. Therefore,
the application of the ODI in this specific group of patients seems questionable, and more
specific tools are under investigation and applied in routine clinical practice [24,25].
Scoliosis is a three-dimensional trunk deformity that leads to global imbalance. In
adult scoliosis, trunk imbalance has been suggested as one of the most crucial elements
in pain generation; however, the studies that suggest this fell outside of the inclusion
criteria of our study, mostly because they lacked control groups. The Schwab classification
tried to help understand the pattern and risk factors of pain [9]; however, some papers
questioned the role of such parameters in lumbar degenerative scoliosis [26]. As the
evidence grows, we hope that the quality of evidence is such that we can compare the role
of trunk imbalance in scoliosis and non-scoliosis populations and the relationship to LBP.
As we already stated, it is possible that a patient with scoliosis experienced nonspecific LBP,
and the findings of this review will help clinicians in everyday practice. It is important
to recognise specific features of pain to correctly classify patients with scoliosis and BP
to provide appropriate specific treatment. We need to bear in mind that LBP is very
frequent in the adult population, and the disadvantaged biomechanics of the spine with
scoliosis can represent a risk factor for these patients. If the features of pain are well-known,
specific treatment can be applied when appropriate, with exercise [27] and bracing showing
different degrees of effectiveness [28].
Due to the increasing prevalence of spinal deformities in adulthood, linked to the
progressive ageing of the population, and the need for clinicians to identify a clear clinical
picture for appropriate treatments, it is of major importance to identify what is known
(signposting the relevant papers to clinicians) and what is unknown (driving future research
efforts). A systematic review is an appropriate methodology to answer these needs. Due
to the expected scarcity of papers, we considered a wide approach to collect all possible

47
J. Clin. Med. 2023, 12, 5182

information. What we found clearly shows the need for much more and higher quality
research in the field. Clinicians need to know if their patient’s BP is due to a spinal deformity
or if it is a common BP similar to patients without deformities. The next research step can
be gathering consensus among experts to determine the current clinical understanding and
develop research hypotheses for future studies.

Study Limitations
One limitation was the different outcome measures used in the different studies. A
standard method for measuring pain was missing. Some papers applied ordinal scales,
and others the NRS. For pain frequency and duration, some reported the year, and others
used descriptive scales. All these elements, together with the small number of retrieved
studies, prevented performing a meta-analysis. Some adults with scoliosis seek a clinical
visit to check the evolution of their curves, while other times, for disability or pain. They
may be used to experiencing some pain and fatigue in their everyday life, and therefore
it is possible that they are frequently not concerned about their symptoms but may be
worried about progression. This behaviour may justify the confusion regarding the pain’s
features and characterization. This highlights the need for further studies describing the
pain features in scoliosis adults compared to adults with BP without scoliosis.
No study reported a direct comparison of pain in degenerative and idiopathic scoliosis,
making it impossible to determine any difference between the two populations. Degenera-
tive de novo scoliosis is not easy to diagnose, and it is possible that clinicians are not sure if
it is a de novo scoliosis rather than idiopathic with a delayed diagnosis.
Unfortunately, the quality of the included studies is low. Moreover, just a few of them
focused on the clinical features of LBP in adults with scoliosis. More research is needed in
the field; therefore, we suggest starting with a consensus among experts to better define the
most relevant features to investigate according to the available data and clinical experience
and then designing appropriate clinical studies.

5. Conclusions
Pain in adults with scoliosis and BP seems to present specific features. Its localization,
usually asymmetrical and associated with cruralgia, was the most specific feature. It
remains unclear whether pain intensity and duration can differentiate scoliosis and non-
scoliosis adults with BP. Further studies are needed to better understand BP in adults with
scoliosis and provide specific treatment recommendations.

Author Contributions: Conceptualization, F.Z. and R.M.; methodology, C.C., C.P. and S.D.; data
extraction F.Z., C.P. and R.M.; formal analysis, J.M. and S.N.; writing—original draft preparation, F.Z.
and R.M.; writing—review and editing, all authors; supervision, S.N. and J.M. All authors have read
and agreed to the published version of the manuscript.
Funding: This research received no external funding.
Institutional Review Board Statement: Not applicable.
Informed Consent Statement: Not applicable.
Data Availability Statement: Not applicable.
Acknowledgments: This study was supported and funded by the Italian Ministry of Health—Ricerca
Corrente (2023). The authors wish to thank Federico Zaina for the original drawings of the graphi-
cal abstract.
Conflicts of Interest: S.N. owns ISICO stock. J.M. owns Scolicare stock. All other authors have no
conflict of interest to declare.

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J. Clin. Med. 2023, 12, 5182

Appendix A
Inception to May 2023
Databases: PubMed (via pubmed-ncbi.nlm.nih.gov/ accessed on 15 May 2023), CIN-
HAL (via EBSCOhost), EMBASE (via Embase.com) and Scopus, from inception to May
2023.
PubMed (via pubmed-ncbi.nlm.nih.gov/ accessed on 15 May 2023)
1. (“spinal curvatures”[MeSH Terms]) OR (scoliosis[MeSH Terms]);
2. ((“spinal curvatures*”[Title/Abstract]) OR (scoliosis*[Title/Abstract]) OR (“spinal
deformit*”[Title/Abstract]);
3. #1 OR #2;
4. (back pain[MeSH Terms] OR sciatica[MeSH Terms] OR radiculopathy[MeSH Terms]);
5. ((low back pain*[Title/Abstract]) OR (back pain*[Title/Abstract]) OR (spinal pain[Title/
Abstract]) OR (backache*[Title/Abstract]) OR (back ache*[Title/Abstract]) OR
(aching[Title/Abstract]) OR (lumbar pain[Title/Abstract]) OR (lumbo*[Title/Abstract])
OR (back disorder*[Title/Abstract]) OR sciatic*[Title/Abstract] OR radiculopat*[Title/
Abstract]);
6. #4 OR #5;
7. #3 AND #6.
EMBASE (via Embase.com)
8. (‘scoliosis’/exp OR ‘spinal pain’/exp OR ‘spine malformation’/exp);
9. (‘spine diseas*’:ab,ti,kw OR ‘spinal curvature*’:ti,ab,kw OR ‘idiopathic* scoliosis’:ti,ab,kw
OR ‘degenerative* scoliosis’:ti,ab,kw OR ‘de novo* scoliosis’:ti,ab,kw OR ‘spine mal-
format*’:ti,ab,kw OR ‘spinal deformit*’:ti,ab,kw OR ‘scoliosis*’:ti,ab,kw);
10. #1 OR #2;
11. ‘backache’/exp OR ‘sciatica’/exp;
12. (‘backache*’:ti,ab,kw OR ‘back pain*’:ti,ab,kw OR ‘low back pain*’:ti,ab,kw OR ‘scolio-
sis*’:ti,ab,kw OR ‘spinal pain*’:ti,ab,kw OR ‘back ache*’:ti,ab,kw OR ‘lumbar pain*’:ti,ab,kw
OR ‘lumbo*’:ti,ab,kw OR ‘aching’:ti,ab,kw OR ‘back disorder*’:ti,ab,kw OR ‘sciatic*’:ti,ab,kw
OR ‘radiculopat*’:ti,ab,kw);
13. #4 OR #5;
14. #3 AND #6.
Scopus
15. TITLE-ABS-KEY(“spinal curvature*” OR “scoliosis*” OR ((“idiopathic*” OR “degen-
erativ*” OR “de novo*”) W/1 (“scoliosis”)));
16. TITLE-ABS-KEY(“back pain*” OR “low back pain*” OR ((“spinal” OR “lumbar”) W/1
(“pain*”)) OR “backache*” OR “back ache*” OR “aching” OR “lumbo*” OR “back
disorder*” OR “sciatic*” OR “radiculopat*”)));
17. #1 AND #2.
CINAHL (via EBSCOhost)
18. (MH “Spinal Curvatures+”) OR (MH “Scoliosis+”);
19. TI ((spinal W1 curvatures*) OR “scoliosis*” OR ((idiopathic* OR degenerativ* OR
de novo*) N1 (scoliosis))) OR AB ((spinal W1 curvatures*) OR “scoliosis*” OR ((idio-
pathic* OR degenerativ* OR de novo*) N1 (scoliosis))) OR SU ((spinal W1 curvatures*)
OR “scoliosis*” OR ((idiopathic* OR degenerativ* OR de novo*) N1 (scoliosis)));
20. #1 OR #2;
21. (MH “Back Pain+”) OR (MH “Sciatica”) OR (MH “Radiculopathy”);
22. TI (((back OR spinal OR lumbar) N1 (pain*)) OR backache OR sciatic* OR radicu-
lopat*OR (back W1 ache*) OR aching OR lumbo* OR (back W1 disorder*)) OR AB
(((back OR spinal OR lumbar) N1 (pain*)) OR backache OR sciatic* OR radiculopat*OR
(back W1 ache*) OR aching OR lumbo* OR (back W1 disorder*)) OR SU (((back OR
spinal OR lumbar) N1 (pain*)) OR backache OR sciatic* OR radiculopat*OR (back W1
ache*) OR aching OR lumbo* OR (back W1 disorder*));

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J. Clin. Med. 2023, 12, 5182

23. #4 OR #5;
24. #3 AND #6.

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 Journal of
Clinical Medicine

Article
Measuring Quality of Life in Adults with Scoliosis:
A Cross-Sectional Study Comparing SRS-22 and
ISYQOL Questionnaires
Fabio Zaina 1 , Irene Ferrario 1 , Antonio Caronni 2,3, *, Stefano Scarano 2,3 , Sabrina Donzelli 1
and Stefano Negrini 4,5

1 ISICO (Italian Scientific Spine Institute), Via Roberto Bellarmino 13/1, 20141 Milan, Italy
2 IRCCS, Istituto Auxologico Italiano, Department of Neurorehabilitation Sciences, Ospedale San Luca,
20149 Milan, Italy
3 Department of Biomedical Sciences for Health, Università degli Studi di Milano, 20133 Milan, Italy
4 Department of Biomedical, Surgical and Dental Sciences, University “La Statale”, 20122 Milan, Italy
5 IRCCS Istituto Ortopedico Galeazzi, 20157 Milan, Italy
* Correspondence: [email protected]

Abstract: Idiopathic scoliosis is common in adulthood and can impact patients’ physical and psycho-
logical health. The Scoliosis Research Society-22 Questionnaire (SRS-22) has been designed to assess
health-related quality of life (HRQOL) in idiopathic scoliosis, and it is the most used disease-specific
outcome tool from adolescence to adulthood. More recently, the Italian Spine Youth Quality of
Life (ISYQOL) international questionnaire was developed, which performs better than SRS-22 in
adolescent spinal deformities. However, the ISYQOL questionnaire has never been tested in adults.
This study compares the construct validity of ISYQOL and SRS-22 with the Rasch analysis (partial
credit model). We recruited 150 adults and 50 adolescents with scoliosis (≥30◦ Cobb). SRS-22, but not
ISQYOL, showed disordered categories and one item not fitting the Rasch model. A 21-item SRS-22
version with revised categories was arranged and further compared to ISYQOL. Both questionnaires
showed multidimensionality, and some items (SRS-22 in a greater number) functioned differently
in persons of different ages. However, the artefacts caused by multidimensionality and differential
Citation: Zaina, F.; Ferrario, I.; functioning had a low impact on the questionnaires’ measures. The construct validity of ISYQOL
Caronni, A.; Scarano, S.; Donzelli, S.; International and the revised SRS-22 are comparable. Both questionnaires (but not the original SRS-22)
Negrini, S. Measuring Quality of Life can return measures of disease burden in adults with scoliosis.
in Adults with Scoliosis: A
Cross-Sectional Study Comparing Keywords: quality of life; adult scoliosis; rasch analysis; psychometrics
SRS-22 and ISYQOL Questionnaires.
J. Clin. Med. 2023, 12, 5071. https://
doi.org/10.3390/jcm12155071

Academic Editors: Deed Harrison, 1. Introduction

Ibrahim Moustafa and Paul Oakley Spinal deformities, such as scoliosis, may significantly impact patients’ physical and
Received: 28 June 2023
psychological health [1]. Adolescents with idiopathic scoliosis can show psychological
Revised: 20 July 2023 and emotional distress, with anxiety as the most common symptom [2]. They may exhibit
Accepted: 29 July 2023 poorer psychosocial functioning and body image than their healthy peers, while adults
Published: 1 August 2023 with scoliosis show concerns about the risk of disability, body image, and physical health
problems [3]. During adulthood, this pathology can cause lower back pain, bent posture,
shortness of breath, and reduced autonomy in everyday activities [4]. Disease-specific
outcome tools can assess the extent of this impact, e.g., the Scoliosis Research Society-22
Copyright: © 2023 by the authors. Questionnaire (SRS-22), the most used instrument to assess health-related quality of life
Licensee MDPI, Basel, Switzerland. (HRQOL) in patients with idiopathic scoliosis [5]. Initially developed [5,6] in a young
This article is an open access article population, many studies have examined its application for adult spinal deformities,
distributed under the terms and
demonstrating its usefulness in this population [7–9]. Nevertheless, other papers showed
conditions of the Creative Commons
drawbacks and limitations [10].
Attribution (CC BY) license (https://
When used as an HRQOL measure, the SRS-22, developed in the classical test theory
creativecommons.org/licenses/by/
framework (CTT), the oldest set of psychometrics techniques for developing scales and
4.0/).

J. Clin. Med. 2023, 12, 5071. https://doi.org/10.3390/jcm12155071 https://www.mdpi.com/journal/jcm

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J. Clin. Med. 2023, 12, 5071

questionnaires, has a significant flaw: its total ordinal score is not a measure but a measure
approximation at best [11]. Equal changes in ordinal scores do not necessarily reflect identi-
cal changes in the quantity of the variable of interest. This fact has practical consequences:
customary statistics such as effect size can be misleading when calculated on ordinal scores.
Like CTT, the Rasch analysis is a statistical method designed to build and assess
questionnaires. If a questionnaire’s score empirically demonstrates compliance with the
assumptions of the Rasch analysis, it is possible to turn these total scores into actual interval
measures [11].
Rasch’s analysis revealed that the SRS-22 has poor metric properties, failing to assess
HRQOL properly in non-surgical adolescents and children [12]. Therefore, we developed
the Italian Spine Youth Quality of Life (ISYQOL), using Rasch analysis, as a new patient-
reported outcome measure to assess HRQOL in adolescents with spinal deformities [13].
ISYQOL had satisfactory construct validity and, compared to SRS-22, better known-groups
validity, detecting the impact of disease severity on HRQOL [14]. More recently, a different
version called “ISYQOL International” has been validated in a multicentre international
study, the cross-culturally equivalent version of the questionnaire [15].
To our knowledge, no other Rasch-consistent questionnaire measuring HRQOL in
adults with spinal deformities is available, and the data on ISYQOL’s and ISYQOL Interna-
tional’s validity come solely from the adolescent population. Therefore, the present study
aims to verify the construct validity of ISYQOL International and to compare its properties
to the SRS-22 in adults with scoliosis. We hypothesize that the ISYQOL can perform at least
as well as the SRS-22 in adults with scoliosis. Moreover, we expect ISYQOL to perform
similarly in adults and adolescents with scoliosis.

2. Materials and Methods

2.1. Study Characteristics
We conducted a cross-sectional study based on data from an ongoing prospective
database collecting records from patients attending a tertiary outpatient clinic specializing
in the conservative treatment of spinal deformities in Italy.

2.2. Data Collection

As standard practice, all patients attending our rehabilitation centre complete the
self-administered SRS-22 and ISYQOL questionnaires before every medical consultation.

2.3. Participants
On 8 October 2022, we extracted all consecutive patients respecting the following
criteria: (1) age ≥18 years, (2) diagnosis of idiopathic scoliosis with a curve of 30◦ Cobb or
more, and (3) availability of both the ISYQOL and SRS-22 questionnaires. Exclusion criteria
were the following: (1) history of spine surgery, (2) history of relevant diseases, surgery,
or trauma, and (3) a positive neurologic examination. Only questionnaires not exceeding
two missing answers were included in the analysis. From this group, we randomly extracted
150 patients. Since we expected that age could impact the results of the questionnaires, we
made a cluster sampling based on age and sex. We had six groups based on age: 20–29, 30–39,
40–49, 50–59, 60–69, and 70–79 years. For each group, we extracted 20 females and five males
as per the different sex prevalence of spinal deformities. This is based on the published
literature and our data. A systematic review has reported a prevalence of degenerative
scoliosis of 41.2% for females versus 27.5% for males [16]. Considering idiopathic scoliosis,
the ratio is 7/1 in favour of females [1]. In our database, which includes a mixed population,
the ratio is about 4–5/1 for all kinds of scoliosis during adulthood.
Moreover, we randomly extracted a sample of 50 individuals aged between 14 and
18 years from the dataset we analysed in our previous study for the ISYQOL validation
study [14]. We included ten participants for each of the five years of age (eight females and
two males), all affected by idiopathic scoliosis and all not wearing a brace.

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2.4. Sample Size Calculation

In the Rasch analysis framework, about 200 questionnaires are usually enough to
produce stable estimates [17]. In addition, we arranged age subgroups of equal size
to comply with some recent guidelines and recommendations for the differential item
functioning (DIF) analysis (see below) [18,19].

2.5. Health-Related Quality-of-Life Questionnaires: SRS-22 and ISYQOL

The SRS-22 questionnaire [5] consists of 22 items scored on five ordinal categories
(1–5), with higher scores corresponding to a lower disease burden and, thus, better quality
of life. It measures specific aspects of HRQOL, covering five domains: self-image, mental
health, pain, function, and treatment satisfaction [20,21].
ISYQOL International derives from ISYQOL. We translated ISYQOL into different
languages and assessed its cross-cultural validity. We removed four items from the original
questionnaire [15]. The ISYQOL International consists of 16 items scored on three categories
(0–2); the higher the category numeral, the more the disease burden. The ordinal ISYQOL
total score is converted into an interval measure with logit as the measurement unit (the
higher the logit measure, the higher the disease burden). The ISYQOL ordinal score can also
be expressed on an interval scale ranging from 0 to 100%, with 100% indicating an excellent
quality of life. It consists of two subscales, one (9 items) regarding spine health and the
other (7 items) regarding brace wearing. Only the ISYQOL International spine domain was
collected here since no participant wore a brace at the point of inclusion in the study.

2.6. Statistical Analysis

We ran the Rasch analysis in the following steps [12,13,15] (Appendices A and B).

2.6.1. Categories’ Functioning

The categories’ functioning was evaluated by assessing their average order, as per
Linacre [22], and the order of the modal thresholds, as per Andrich [23].

2.6.2. Fit the Model

We can extract measures from the questionnaire’s scores if categories are ordered and
data fit one of the Rasch family models (here, Masters’ partial credit model [24]).
We used the mean square (MnSq) and the z-standardised (Z-Std) statistics (“infit”
and “outfit” variants) to quantify the departure of the observed data from the model’s
prediction and the probability that this departure was due to chance, respectively.
Here, an item was considered to “misfit”, i.e., not fit the model adequately, if:
outfit MnSq > 2.0 and absolute outfit Z-Std > 1.96, or
infit MnSq > 1.5 and absolute infit Z-Std > 1.96.

2.6.3. Dimensionality
Measures are unidimensional, meaning they reflect a single variable’s amount. In the
Rasch framework, principal components with an eigenvalue >2 from a principal component
analysis (PCA) calculated on the model’s residuals indicate multidimensionality.
In the case that multidimensionality is found, whether this multidimensionality harms
measurements can be tested by assessing if cluster 1 items (items with a large and positive
loading on the principal component) and cluster 3 items (items with a large and negative
loading) return a different participants measure from cluster 2 items (those items loading low
on the principal component, thus reflecting only the variable grasped by the model of Rasch).
Suppose persons’ measures from cluster 1 and cluster 3 are comparable. In that case,
the artefact caused by the hidden variable highlighted from the principal component is
not strong enough to cause a severe measurement artefact [25]. For this comparison, we
used ANOVA.

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2.6.4. Differential Item Functioning

Differential item functioning (DIF) indicates that an item does not work the same in
different groups of respondents. Given the study’s aim, the current analysis focused on
the DIF for age. We reorganized the participants’ sample into the following age classes:
adolescents (from 14 to 18 years), young adults (from 20 to 39 years), middle-aged adults
(from 40 to 59 years) and older adults (from 60 to 79 years). As a complementary analysis,
we evaluated DIF for gender (males vs. females). We tested the DIF of SRS-22 and ISYQOL
International items following Linacre [25].
Suppose the calibration of an item is different in a subgroup of participants and in the
primary analysis. If this difference is <0.5 logit with p > 0.01, the DIF can be considered too
small to matter.
In the case of a large (>0.5 logit) and significant (p < 0.01) DIF being found for an item,
the observed scores of the participants’ subset on this item and their expected scores are
compared to provide an easy understanding of the artefact caused by the DIF in terms of
the questionnaire’s total score.

2.6.5. Questionnaire Reliability and Targeting

We reported the ISYQOL International and the SRS-22 reliability as “Rasch persons’
reliability”, similar to Cronbach’s alpha. From this reliability index, we calculated the
number of strata, the number of significantly different levels of the disease burden a person
can progress through (Supplementary Materials 1 in [26]).
Floor and ceiling effects were calculated as the percentage of respondents obtaining the
minimum and maximum total questionnaire scores, respectively. The size of the difference
between the persons and the items measures complements this information. A questionnaire
with no floor effect, no ceiling effect, and 0 logit difference between participants and items
mean measure targets appropriately the recruited sample participants. The item and person
maps graphically show the targeting of persons compared to the measurement instrument.
Finally, we provide the score-to-measure tables to allow future users to turn the
questionnaires’ total scores into interval measures.
We used FACETS 3.84.0 and WINSTEPS 5.4.3.0 for the Rasch analysis (partial credit
model). We performed the statistics using the R (R version 4.2.3 “Shortstop Beagle”)
software. Type 1 error probability was set to 0.05 as customary in all analyses, but we
lowered this threshold for DIF to 0.01 because of multiple statistical testing [15,27].

2.7. Ethical Approval

The local ethics committee approved the study (Comitato Etico Milano Area 2,
215_2022bis), and we registered the protocol on clinicaltrials.gov (NCT05333757). This study
did not receive dedicated funding support. All participants gave written informed consent.

3. Results
At the time of data extraction, our database included 3254 adult patients with scoliosis or
other spinal deformities (2540 females, 714 males), fulfilling the inclusion criteria. From these,
we randomly selected 150 subjects (120 females, 30 males). For each group, we had 20 females
and five males diagnosed with scoliosis based on clinical and radiological assessment.
Table 1 reports the clinical features of the participants included in the current analysis.

Table 1. Participants’ clinical data.

Adults Adolescents
Males vs. females, N 30 vs. 120 10 vs. 40
Mean age (SD), years 49 (17.8) 16 (1.4)
Mean disease severity (SD), ◦ Cobb 46.2 (16.6) 24.7 (9)
Median TRACE score (IQR) 7 (4) 5 (3)
N: number of participants; SD: standard deviation; ◦ Cobb: angle of scoliosis curvature measured according to
Cobb; IQR: interquartile range; TRACE: trunk aesthetic clinical evaluation (ordinal score of back aesthetics ranging
from 1 to 12, with a high score marking a poor trunk aesthetic appearance).

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3.1. Rasch Analysis of ISYQOL International

All nine items of ISYQOL International had ordered categories and thresholds (Table A1
in Appendix B).
Regarding the fit to the model, infit and outfit MnSq were suitable for all the question-
naire’s items (Table 2).

Table 2. Calibration of items of ISYQOL International and their fit to the model.

Infit Outfit
Items Calibration SE
MnSq Z-Std MnSq Z-Std
1 (1), get worse −1.95 0.17 0.97 −0.30 0.99 0.00
2 (2), worried back pain −0.95 0.15 1.12 1.17 1.54 3.11
3 (3), big deal 1.76 0.16 1.00 0.00 0.95 −0.23
4 (4), worried not get better −0.13 0.14 1.01 0.10 1.08 0.61
5 (7), suffering 0.85 0.15 0.93 −0.64 0.84 −1.22
6 (8), appearance 1.10 0.15 0.82 −1.92 0.75 −1.81
7 (9), worried back problem −1.95 0.18 0.83 −1.68 0.75 −1.72
8 (11), bother to show 0.59 0.14 1.25 2.31 1.24 1.53
9 (12), worried visible 0.69 0.15 1.07 0.69 1.02 0.23
Items: the item number and a keyword summarising the item content; the item number of ISYQOL original is also
reported in brackets. Calibration: item calibration (i.e., item measure) expressed in logit. SE: standard error in the
item calibration (logit). Infit: inlier sensitive fit indices; outfit: outlier sensitive fit indices. MnSq: mean square
statistic; Z-std: z-standardised statistic.

The PCA of the model’s residuals highlighted that another dimension, in addition
to the one taken into account by the Rasch model, affects the questionnaire scores. The
eigenvalue of the first principal component was 2.55, a value which indicates that the
hidden dimension affects the score of three items at most.
Cluster 1, i.e., the cluster of items with a positive loading on the first principal com-
ponent, included items 6, 8, and 9 (8, 11, and 12 of ISYQOL original; Figure 1). Notably,
all these three items had a large (>0.60) loading. Cluster 3 (i.e., the items with negative
loading) included items 1, 2, and 7 (1, 2, and 9 of ISYQOL original).

Figure 1. ISYQOL International dimensionality. The principal component analysis (PCA) calculated
on the model’s residuals is provided for the ISYQOL International questionnaire. Panel (A): loadings
of the ISYQOL International items on the first principal component from the PCA. The items are
grouped into three clusters (cluster 1, 2, and 3). Cluster 2 (dark grey) items load low in absolute value
on the principal component. Their score is scarcely affected by the hidden variable flagged by this
component but mainly reflects the variable, i.e., disease burden, grasped by the Rasch model. On the
contrary, the score of cluster 1 items (black) is inflated by an additional hidden variable, while that
of cluster 3 items (light grey) is reduced. Panel (B): participants are measured with cluster 1, 2, and
3 items, and their mean measure is compared (black dots). Vertical continuous line: participants’ mean
measures from the total ISYQOL International. Vertical dashed lines: participants’ mean measures
from the total ISYQOL International ± 0.5 logit. On average, the participants’ measures from the
three clusters of items are only slightly different from each other and minimally different from the
participants’ measures from the full ISYQOL International. In particular, the mean difference between
the clusters and the total questionnaire measures is well below 0.5 logits. Even if an additional
unwanted variable contaminates the scores of cluster 1 and 3 items, this variable causes a negligible

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measurement artefact. Extreme persons, i.e., those obtaining the maximum or minimum questionnaire
total score, whose real measure is unknown, have not been considered in this analysis.

ANOVA comparing the persons’ measures from cluster 1, 2, and 3 items was not
significant (F2,368 = 1.09; p = 0.337), indicating that on average, clusters 1 and 3, i.e., the
clusters of items more severely affected by the first principal component hidden variable,
measure the same as cluster 2 items, i.e., the items prominently reflecting the variable
grasped by the model of Rasch.
Table 3 reports the results of the DIF analysis.

Table 3. Age-related differential item functioning of the ISYQOL International and SRS-22 questionnaires.

Item Group Obs − Exp Bias SE p Value

ISYQOL International
8 (11), bother to show Adolescents 0.19 0.83 0.28 0.006
SRS-22
3, nervous person Older 0.31 0.61 0.20 0.003
4, back shape Adolescents −0.46 0.68 0.17 0.000
8, back pain at rest Older 0.36 0.51 0.17 0.004
12, around the house Adolescents 0.39 1.19 0.35 0.002
Item: item number and its keyword; the item number of ISYQOL original is also provided in brackets. Group:
participants group for which the item’s calibration differs from the primary analysis (e.g., the calibration of
ISYQOL International item 8 is different in adolescents than in the primary analysis). Obs-Exp: artefact in the item
score caused by differential item functioning (DIF) and expressed as the difference between the observed (Obs)
and expected (Exp) score. The expected score is calculated given the item’s calibration from the primary analysis.
For example, DIF for age inflates by 0.19 the score of adolescents on ISYQOL International item 8 (i.e., their score
on this item is 0.19 points higher than it should be). Bias: absolute value difference, expressed in logits, between
the item’s calibration from the primary analysis and the participants’ group. SE: standard error (logit) of the bias.
p value: type 1 error probability of the t-test with the null hypothesis: “item’s calibrations in group and primary
analysis are not different from each other”. For both the ISYQOL International (upper row) and the revised SRS-22
(lower rows), only the items with DIF > 0.5 logit with p < 0.01 are reported. No DIF was found for gender.

One item only (item 8, corresponding to item 11 in the ISYQOL original) was affected
by DIF for age.
In detail, item 8’s calibration was lower in adolescents than in the primary analysis,
including participants of all ages (calibration difference = 0.83 logits, p = 0.006).
The age-related DIF for item 8 indicates that adolescents are more likely to be bothered
than young, middle-aged, and older people by showing their physical appearance despite
the same overall burden of disease level.
Even if large at the item level and statistically significant, the age-related DIF of item 8
caused a minor artefact on the ISYQOL total score (and hence on the ISYQOL measures).
On average, adolescents scored more than expected on item 8. However, the difference
between the observed score on item 8 (biased since inflated by DIF) and the expected
score given the primary analysis was 0.19 (i.e., less than one-fifth of a point of the ISYQOL
International total score).
We found no DIF for gender.
The ISYQOL International’s reliability (model, sample reliability, extremes included)
was 0.88, which allows for distinguishing 3.91 strata. The questionnaire targeting was
satisfactory, as indicated by a participant’s mean measure of 0.27 logits (SD = 2.52 logits).
Regarding the ceiling and floor effect, ten participants (out of 200, i.e., 5%) obtained
the maximum score and five (i.e., 2.5%) the minimum.
Figure 2 shows the item and person maps of ISYQOL International. Table 4 provides
the ISYQOL International score-to-measure conversion table.

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ȱ
Figure 2. ISYQOL International maps. Maps of persons (A), thresholds (B), and items (C) of the
ISYQOL International questionnaire (spine domain). PCP: participants; n: number of; THR: Andrich’s
thresholds. X-axis: line of the construct (i.e., the disease burden continuum) measured in logits. The
disease burden increases from left to right. ISYQOL logit measures are measures of disease burden:
the higher the logit measure, the more the disease burden. Rightmost persons on the disease burden
line (A) suffer a high disease burden. The rightmost items (C) flag a high disease burden: only
persons suffering a high disease burden will affirm the content of these items. In (C), the Y-axis
reports the ISYQOL International item number. Labels in plot (C) are keywords recollecting the item
content. The dot position on the X-axis returns the item measures, called here “item calibration”.
Vertical dashed segment: items mean calibration, set to 0 logits, as customary.

Table 4. Score-to-measure conversion table of ISYQOL International.

Burden of Disease HRQOL

Score SE, SE,
Measure, Logit Measure, %
Logit %
0 −6.44 1.95 100.0 16.2
1 −4.89 1.24 87.1 10.3
2 −3.64 1.03 76.7 8.6
3 −2.73 0.89 69.1 7.4
4 −2.04 0.78 63.3 6.5
5 −1.49 0.71 58.8 5.9
6 −1.03 0.66 54.9 5.5
7 −0.61 0.63 51.4 5.3
8 −0.22 0.62 48.1 5.2
9 0.16 0.61 45.0 5.1

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Table 4. Cont.

Burden of Disease HRQOL

Score SE, SE,
Measure, Logit Measure, %
Logit %
10 0.54 0.61 41.9 5.1
11 0.92 0.62 38.7 5.2
12 1.32 0.64 35.4 5.3
13 1.73 0.66 31.9 5.5
14 2.19 0.69 28.1 5.8
15 2.70 0.74 23.9 6.2
16 3.32 0.84 18.7 7.0
17 4.22 1.10 11.2 9.1
18 5.56 1.88 0.0 15.7
Score: ISYQOL International (spine health domain) total ordinal score. Measure, logit: interval measures of disease
burden expressed in logits, i.e., the measurement unit of the Rasch analysis. Measure, %: interval measures reported
on a user-friendly scale ranging from 0 to 100%, with 100% indicating full health-related quality of life (i.e., no
disease burden). SE: standard error. Note that the higher the ISYQOL International total score, the higher the
problems caused by the back condition to the patient (i.e., the higher the disease burden). The relationship between
logit measures and ordinal scores is monotonic. Therefore, the higher the logit measure, the more the disease
burden. Originally, ISYQOL was conceptualized as an HRQOL measure rather than a disease burden measure. For
this reason, measure %, which is reversed compared to the total score and the logit measure, is also reported.

3.2. Rasch Analysis of SRS-22

On the first analysis run, 11 items had disordered categories. One possible reason
was that the respondents seldom selected the lower categories. As a result, the accuracy of
estimating the categories’ parameters was poor.
We rearranged items 7, 8, 9, 13, 17, and 20 by collapsing the original categories 1 and
2 into the new category 1. For items 5, 11, 15, 18, and 22, it was necessary to collapse
categories 1, 2, and 3. Note that after this procedure, SRS-22 consisted of a mixture of items
scored on five (11 items), four (6 items), and three (5 items) categories.
The collapsing procedure efficiently ordered all the items’ categories (Table A2 in
Appendix B)
However, modal thresholds were disordered in seven items (7, 9, 12, 15, 16, 17, and 19).
On a subsequent analysis run, item 15 did not fit the model because of a large and
significant outfit (MnSq = 2.97; Z-Std = 3.30). On a new run in which item 15 was dropped
from the questionnaire, all 21 items properly fit the model (Table 5). The analysis continues
assessing the measurement properties of this revised version of the SRS-22.

Table 5. Calibration of items of the revised SRS-22 and their fit to the model.

Infit Outfit
Items Calibration SE
MnSq Z-Std MnSq Z-Std
1, pain six months −0.28 0.09 0.69 −3.72 0.66 −3.67
2, pain last month −0.15 0.09 0.75 −2.83 0.71 −3.06
3, nervous person 0.40 0.10 1.14 1.41 1.21 2.02
4, back shape 0.70 0.09 1.09 0.96 1.10 1.00
5, activity level −0.24 0.12 0.87 −1.46 0.85 −1.13
6, look in clothes 0.32 0.10 1.04 0.41 1.04 0.45
7, down in the dumps −0.71 0.10 0.97 −0.27 1.13 0.68
8, back pain at rest 0.30 0.09 1.42 4.07 1.52 3.90
9, work/school −0.41 0.09 1.09 0.79 1.08 0.44
10, trunk appearance 1.19 0.10 1.00 0.03 1.01 0.10
11, pain medications −2.13 0.18 0.96 −0.24 1.00 0.06
12, around the house −0.19 0.08 0.74 −2.73 0.81 −1.30
13, calm and peaceful 0.72 0.11 1.17 1.73 1.18 1.72
14, personal relationships −0.72 0.09 0.80 −1.82 0.72 −1.63

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Table 5. Cont.

Infit Outfit
Items Calibration SE
MnSq Z-Std MnSq Z-Std
16, downhearted and blue −0.52 0.09 1.09 0.83 1.08 0.64
17, days off −0.99 0.12 1.35 1.67 1.80 1.21
18, going out −0.61 0.13 0.89 −1.10 0.98 −0.07
19, feel attractive 1.29 0.09 0.97 −0.22 0.91 −0.84
20, happy person 0.67 0.11 1.03 0.37 1.05 0.48
21, satisfied with results 0.52 0.09 0.95 −0.52 0.93 −0.65
22, same management again 0.84 0.11 1.20 2.26 1.24 2.01
Same abbreviations as Table 2. SRS-22 item 15 is not reported because of outfit values beyond the tolerance limits.
The item numbering of the original SRS-22 was kept. Remember that the categories of the original SRS-22 items
have been extensively rearranged.

The PCA of the residuals highlighted two hidden dimensions, as indicated by the
eigenvalue of the first principal component (3.45) and that of the second (2.72).
Items 1, 2, and 12 were the three items with the largest loading of cluster 1 (Figure 3).
Items 4, 10, and 19 were the three with the largest negative loading (i.e., cluster 3 items with
the largest loading). Regarding the second principal component, the three cluster 1 items
were items 7, 13, and 16. The three most significant cluster 3 items were items 10, 19, and 21.

Figure 3. SRS-22 dimensionality. The principal component analysis (PCA) of the SRS-22 questionnaire
(revised version) highlighted two principal components, indicating that the score of some SRS-22
items were affected by two hidden variables in addition to the Rasch dimension. Same symbols and
abbreviations as Figure 1. Upper graphs in panels (A,B) report the analysis for the first principal
component. The lower graphs report the clusters on the second principal component. The revised
SRS-22 consists of 21 items. Here, are only the three cluster 1 items with the largest positive loadings,
the three cluster 3 items with the largest negative loadings, and the three cluster 2 items with the
most negligible loading.

Despite the presence of two additional dimensions, person measures from the three
items clusters were not significantly different from each other (contrasts on the first prin-
cipal component: F2,396 = 1.57; p = 0.209; contrasts on the second principal component:
F2,396 = 0.60; p = 0.549).
Four items (i.e., items 3, 4, 8, and 12) were affected by DIF for age (Table 3).
Item 3’s calibration was significantly lower when calculated in the older adults group
than when we inputted the total participants’ sample into the analysis. (i.e., item 3’s
calibration was lower in older persons than in middle-aged, young adults, and adolescents).

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We found the same pattern for item 8. Item 4’s calibration was higher, and item 12’s was
lower in adolescents.
Due to these differences in the items’ calibrations, the older adults observed scores
on items 3 and 8 was larger than expected. Adolescents’ scores on item 4 were lower than
predicted, while on item 12 were higher.
However, when we consider the artefact they cause in the SRS-22 total score, the biases
of items 4 and 12 have opposite signs (the first decreases and the second increases the item’s
score), thus compensating each other. The bias of items 3 and 8 inflates the SRS-22 total
score by 0.31 and 0.36 points (i.e., 0.67 points when considered together) in older persons.
Similarly to ISYQOL International, DIF is present, but its consequences on the measures
derived from the total questionnaire score seem modest.
We found no DIF for gender.
The reliability of the modified version of the SRS-22 questionnaire was 0.91, and the
number of strata was 4.59.
Only one respondent obtained the SRS-22 maximum score. However, the participants’
mean measure was 0.86 logits (SD = 1.18 logits), flagging poor targeting of the SRS-22
questionnaire in this sample (Figure 4).

ȱ
Figure 4. Revised SRS-22 maps. Same abbreviations as Figure 1. SRS-22 logit measures are measures
of quality of life. So, the higher the logit measure, the higher the quality of life. People experiencing a
full quality of life are on the right of the continuum, and quality of life decreases from right to left.
Note that the persons map (A) histogram is displaced to the right (e.g., the distribution mode is about
0.75 logits). This indicates that persons score high on the questionnaire and that the SRS-22 items are

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too easy to endorse for the participants’ sample recruited here. The thresholds histogram (B) shows
several thresholds with overlapping calibrations between −1 and 0 logits. While many thresholds (or
items) within the same construct range increase the measurement precision, it also points out some
redundancy in the questionnaire. (C) items map.

We provide the score-to-measure table of the revised SRS-22 version in Table 6.

Table 6. Score-to-measure conversion table of the revised SRS-22.

HRQOL HRQOL
Score Measure, SE, SE,
Measure, %
Logit Logit %
21 −5.99 1.85 0.0 14.7
22 −4.73 1.04 10.1 8.3
23 −3.96 0.75 16.2 6.0
24 −3.49 0.63 19.9 5.0
25 −3.15 0.55 22.7 4.4
26 −2.88 0.50 24.8 4.0
27 −2.65 0.46 26.6 3.6
28 −2.46 0.42 28.2 3.4
29 −2.29 0.40 29.5 3.2
30 −2.14 0.37 30.7 3.0
31 −2.01 0.36 31.7 2.8
32 −1.89 0.34 32.7 2.7
33 −1.78 0.33 33.6 2.6
34 −1.67 0.32 34.4 2.5
35 −1.58 0.31 35.2 2.4
36 −1.49 0.30 35.9 2.4
37 −1.40 0.29 36.6 2.3
38 −1.32 0.28 37.2 2.3
39 −1.24 0.28 37.8 2.2
40 −1.17 0.27 38.4 2.2
41 −1.10 0.27 39.0 2.1
42 −1.03 0.26 39.6 2.1
43 −0.96 0.26 40.1 2.1
44 −0.89 0.26 40.7 2.1
45 −0.82 0.26 41.2 2.1
46 −0.76 0.26 41.7 2.0
47 −0.69 0.25 42.2 2.0
48 −0.63 0.25 42.7 2.0
49 −0.56 0.25 43.3 2.0
50 −0.50 0.25 43.8 2.0
51 −0.44 0.25 44.3 2.0
52 −0.37 0.25 44.8 2.0
53 −0.31 0.26 45.3 2.0
54 −0.24 0.26 45.8 2.0

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Table 6. Cont.

HRQOL HRQOL
Score Measure, SE, SE,
Measure, %
Logit Logit %
55 −0.18 0.26 46.4 2.1
56 −0.11 0.26 46.9 2.1
57 −0.04 0.26 47.4 2.1
58 0.03 0.26 48.0 2.1
59 0.10 0.26 48.5 2.1
60 0.17 0.27 49.1 2.1
61 0.24 0.27 49.7 2.2
62 0.31 0.27 50.2 2.2
63 0.39 0.28 50.8 2.2
64 0.47 0.28 51.5 2.2
65 0.54 0.28 52.1 2.3
66 0.63 0.29 52.7 2.3
67 0.71 0.29 53.4 2.3
68 0.80 0.30 54.1 2.4
69 0.89 0.30 54.8 2.4
70 0.98 0.31 55.6 2.5
71 1.08 0.32 56.4 2.5
72 1.18 0.32 57.2 2.6
73 1.29 0.33 58.0 2.6
74 1.40 0.34 58.9 2.7
75 1.52 0.35 59.9 2.8
76 1.65 0.36 60.9 2.9
77 1.78 0.37 61.9 2.9
78 1.92 0.38 63.0 3.0
79 2.07 0.39 64.2 3.1
80 2.22 0.40 65.5 3.2
81 2.39 0.41 66.8 3.3
82 2.57 0.43 68.2 3.4
83 2.76 0.44 69.7 3.5
84 2.96 0.46 71.4 3.7
85 3.19 0.49 73.2 3.9
86 3.44 0.52 75.2 4.1
87 3.73 0.56 77.5 4.5
88 4.09 0.63 80.3 5.0
89 4.56 0.75 84.1 6.0
90 5.31 1.03 90.1 8.2
91 6.56 1.84 100.0 14.7
Same abbreviations as Table 4. SRS-22 logit and percentage measures are quality-of-life measures: the higher the
measure, the better the patient. After collection, SRS-22 item scores are rearranged so that the higher the score for
each item, the better the quality of life.

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4. Discussion
Spinal deformities can negatively impact a patient’s quality of life during adulthood.
To monitor the changes over time, clinicians need specific tools to picture the patient’s
pain, activity limitations, and participation restrictions. Many validated and reliable tools
are available for patients with chronic LBP [28]. They can also help in the case of spinal
deformities but could lack some specificity. From a psychometrics perspective, their content
validity is poor. For example, some items included in the Oswestry Disability Index (ODI),
such as rest quality and travelling, are not specific for spinal deformities. In a recent study
about bracing, despite the significant improvements in pain, the ODI failed to show clinically
significant improvements [29]. In a sample of surgically treated patients, the SRS self-image
domain demonstrated higher responsiveness to change, followed by SRS total, then SRS
pain, and then ODI [7]. Unfortunately, it is unclear whether it was a limit of the ODI, or an
issue related to the too-small clinical changes of patients. These findings and limits suggest
the need for developing specific tools. The SRS-22 was explicitly designed for adolescent
scoliosis patients managed in a surgical setting. For those treated conservatively, they
showed some limits and mainly a ceiling effect [12]. Many authors and clinicians use the
SRS-22 also in adults even though young patients were its original target, and some limits
have already been reported [10]. The SRS-22 remains the most widely used questionnaire
in adults with spinal deformities. Nevertheless, the challenges with the currently accepted
standard questionnaire (SRS-22) for HRQOL assessments in scoliosis are detailed in the
literature and application of the SRS-22 in the adult population with scoliotic deformities
has been debated [30]. Currently, there is no gold standard that is reliable and valid for the
complexity of the ‘patient’s perception’ on how their deformity impacts their life. Recently,
we developed a new tool, the ISYQOL, to measure conservatively managed patients during
growth appropriately, but no data are available for adults. The current one was the first study
to compare the properties of the ISYQOL to the SRS-22 in adults attending a rehabilitation
centre specialized in the conservative treatment of spinal deformities.
Regarding the Rasch analysis, the original SRS-22 questionnaire, but not ISYQOL
International, failed to meet the two basic assumptions of the analysis: the assumption of
ordered categories and data-model fit.
Several SRS-22 items had disordered categories and thresholds, and disordered thresh-
olds remain even after rearranging the categories so that their average measure is ordered.
In addition, item 15 of SRS-22 does not fit the model. Therefore, in the fundamental mea-
surement framework [11,31], the SRS-22 should not be used in its original form to measure
the disease burden in adults with spinal deformities.
Despite rearranging the SRS-22 to comply with the ordered categories and data-model
fit assumptions, multidimensionality still affects it, and DIF corrupts several items for age
and gender. ISYQOL International suffers similar issues in this respect. However, regarding
multidimensionality, SRS-22’s measures of HRQOL are disturbed by two additional un-
known variables, while those from ISYQOL International are disturbed by one. The SRS-22
is tridimensional, while ISYQOL International is bidimensional: considering that accurate
measures are unidimensional [11], we can assume the latter to be better than the former.
Regarding DIF, DIF for age afflicts more SRS-22 than ISYQOL items.
From a measurement theory perspective, multidimensionality and DIF are serious
flaws. However, the total questionnaire score and the measures extracted with the Rasch
analysis from these scores are robust to some DIF and multidimensionality [32]. If a ques-
tionnaire demonstrates this measure’s robustness, we can safely use it despite these flaws.
Based on our findings, the ISYQOL International and the modified SRS-22 version can mea-
sure the disease burden despite the DIF and multidimensionality, since we experimentally
found these flaws are negligible. However, the artefacts caused by DIF and multidimen-
sionality would likely be non-negligible if single or groups of items were selected from the
questionnaire and used for measuring, a frequently used practice for SRS-22 [7].
ISYQOL International has two additional strengths: it is shorter and more straightfor-
ward than the SRS-22 and better targeted than SRS-22. About this last point, the average

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SRS-22 measure is larger than 0 logits, indicating that several SRS-22 items investigate a
(low) range of HRQOL, which the patients included here do not experience. SRS-22 is not
perfectly tuned to measure patients like those recruited here.
On the contrary, SRS-22’s reliability is better than that of ISYQOL International, a
finding which results from its large number of categories times items. However, the
modest improvement in the reliability of SRS-22 comes at the expense of a more marked
increase in the number of categories and items (91 for SRS-22 and 27 for the ISQYOL
International—spine domain).
We already assessed the measurement properties of the SRS-22 with the Rasch analysis [12],
and our previous study also pointed out different problems. However, in the current work, a
more liberal analysis has been conducted, so the SRS-22 flaws seem less severe. Nevertheless,
even if adherence to the analysis requirements is relaxed as much as possible, some significant
drawbacks remain, such as disordered categories and a misfitting item.
Another reason for the different results of the current and our former work is that the
participants recruited here were mostly adults. At the same time, previously, we studied SRS-
22 functioning in children and adolescents. The DIF analysis highlights that, in most cases,
adolescents usually understand several SRS-22 items differently from adults. Hence, SRS-22
could function differently in young people than adults, but further research is needed.

Study Limitations and Further Developments

The SRS-22 and ISYQOL International questionnaires demonstrated multidimension-
ality, suggesting they measure multiple HRQOL aspects. It has been empirically shown
here that this multidimensionality is unlikely to harm. However, multidimensionality
is always a measurement threat strictly, making the questionnaires’ interpretation more
challenging. In this regard, the additional hidden variable in ISYQOL International’s scores
and the two hidden variables in the SRS-22 remain to be discovered.
The same reasoning applies to the results of the DIF analysis (to note, DIF is simply
another form of multidimensionality). The study found that some questionnaire items
functioned differently in individuals of different ages. Furthermore, in this case it is shown
that the measurement artefact caused by DIF is negligible. However, in strict metrological
terms, this response bias indicates that the questionnaires do not perform consistently
across different age groups.
ISYQOL is a relatively new instrument, and studies are needed to assess it further. Re-
cently, ISYQOL has been translated into different languages and tested in different cultures
in young persons with scoliosis [15]. There is a need to compare ISYQOL International
and SRS-22 in adult patients from different countries and cultures as well. We could also
test ISYQOL’s properties in patients who underwent spine surgery and compare it to other
quality-of-life measures in addition to SRS-22. Finally, ISYQOL International has no items
assessing pain, which can be a significant complaint adults make [3]. If this is an issue
regarding ISQOL International’s face validity when used to evaluate the scoliosis burden
of disease in adults, it remains to be investigated.

5. Conclusions
Scoliosis treatment cannot be restricted solely to correcting the curvature, but it should
also assess and monitor patients’ satisfaction, psychological issues, and HRQOL over time.
There is a need for a proper tool that allows clinicians to evaluate the impact of spinal
deformities in adulthood. The results of the present work indicate that the ISYQOL spine
health subscale can be administered in a clinical setting to evaluate HRQOL in adults with
scoliosis. SRS-22, in its original form, showed poor construct validity in the Rasch analysis
measurement framework. While the revised SRS-22 has improved metrological features,
ISYQOL International is better regarding dimensionality and differential item functioning.
In addition, ISYQOL International is also considerably shorter, more straightforward, and
better targeted to measure the disease burden in adults with non-surgical scoliosis.

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Author Contributions: Conceptualization, F.Z.; methodology, A.C. and S.S.; formal analysis, A.C. and
S.S.; interpretation of results: F.Z., S.N. and S.D.; writing—original draft preparation, I.F.; writing—review
and editing, all authors. All authors have read and agreed to the published version of the manuscript.
Funding: This research received no external funding.
Institutional Review Board Statement: The study was conducted in accordance with the Declaration
of Helsinki, and approved by the Ethics Committee Comitato Etico Milano Area 2 (parere 215_2022bis,
approved 29 March 2022).
Informed Consent Statement: Informed consent was obtained from all subjects involved in the study.
Data Availability Statement: The data presented in this study will be available on Zenodo upon
acceptance of the paper.
Acknowledgments: This study was supported and funded by the Italian Ministry of Health-Ricerca
Corrente (2022).
Conflicts of Interest: S.N owns stock in ISICO. I.F. is related to S.N. All other authors have no conflict
to declare.

Appendix A. Methods: The Rasch Analysis of the SRS-22 and ISYQOL

International Questionnaires
The Rasch analysis run in the current study has been briefly mentioned in the main
text and is detailed in the present appendix. The following steps have been followed to
assess the construct validity of the SRS-22 and ISYQOL International questionnaires.
1. Categories’ functioning
First, the categories’ functioning has been evaluated by assessing their order and the
order of the modal thresholds.
The Rasch analysis assumes that the greater the measured variable, the higher the
item numeral chosen by the respondent.
In the current study, regarding ISYQOL International, assessing the category order
means verifying that the average burden of disease measure of the participants scoring 2
on an item is higher than that of those scoring 1 on the same item. In turn, those scoring 1
measure higher than those scoring 0. If this monotonic relationship between the items’
numerals and the average sample measures holds for all the questionnaire’s items, the
questionnaire’s category structure can be considered to work as intended. Regarding SRS-
22, categories are ordered if those participants choosing category 5 on an item enjoy, on
average, a lower burden of disease than those scoring 4 (and so on).
In addition to the category order, the order of the modal thresholds is also assessed
as a complementary analysis. According to some scholars [23], ordered categories and
thresholds are more robust evidence that the items category structure works appropriately.
When applied to ISYQOL International, “ordered thresholds” means that there exists a
range of disease burden values for which category 0 is most likely chosen from respondents.
Adjoining this range is the range of values for which the modal category is category 1
and, finally, the range of disease burden for which category 2 is the modal one. The same
reasoning applies to SRS-22.
2. Fit to the model
Measures can be extracted from the questionnaire’s scores if categories are ordered,
and data fit the model of Rasch. To date, the original model of Rasch for the analysis of
dichotomous items is complemented by additional models, such as the partial credit model,
the one used for the current research, allowing the analysis of polytomous items.
The mean square (MnSq) and the z-standardised (Z-Std) statistics quantify the de-
parture of the observed data from the model’s prediction and the probability that this
departure is due to chance, respectively.
Two versions of the MnSq and Z-Std statistics are usually considered: the “outfit”,
sensitive to outliers (which is obtained from the chi-squared statistics), and the “infit”.

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A large and significant infit MnSq indicates that items whose difficulty is well targeted
on the respondents’ ability do not work according to the model prescription. A large infit
suggests a more severe item malfunctioning.
Here, an item is considered to “misfit”, i.e., not fitting the model adequately, if
outfit MnSq > 2.0 and absolute outfit Z-Std > 1.96, or
infit MnSq > 1.5 and absolute infit Z-Std > 1.96.
Misfitting items are often dropped from the questionnaire.
As mentioned above, once the data are demonstrated to fit the model, questionnaire
scores can be turned into measures on an interval scale. The logit is the measurement unit
of these measures.
3. Dimensionality
Measures are unidimensional, i.e., reflect the amount of a single variable. However, in
practice, any measurement is affected by some multidimensionality. Therefore, in addition
to assessing if a measure is multidimensional, it is crucial to determine the amount of
dimensionality and if multidimensionality is so extensive as to distort measures.
In the Rasch framework, multidimensionality is indicated by principal components
with an eigenvalue >2 based on a principal component analysis (PCA) calculated on the
model’s residuals.
The idea behind this approach is straightforward: if questionnaires’ scores are unidi-
mensional, once the Rasch dimension is “peeled off” from the data, randomness remains in
the residuals (i.e., the residuals are entirely uncorrelated). On the contrary, correlation among
residuals indicates that a hidden, additional variable drives together the items’ scores.
The PCA is simply a statistical technique that efficiently highlights the correlation
pattern among residuals.
In the case of multidimensionality being found, the following approach is used here
to evaluate if this multidimensionality harms the measurements.
Items are split into three clusters according to their loading on the principal component
with eigenvalue >2: items belonging to cluster 1 have a large positive loading, and those
belonging to cluster 3 have a large and negative loading. Finally, cluster 2 items have a low
load on the principal component.
Therefore, the score of cluster 1 and 3 items depends on the quantity of the variable
grasped by the Rasch model and the quantity of the variable highlighted by the principal
component. The score of cluster 2 depends instead on the Rasch variable only.
Moreover, the score of cluster 1 items is inflated by the principal component variable
while that of cluster 3 items is decreased, where “increased” and “decreased” are compared
to what is predicted by the Rasch model.
Persons are measured with the three clusters, and the three sets of measures are
compared with ANOVA (here calculated on linear mixed-effects models).
If persons’ measures from cluster 1 and cluster 3 are comparable to, i.e., not signifi-
cantly different from those from cluster 2 (i.e., those measures reflecting only the variable
grasped by the model of Rasch), then the inflation/deflation of the items’ scores caused by
the hidden variable highlighted from the principal component is not strong enough to cause
a severe measurement artefact. In a few words, despite multidimensionality, the Rasch
variable still mainly drives the items’ scores (despite multidimensionality, the measures
from multidimensional items are still comparable to those from unidimensional ones).
Only non-extreme person measures are used for this analysis to improve the accu-
racy of the analysis (measures are approximated for persons totalling the questionnaire
maximum or minimum total score).
4. Differential Item Functioning
Differential item functioning (DIF), also called item bias, indicates that an item does
not work the same in different groups of respondents.

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A prominent feature of measures is that they depend only on the measured quantity
and are not affected by other features of the measured object. An example from the physical
world will clarify this aspect.
Say we have 1 kg of carrots and 1 kg of potatoes. We expect that if a scales is used to
measure the mass of carrots and potatoes, the scales reading will be the same (1 kg) when
both vegetables are tested.
Say instead that the scales returns 1.3 kg for the (1 kg) of carrots and 0.8 kg for the
(1 kg) of potatoes. We would conclude that there is something wrong with the scales. Is the
scales measuring the mass and something else (maybe the volume of the vegetable)? Is the
scales broken?
The DIF assessment evaluates if an item (which corresponds to the scales of the
previous example) returns the same measures of persons (vegetables, in the example)
belonging to different groups (e.g., carrots and potatoes). Here, testing DIF is testing if
measures from an item of individuals with the same burden of disease level but belonging
to different groups (e.g., adolescents vs. old persons) are the same.
Since the study aims to assess if SRS-22 and ISYQOL are suitable to quantify the burden
of disease in adults and older people, the current analysis focussed on the DIF for age. The
participants’ sample was split into: adolescents (from 14 to 18 years), young adults (from 20
to 39 years), middle-aged adults (from 40 to 59 years), and older adults (from 60 to 79 years).
As a complementary analysis, DIF for gender (males vs. females) was also evaluated.
The DIF of SRS-22 and ISYQOL International items is tested here following Linacre [25].
The observed scores for an item in a group of respondents (say older adults) are
compared to their expected scores for that item given the items’ calibration from the
primary analysis, the analysis including the whole participants’ sample (i.e., adolescents,
young, middle-aged, and older people).
Now, imagine that older adults scored more than expected on item i. Item i is thus
easier to endorse in older adults than in the complete participants’ sample and easier
to endorse than in the participants of the remaining subsets. In other words, the item’s
calibration is lower for older adults than for the participants of the other classes.
Item i is considered corrupted by DIF if the difference between the two calibrations is
large (i.e., >0.5 logits) and significant (i.e., p < 0.01, see below).
Say DIF is found for some items and grouping variables (i.e., age or gender here). Similar
to multidimensionality, what is essential is to assess if DIF causes such a large measurement
distortion to produce an artefact in the persons’ measures from the questionnaire total score.
The consequences of DIF (i.e., the malfunctioning of some items) on the measures
from the questionnaire’s total score can be just assessed by comparing the observed and
expected scores.
Imagine a questionnaire, with each item scored in four categories. Now, consider
two different scenarios in which DIF corrupts item k. In the first scenario, the average
observed score by a class of respondents is 2.1 points higher than expected. In the second,
the difference between the observed and the expected score is 0.14. In the first case, DIF
causes a two-point artefact in the total questionnaire score (and thus on the respondents’
measures). In the second, the impact of DIF on the total score are much more negligible
(the total score is inflated by just 0.14).
By comparing the observed and expected scores, it is thus easy to understand the
artefact caused by DIF at the questionnaire’s total score level.
This way of analysing DIF clearly makes the questionnaire’s total score (and thus the
questionnaire measures) central. The idea behind this is all about answering the question:
are item calibrations from the main analysis (biased if there is DIF) a good proxy of the
exact calibration which would be obtained in the specific group of participants?
Because of multiple statistical testing, the type 1 error probability was lowered to 0.01
for the DIF significance analysis [27].

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5. Targeting and reliability

High-quality measures have high reliability, meaning the measurement error is low
compared to the measures’ total variance. High reliability implies that several levels of the
measured variable can be distinguished at a single subject level.
In the current work, ISYQOL International’s and SRS-22’s reliability is reported as
“Rasch persons’ reliability”, a reliability index similar to Cronbach’s alpha from the CTT.
From this reliability index, the number of strata is calculated, i.e., the number of significantly
different levels of the burden of disease a person can progress through.
For example, with a questionnaire or a scale with four strata, it is possible to follow
a patient’s modification of their clinical condition from severe to moderate, mild, and
eventually minimal. When the patient changes stratum, their clinical condition is different
in a statistically significant way (see Supplementary Materials 1 in [26]).
Finally, floor and ceiling effects are also calculated as the percentage of respondents
obtaining the minimum and maximum total questionnaire scores, respectively. The size of
the difference between the persons and the items measures complements this information.
A questionnaire with no floor effect, no ceiling effect, and 0 logit difference between
participants and items mean measure is appropriately targeted to the recruited sample
participants. To take an analogy from the physical world, a questionnaire with these
features is like a ruler of the proper length for measuring the object of interest (e.g., the
height of a chair vs. the length of a car).

Appendix B. Supplementary Results

Table A1. Category and threshold orders of the ISYQOL International (spine domain).

Average Andrich Threshold

Item Score Count Used
Measure Calibration SE
0 9 −1.36 - -
1, get worse 1 88 1.13 −2.27 0.39
2 88 3.45 2.27 0.19
0 28 −0.91 - -
2, worried back pain 1 77 0.30 −1.49 0.26
2 80 2.60 1.49 0.20
0 89 −3.03 - -
3, big deal 1 77 −0.50 −1.64 0.20
2 19 0.71 1.64 0.29
0 47 −1.82 - -
4, worried not get better 1 76 0.21 −1.30 0.22
2 62 2.01 1.30 0.21
0 65 −2.54 - -
5, suffering 1 86 −0.17 −1.61 0.20
2 34 1.57 1.61 0.24
0 71 −2.66 - -
6, appearance 1 85 −0.41 −1.64 0.20
2 29 1.76 1.64 0.25
0 6 −0.65 - -
7, worried back problem 1 106 1.08 −2.84 0.46
2 73 3.85 2.84 0.20
0 67 −1.94 - -
8, bother to show 1 72 −0.29 −1.20 0.21
2 46 1.55 1.20 0.22
0 58 −2.35 - -
9, worried visible 1 92 −0.18 −1.74 0.21
2 35 1.60 1.74 0.24
Item: item number and a keyword briefly describing the item content. Score: item’s categories. Counts: number of
observations per category participating in the estimation (extreme scores are excluded). Average measure: the mean
measure of the participants scoring a specific category to an item, calculated from the item’s calibration. For example,
item 3 calibration is 1.76 logits. The mean measure of the participants scoring 1 on item 3 is 1.76 − 0.50 = 1.26 logits.
Andrich thresholds calibration: calibration (i.e., measure) of the Andrich (modal) thresholds. SE: standard error. All
nine ISYQOL International items had ordered categories and thresholds.

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Table A2. SRS-22 category and threshold orders.

Average Andrich Threshold

Item Score Count Used
Measure Calibration SE
1 3 −1.69 - -
2 37 0.08 −2.74 0.63
1, pain six months 3 50 0.53 0.13 0.21
4 56 1.44 0.88 0.18
5 53 2.21 1.73 0.19
1 6 −0.91 - -
2 26 −0.10 −1.78 0.46
2, pain last month 3 51 0.37 −0.42 0.22
4 60 1.15 0.65 0.18
5 56 2.06 1.56 0.19
1 4 −1.96 - -
2 46 −0.21 −3.19 0.55
3, nervous person 3 88 0.34 −0.67 0.19
4 45 1.09 1.34 0.18
5 16 1.47 2.51 0.30
1 18 −1.15 - -
2 36 −0.55 −1.54 0.28
4, back shape 3 77 0.07 −1.04 0.19
4 44 0.63 0.90 0.18
5 24 1.39 1.67 0.26
1 26 0.10 - -
5, activity level 2 63 0.40 −0.54 0.23
3 110 1.68 0.54 0.16
1 5 −0.89 - -
2 19 −0.67 −2.12 0.50
6, look in clothes 3 94 0.28 −1.69 0.24
4 65 1.02 0.97 0.17
5 16 1.73 2.85 0.29
1 8 0.20 - -
2 30 0.54 −1.00 0.40
7, down in the dumps
3 35 1.04 0.73 0.21
4 126 2.01 0.27 (*) 0.17
1 28 −0.30 - -
2 49 0.02 −0.86 0.23
8, back pain at rest
3 53 0.70 0.19 0.18
4 69 1.09 0.68 0.18
1 15 −0.07 - -
2 26 0.47 −0.43 0.31
9, work/school
3 37 0.77 0.30 0.21
4 120 1.73 0.12 (*) 0.17
1 13 −1.89 - -
2 56 −0.88 −2.73 0.31
10, trunk appearance 3 100 −0.20 −1.17 0.17
4 23 0.54 1.64 0.23
5 7 1.39 2.26 0.44
1 2 1.97 - -
11, pain medications 2 38 2.01 −1.25 0.77
3 159 3.20 1.25 0.19
1 11 −0.84 - -
2 20 −0.05 −0.82 0.35
12, around the house 3 42 0.41 −0.50 0.23
4 38 1.04 0.82 0.19
5 88 1.78 0.50 (*) 0.18
1 21 −0.89 - -
2 57 −0.32 −1.70 0.26
13, calm and peaceful
3 98 0.36 −0.56 0.17
4 23 1.04 2.26 0.25

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Table A2. Cont.

Average Andrich Threshold

Item Score Count Used
Measure Calibration SE
1 5 −0.38 - -
2 11 0.05 −0.78 0.52
14, personal relationships 3 26 0.67 −0.34 0.31
4 42 1.15 0.51 0.21
5 115 2.12 0.62 0.17
1 6 −0.43 - -
2 8 −0.05 −0.41 0.48
16, down hearted and blue 3 38 0.79 −1.16 (*) 0.32
4 55 1.15 0.53 0.19
5 92 1.95 1.05 0.17
1 10 0.31 - -
2 6 0.83 0.92 0.39
17, days off
3 7 1.52 0.75 (*) 0.32
4 176 1.95 −1.67 (*) 0.26
1 18 0.27 - -
18, going out 2 52 0.80 −0.45 0.27
3 129 1.87 0.45 0.17
1 26 −1.70 - -
2 25 −1.22 −1.31 0.24
19, feel attractive 3 104 −0.33 −2.18 (*) 0.19
4 37 0.14 0.99 0.20
5 7 1.81 2.51 0.43
1 15 −0.84 - -
2 65 −0.38 −2.16 0.29
20, happy person
3 100 0.40 −0.40 0.17
4 19 1.52 2.56 0.27
1 11 −1.09 - -
2 26 −0.62 −1.68 0.35
21, satisfied with results 3 76 −0.01 −1.32 0.21
4 63 0.83 0.57 0.17
5 18 1.68 2.43 0.28
1 67 −0.71 - -
22, same management again 2 64 0.10 −0.37 0.18
3 62 0.55 0.37 0.18
Same abbreviations as Table A1. Note that item 15 was removed because it did not fit the model. Note also that
the original item structure on five categories has been rearranged for ten items because of disordered categories.
Finally, despite ordered categories, six items have disordered Andrich thresholds (*).

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Clinical Medicine

Article
Vertebral Rotation in Functional Scoliosis Caused by
Limb-Length Inequality: Correlation between Rotation,
Limb Length Inequality, and Obliquity of the Sacral Shelf
Martina Marsiolo 1, *, Silvia Careri 1 , Diletta Bandinelli 1 , Renato Maria Toniolo 1
and Angelo Gabriele Aulisa 1,2

1 U.O.C. of Orthopaedics and Traumatology, Bambino Gesù Children’s Hospital, Istituto di Ricerca e Cura a
Carattere Sceintifico (IRCCS), 00165 Rome, Italy; [email protected] (S.C.);
[email protected] (D.B.); [email protected] (R.M.T.); [email protected] (A.G.A.)
2 Department of Human Sciences, Society and Health, University of Cassino and Southern Lazio,
03043 Cassino, Italy
* Correspondence: [email protected]; Tel.: +39-3066-8594-873

Abstract: Background: Scoliosis is a structured rotatory deformity of the spine defined as >10◦ Cobb.
Functional scoliosis (FS) is a curve < 10◦ Cobb, which is non-rotational and correctable. FS is often
secondary to leg length inequality (LLI). To observe vertebral rotation (VR) in functional scoliosis due
to LLI, one must demonstrate a correlation between LLI, sacral shelf inclination (SSI), and VR and
discover a predictive value of LLI capable of inducing rotation. Methods: We studied 89 patients with
dorso-lumbar or lumbar curves < 15◦ Cobb and radiographs of the spine and pelvis. We measured
LLI, SSI, and VR. The patients were divided into VR and without rotation (WVR) groups. Statistical
analysis was performed. Results: The mean LLI value was 6.5 ± 4.59 mm, and the mean SSI was
2.8 ± 2.53 mm. The mean value of LLI was 5.2 ± 4.87 mm in the WVR group and 7.4 ± 4.18 mm in the
VR group. The mean SSI value for WVR was 1.4 ± 2.00 and that for VR was 3.9 ± 2.39. For each mm
of LLI, it was possible to predict 0.12◦ of rotation. LLI ±5 mm increased the probability of rotation
(R2.08 p < 0.0016), while this was ±2 mm for SSI (R2 0.22 p < 0.01). Each mm of LLI corresponded to
0.3 mm of SSI (R2 0.29, p < 0.01). Conclusions: FS secondary to LLI can cause VR, and 5 mm of LLI
can cause SSI and rotation.
Citation: Marsiolo, M.; Careri, S.;
Bandinelli, D.; Toniolo, R.M.; Aulisa, Keywords: scoliosis; vertebral rotation; limb inequality; limb discrepancy; sacral shelf obliquity;
A.G. Vertebral Rotation in Functional functional scoliosis; sacral shelf inclination
Scoliosis Caused by Limb-Length
Inequality: Correlation between
Rotation, Limb Length Inequality,
and Obliquity of the Sacral Shelf. J.
1. Introduction
Clin. Med. 2023, 12, 5571. https://
doi.org/10.3390/jcm12175571
The term scoliosis, first used by Galen, derives from the Greek word “crooked”.
In 1741, André used the crooked spine as his symbol for orthopedics [1]. Scoliosis is a
Received: 19 June 2023
structured deformity of the spine that is expressed in three dimensions of space: a curve
Revised: 18 August 2023
in the frontal plane (which is the most evident manifestation) is associated with vertebral
Accepted: 22 August 2023
rotation in the transverse plane (which is the characteristic element) and a deformity in
Published: 26 August 2023
the sagittal plane. The term “structured” means that one cannot spontaneously correct
the curve. Scoliosis can be classified according to its etiology, the location of the curve,
and the extent of angular deviation. The most frequent type of pathology is idiopathic
Copyright: © 2023 by the authors.
scoliosis, with a prevalence of 0.47–5.2%. The prevalence and curve severity are higher
Licensee MDPI, Basel, Switzerland. for girls than for boys, and the female-to-male ratio increases with increasing age among
This article is an open access article children. The ratio is 1.5:1 for the mild forms, while it increases by 10:1 for the more severe
distributed under the terms and forms (>30◦ Cobb). A diagnosis of idiopathic scoliosis is made if a non-idiopathic form has
conditions of the Creative Commons been excluded [2]. Clinically, a patient with scoliosis will present with an asymmetry of the
Attribution (CC BY) license (https:// shoulder line, an asymmetry of the size triangles between the line of the arms and that of
creativecommons.org/licenses/by/ the hips, and a hump in the anterior bending test. Clinical suspicion should be confirmed
4.0/).

J. Clin. Med. 2023, 12, 5571. https://doi.org/10.3390/jcm12175571 https://www.mdpi.com/journal/jcm

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J. Clin. Med. 2023, 12, 5571

based on the presence of a curve of the spine on radiographic examination. The Report of
the Terminology Committee of the Scoliosis Research Society, which is the international
body responsible for regulating and standardizing the terminology and classifications of
vertebral deformities, states that “scoliosis is a lateral curvature of the spine”. According to
this definition, deviations of the spine in the frontal plane are generically defined as scoliosis.
In the literature, it is universally accepted that for a curve to be defined as scoliosis it must
be greater than 10◦ Cobb in the frontal plane, but there is no agreement on the pathogenesis
of idiopathic scoliosis. Various theories have been posited to explain the pathogenesis of
idiopathic scoliosis; these can be classified into the following groups to provide a better
understanding of the multifactorial pathogenesis of AIS: genetics, mesenchymal stem
cells, tissues, spine biomechanics, neurology, hormones, biochemistry, environment, and
lifestyle [3–6]. Despite much research, the mechanism underlying the onset of idiopathic
scoliosis remains unknown. Furthermore, the official terminology distinguishes another
type of scoliosis in addition to the structured one mentioned above, namely, unstructured
scoliosis, also called scoliotic attitude or “functional scoliosis”. This is a mild, non-structural,
and steady lumbar curve often secondary to limb length inequality without vertebral
rotation. The major skeletal reactions or adaptations to leg length discrepancy are pelvic
obliquity and scoliosis [7–9]. Leg length inequality (LLI) or discrepancy is a difference
between the length of the legs and is a common orthopedic condition with a prevalence rate
of 90% in the general population, and it is more frequently observed among the pediatric
population [10]. Leg length discrepancy can be measured clinically by measuring the length
from the anterior superior iliac spine to the medial malleolus and calculating the difference
between the two lower limbs. Another method of measurement is to calculate the difference
in length between the two malleoli in the supine position. A more precise method is to
measure the difference in length on a radiograph of the lower extremities under load. It is
possible to measure the length by calculating the difference in the height of the iliac crest or
the femoral heads on a radiograph of the pelvis or by measuring the lengths of the tibia
and femur. The femur is measured from the top of the greater trochanter to the most distal
point of the lateral condyle. The tibia is measured from the most proximal point to the most
distal point at the ankle joint line.
Length differences are typically less than 10 mm, asymptomatic, and develop as
a momentary condition during growth. In some rare cases, children are born with leg
discrepancies, while other causes are acquired (fractures, tumors, radiation, infections). LLI
is classified as mild (0–2.5 cm), moderate (2.5–6 cm), and severe (>6 cm) [11] and can be
categorized etiologically as structural or functional. Structural or anatomical LLI is due to
the physical shortening or lengthening of a unilateral lower extremity, while functional LLD
refers to the apparent asymmetry of the lower extremity, without the physical shortening
or lengthening of the osseous components of the lower limb. A functional leg length
discrepancy (LLD) refers to a situation where one leg appears longer than the other due to
factors such as pelvic tilt, muscular imbalances, or poor alignment, rather than an actual
difference in bone length. Unlike a structural LLD, where there is a measurable difference
in the bones’ length, a functional LLD is often temporary and can be corrected with proper
intervention. If the pelvis is tilted or rotated, it can affect the apparent leg lengths. This can
occur due to muscle imbalances, joint issues, or posture problems. Tightness or weakness in
the hip, thigh, or calf muscles can lead to altered alignment and functional LLD. Tightness
in soft tissues, such as ligaments and fascia, can contribute to uneven alignment of the
pelvis and legs. Unlike structural LLD, functional LLD cannot be corrected with a lift, but
it requires physical therapy to assess posture, muscle imbalances, and alignment so as to
develop a personalized exercise program that addresses the underlying causes of functional
LLD [7]. The effects of LLD on the spine vary depending on the cause and size of the
difference. The correlation between LLI, the alignment of the spine, and pelvic imbalance
has been assessed in various ways, even methods based on simulating LLI [12] and studying
its consequences for trunk, spinal, and pelvic posture [13–15]. These parameters regress

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with the equalization of LLI [16]. Scoliosis due to LLD is referred to as functional scoliosis,
and it totally or partially regresses when the LLD is eradicated.
The pattern of scoliosis associated with LLD is described as compensatory, non-
structural, and non-progressive, but it has been suggested that LLD can produce structural
changes in the spine over time.
LLD can also occur secondary to scoliosis, particularly in the case of compensatory
scoliosis. In these cases, LLD appears as the result of an asymmetrical load on the lower
extremities. However, the factors associated with variations in LLD and its relationship
with pelvic obliquity are unknown [9]. Moreover, the literature provides discordant results
on the degree of LLI that can cause vertebral misalignment. Some authors believe that an
LLD of 5 mm or less has real significance for mechanically related dysfunctions around the
hips, pelvis, and spine, while other investigators believe that an LLD of less than 1 cm is
not significant and has no pathological implication [11–17].
No study has ever investigated the specific relationship between LLI, sacral inclination,
and vertebral rotation in patients of growing age with functional scoliosis (Cobb < 10◦ ). As
previously mentioned, the most frequent type of scoliosis is “adolescent idiopathic scoliosis
(AIS)”. Its cause is unknown, and the prognostic factors linked to curve progression are
still debated. Prognosis can vary widely depending on factors such as the severity of the
curvature, the age of onset, the underlying cause, and the patient’s overall health.
The severity of the curvature (degree of spinal curvature measured based on the Cobb
angle on radiograph) is a crucial factor in predicting the prognosis. Mild curves (less than
20–25 degrees) are generally considered as less likely to progress significantly, while more
severe curves may have a higher likelihood of progression.
Age of onset can influence prognosis. Early onset scoliosis, occurring before puberty,
tends to have higher potential for progression due to growth spurts during adolescence.
Skeletal maturity is another important prognostic factor; once growth is complete, the
progression of scoliosis usually slows down significantly. The greater the stage of skeletal
maturity is, the less likely the curvature will progress.
Curve pattern and location: The location and pattern of the curves can impact progno-
sis, as can gender; in general, girls are more likely to experience scoliosis progression than
boys, especially during growth spurts. This is particularly true for idiopathic scoliosis.
Family history: A family history of scoliosis might increase the likelihood of progres-
sion, suggesting a genetic predisposition. It is not known which has the greatest influence
on prognosis.
Recently, many studies have demonstrated the importance of vertebral rotation. In-
deed, the maintenance of the viscous–elastic property of the intervertebral disc depends on
this aspect, which is directly linked, together with the Cobb degree, to the distribution of
forces on the spine. In children, especially, the spine is in a state of dynamic equilibrium;
the entire spine is subject to elastic deformation during movement and has the ability to
return to its primitive configuration. It has been demonstrated that when the column starts
in an altered condition, it imposes alterations of movement followed by a change in elastic
return, which can lead to structural changes over time [18]. These alterations have a great
impact on the evolution of the scoliotic curve. The resetting of vertebral rotation has been
shown to change the progression of the curve once conservative treatment has ended [19].
Based on these premises, we decided to focus our attention on vertebral rotation in curves
of less than 15 degrees in patients of growing age with LLI.
The aim of this study was to research the presence of vertebral rotation in functional
scoliosis caused by limb length inequality (LLI). In addition, we aimed to examine the
correlation between LLI, sacral inclination, and vertebral rotation to discover whether there
is a quantitative measure of LLI in which the risk of vertebral body rotation increases.

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2. Materials and Methods

2.1. Design of the Study
This study was a retrospective analysis of 343 consecutive patients (male and female)
who underwent view-standing X-rays of the whole spine in our hospital from September
2022 to November 2022. We only selected X-rays from our hospital database, featured in
our Carestream program (Figure 1).

Figure 1. Flow chart of the study design.

2.2. Population
The inclusion criteria were a Cobb angle < 15◦ , primary scoliosis, the absence of
thoracic curve, sacral shelf, femoral heads visible on X-ray, and age less than 16 years
old. The exclusion criteria were curves secondary to other pathologies, thoracic curves,
or combined curves, curves with a Cobb angle > 15◦ , sacral shelf, and femoral heads that
were not visible. From among 343 patients, we found 89 patients meeting the inclusion
criteria. In the X-ray of the spine in two projections, we measured the presence of a vertebral
rotation seat of the curve, as well as the entity of the curve using the Cobb degree, observed
the Risser degree, and determined whether the scoliosis was primary or secondary to
bone causes (Figure 2A,B). We also measured limb length inequality (LLI) and sacral shelf
inclination. The femoral horizontal reference line was defined as a horizontal line tangent
to the top of the highest part of the femoral head. The height between the right and left
femoral horizontal reference lines was defined as the size of the LLI. The inclination of
the sacral shelf was measured by drawing a horizontal line at the level of the first two
foramina or the sacroiliac joint, while vertebral rotation was evaluated using a Perdriolle’s
torsionmeter (Figure 3). To render the measurements more precise, in addition to the X-ray
grid reference, we double-checked the measurement using a ruler placed on the computer
screen. During the visit of the patient with suspected scoliosis, we evaluated the symmetry
of the sacral shelf and measured the length of the lower limbs. It is important to observe the
change in the alignment of the spine by applying a lift below the limb, showing a measure
inferior to the contralateral limb (Figure 4).
All measurements were performed by a single operator.

2.3. Statistical Analysis

The statistical analysis was performed using STATA (Stata, College Station, TX, USA),
and a p value less than 0.05 was considered statistically significant.
The Shapiro–Francia test was used to check the normality of each variable. Pearson’s
correlation coefficient and the logistic regression type (r2) were calculated for the correlation
between pelvic inclination, vertebral rotation, and limb length inequality (LLI).

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A B

Figure 2. (A) Clinical aspects of scoliosis; (B) Radiological aspects of scoliosis.

Figure 3. These figures show how the measurements were taken. A: Pedriolle’s Torsionometer.

The correlation of pelvic obliquity (SSI) and LLI was calculated for the whole group
(N = 89 subjects) and divided by vertebral rotation (Perdriolle 0◦ group N = 38; Perdriolle
5–15◦ group N = 51).

Figure 4. Clinical aspects of functional scoliosis.

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J. Clin. Med. 2023, 12, 5571

3. Results
Fifty-seven out of eighty-nine patients had vertebral rotation (51% of cases) of the
apical vertebrae. Most cases involved L2 (21 out of 57 cases). The Risser sign was
1.8 ± 1.9 (mean ± SD). A total of 33 patients had a left lumbar curve, 36 had a left dorso-
lumbar curve, 3 had a right lumbar curve, and 17 had a right dorso-lumbar curve (Table 1).

Table 1. Curve location and n◦ of patients.

Curve Location n◦ Patients

Left lumbar 33
Left dorso-lumbar 36
Right lumbar 3
Left dorso-lumbar 17

In these patients, vertebral rotation ranged from 5 to 15 Peridiolle’s degrees. In total,

25 showed 5 degrees of rotation, 27 showed 10 degrees of rotation, and 5 showed 15 degrees
of rotation (Table 2). Seven patients did not show lower limb inequality, and of these, only
one showed vertebral rotation.

Table 2. Perdriolle’s value and n◦ of patients.

Perdriolle N◦ Patients
5 25
10 27
15 5

Fifty-eight patients had between 5 mm and 24 mm of LLI, while the remaining patients
had a lower degree of LLI. Of these 58 patients, only 15 did not show vertebral rotation,
while among the 24 patients with LLI of less than 5 mm, 14 not show vertebral rotation
(Table 3).

Table 3. LLI, n◦ of patients and rotation.

LLI 5–24 LLI < 5 mm

LLI 5–24 LLI < 5 mm
with Rotation with Rotation
N◦ Patients 58 24 43 10

The mean LLI value of the whole group was 6.5 ± 4.59 mm. Splitting the patients into
two subgroups, those without rotation and those with rotation, the mean LLI value was
5.2 ± 4.87 mm for the first group and 7.4 ± 4.18 mm for the second group.
The mean value of sacral shelf inclination (SSI) for the whole group was 2.8 ± 2.53 mm,
with a value of 1.4 ± 2.00 mm for patients without rotation and 3.9 ± 2.39 mm for patients
with Perdriolle ranging from 5 to 15◦ . The correlation between sacral inclination and LLI
showed a p > 0.001 in both subgroups, with rotation and without rotation (Table 4).

Table 4. Mean values of lower limb inequality (LLI) and sacral shelf inclination (SSI) in the whole
group and in patients with and without rotation.

LLI SSI
(Lower Limb Inequality) (Sacral Shelf Inclination) Cohen d p Value
Mean ± SD Mean ± SD
Total sample 6.5 ± 4.59 2.8 ± 2.53 0.97 p < 0.001
With Rotation 7.4 ± 4.18 3.9 ± 2.39 1.03 p < 0.01
Without rotation 5.2 ± 4.87 1.4 ± 2.00 0.94 p < 0.001

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The correlation between the inclination of the sacral shelf and vertebral rotation,
variables in a statistical relationship of the logistic regression type, showed an R2 value of
0.22 and a p < 0.001; both were statistically significant (Figure 5A).
Furthermore, we found a predictive probability according to which, for each millime-
ter of inclination of the sacrum, it is possible to predict a rotation of the vertebral body of
0.58 degrees, and we found that with a threshold value of 2 mm of inclination, the probabil-
ity of developing a rotation exponentially increases.
Moreover, the predictive probability of vertebral rotation is 0.23 in the absence of
obliquity of the sacral shelf, while it is 0.99 for 11 mm of sacral inclination (Figure 5B).
Instead, the relationship between LLI and vertebral rotation, also variables in a sta-
tistical relationship of the logistic regression type, showed an R2 of 0.08, a statistically
significant value but one that is smaller than that of the relationship between the sacral
shelf and vertebral rotation, for which the p value was 0.0016. This value is statistically
significant but lower than that of the previous correlation (Figure 6A).
We found that 5 mm is the value of LLI that increases the risk of vertebral rotation.
Moreover, the probability of being in the patient group without spinal rotation was 0.38 for
patients without heterometry, whereas it increased to 0.93 in the case of heterometry equal
to 26 mm (Figure 6B).
The correlation between sacral inclination and LLI was a linear-regression-type statis-
tical relationship and showed a value of p < 0.001 (Figure 7).
We found that every mm of length leg inequality corresponds to 0.3 mm of sacral shelf
inclination; therefore, vertebral rotation is very likely to occur when LLI reaches a threshold
of 5 mm.

Figure 5. (A) Relationship between sacral shelf inclination and vertebral rotation. (B) Predictive
probability of vertebral rotation correlated with sacral shelf inclination.

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Figure 6. (A) Relationship between LLI and vertebral rotation. (B) Probability of being in the patient
group without or with vertebral rotation based on LLI.

Figure 7. Relationship between LLI and sacral shelf inclination.

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4. Discussion
According to the literature, to define a curve as “scoliosis”, the deformity in the coronal
plane must be greater than 10◦ Cobb, and it must present vertebral rotation in the transverse
plane [20–23]. Instead, there is a consensus that “functional scoliosis” is an asymmetry in
the coronal plane without evidence of a thoracic hump or lumbar asymmetry based on
Adam’s test. Often, this alteration is due to limb length discrepancy; it is not progressive
and can be corrected without weight bearing [4–24]. The results of the present study
demonstrated the presence of vertebral rotation in patients with functional scoliosis caused
by LLI, and it was correlated with 5 mm of LLI, which will create changes in vertebral and
sacral alignment. Previous studies investigated the relationship between LLI and spinal
posture with conflicting findings. To the best of our knowledge, this is the first study
focusing on vertebral rotation in pediatric patients with functional scoliosis determined
by LLI. Moreover, we demonstrated a correlation between LLI, SSI, and vertebral rotation.
These results are important, enabling us to better understand the role of vertebral rotation,
a parameter related to the progression of this disease [12–25].
Hoikka et al. [12], in a study of 100 patients with an average leg length inequality of
5 mm and a main age of 47 years, found a correlation between LLI and sacral inclination
but no relationship between LLI and the Cobb degree. Specht et al., in a retrospective study
of 106 consecutive routine diagnostic X-ray procedures, found that 60% of the patients
had LLI > 3 mm, 40% had LLI > 6 mm, 50% of the latter had lumbar scoliosis, and only
30% of the first group had lumbar scoliosis [26]. Gibson et al. [27], in a study of patients
with LLI ranging from 15 to 55 mm due to a femoral shaft fracture sustained after skeletal
maturity, observed that functional scoliosis resolved nearly completely after correction of
the leg length discrepancy. However, in this study, the patients showed a contradictory
increase in lateral flexion of the column to the shortest leg, although the spine returned to
symmetry after LLD correction. This finding contradicts the study of Papaioannou et al.,
which only included patients who had LLI since childhood (the patients were young adults,
and their LLI ranged from 1.2 to 5.2 cm) [28]. These results suggest that a long period of
functional scoliosis may result in permanent biomechanical changes in the lumbar spine.
The period for which the spine is subjected to functional scoliosis also seems to affect the
risk of degenerative changes. Manganiello et al. conducted two different studies to analyze
the impact of LLI on the lumbar column, and they even suggested that low LLI can induce
high desalination of the lumbar region with respect to major LLI (>2 cm) [29,30]. They also
proposed that LLI could be the primum movens for the onset of structured scoliosis. These
findings supplemented those of the aforementioned studies demonstrating that changes
in spinal alignment can form over time, suggesting a possible structuring of vertebral
rotation over time secondary to the difference in length of the lower limbs. Although the
recent literature has shown a relationship between the LLI and lumbar scoliosis, Grivas
et al. analyzed patients with LLI ranging from 0.5 cm to 2 cm and found that LLI was
significantly correlated with the 4DF (4D Formetric DIERS apparatus) reading of pelvis
rotation, pelvic tilt, and surface rotation, while it was not correlated with the scoliosis
angle or the scoliometer reading at the lumbar level [31]. Instead, Betsch et al. simulated
LLI > 2 cm in 100 volunteers (53 females and 47 males) with a mean age of 34 years, finding
a correlation between LLI, pelvic inclination, surface rotation, and lateral inclination (all
parameters were investigated with raster stereography). In a previous study, the authors
did not observe postural impairment for LLI < 2 cm [13,14].
Furthermore, a relationship between leg length inequality and adolescent idiopathic
scoliosis (AIS) was also demonstrated. In a recent study published in the Asian Spine
Journal, Kobayashi et al. [9] demonstrated a direct relationship between LLI, the Cobb an-
gle, and vertebral rotation in 23 patients with AIS. A correlation was found between
LLI and vertebral rotation, but compared to our study, the number of patients was
small and included scoliosis patients with a Cobb angle between 10 and 30 degrees and
LLI > 2 cm. Sekiya et al. [32] found a correlation between functional LLI, pelvic obliquity,
and the Cobb angle of the lumbar region, but they suggested that in this case, LLI was

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secondary to AIS. This study revealed that patients with AIS have functional LLD but
not significant structural LLD. The authors reported that the relationship between the
lumbar Cobb angle and functional LLD indicates that the lumbar curve contributes to
functional LLD; thus, the difference between functional and structural LLDs represents a
compensatory mechanism involving the extension and flexion of the lower limbs. None of
these studies specifically focused on the consequences of LLI for both the alignment of the
sacral shelf and the lumbar spine, exploring how these affects vertebral rotation. Moreover,
patients affected by idiopathic AIS show a rotation of the pelvis and the sacrum in addition
to an inclination, and it has been demonstrated that these pathologies can arise because of
an LLI. In the radiographs of patients affected by scoliosis, the right ilium often appears to
be wider than the left ilium in patients with major thoracic curves, while the left ilium often
appears to be wider than the right ilium in patients with major thoracolumbar/lumbar
curves. Gum et al. also noted this phenomenon and interpreted it as the result of transverse
pelvic rotation. They suggested that the transverse plane pelvic position that accompanies
major thoracic curves is the fourth transverse plane compensation. The direction of trans-
verse pelvic rotation is the same as that for the main thoracic curve in most patients with a
compensatory thoracolumbar/lumbar curve [15–34]. These studies can, therefore, explain
the relationship that we found in our study between leg length inequality, sacral shelf, and
vertebral rotation.
Our study was limited by the difficulty of undertaking a differential diagnosis between
structured scoliosis and functional scoliosis due to LLI when there is vertebral rotation,
because most lumbar curves are not progressive and the prognostic factors and causes of
AIS are not yet known.
Our future objectives will be to follow these patients up to skeletal maturity, to observe
the evolution of functional scoliosis due to LLI, and to understand the role of vertebral
rotation. Another interesting point to evaluate is whether the use of a custom foot orthosis
with sole lift would be useful in cases of a discrepancy starting from 5 mm to avoid the
onset of a possible rotation that could not be reduced over time.

5. Conclusions
Functional scoliosis due to leg length inequality can involve vertebral rotation with
a direct correlation between leg length inequality, sacral shelf inclination, and vertebral
rotation. A limb length inequality greater than 5 mm can be considered as the threshold
value above which the sacral shelf could tilt, causing a rotation of the spine.

Author Contributions: A.G.A. and M.M. participated in the conception, design and coordination,
acquisition of data, analysis, and interpretation of data, drafted the manuscript, and performed the
statistical analysis. S.C., D.B. and R.M.T. helped to draft the manuscript. All authors have read and
agreed to the published version of the manuscript.
Funding: This work was supported by the Italian Ministry of Health with “Current Research funds”.
No benefits in any form have been or will be received from a commercial party related directly or
indirectly to the subject of this manuscript. The manuscript submitted does not contain information
about medical device(s)/drug(s).
Institutional Review Board Statement: Considering the retrospective nature of the analysis, the cur-
rent study did not require the approval of the local ethics committee according to current legislation,
but a notification was sent. The study was conducted by the Declaration of Helsinki and approved
by the ethics committee of Bambino Gesù Children Hospital, Rome. Etihic code RAP-2023-0008
Approved 12 June 2023.
Informed Consent Statement: Written informed consent to participate in this study was provided
by the participants. The participants provided written consent for the publication of data.
Data Availability Statement: Datasets generated and/or analyzed during the current study are
available from the corresponding author upon reasonable request.
Conflicts of Interest: The authors declare no conflict of interest.

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Clinical Medicine

Article
Is Thoracic Kyphosis Relevant to Pain, Autonomic Nervous
System Function, Disability, and Cervical Sensorimotor Control
in Patients with Chronic Nonspecific Neck Pain?
Ibrahim M. Moustafa 1,2,3 , Tamer Shousha 1,2,3 , Ashokan Arumugam 1,2,4 and Deed E. Harrison 5, *

1 Department of Physiotherapy, College of Health Sciences, University of Sharjah, Sharjah 27272, United Arab Emirates
2 Neuromusculoskeletal Rehabilitation Research Group, RIMHS–Research Institute of Medical and Health Sciences,
University of Sharjah, Sharjah 27272, United Arab Emirates
3 Faculty of Physical Therapy, Cairo University, Giza 12613, Egypt
4 Sustainable Engineering Asset Management Research Group, RISE-Research Institute of Sciences and Engineering,
University of Sharjah, Sharjah 27272, United Arab Emirates
5 CBP Nonprofit (A Spine Research Foundation), Eagle, ID 83616, USA
* Correspondence: [email protected]

Abstract: There is great interest in thoracic kyphosis, as it is thought to be a contributor to neck

pain, neck disability, and sensorimotor control measures; however, this has not been completely
investigated in treatment or case control studies. This case control design investigated participants
with non-specific chronic neck pain. Eighty participants with a defined hyper-kyphosis (>55◦ )
were compared to eighty matched participants with normal thoracic kyphosis (<55◦ ). Participants
were matched for age and neck pain duration. Hyper-kyphosis was further categorized into two
distinct types: postural kyphosis (PK) and Scheuermann’s kyphosis (SK). Posture measures included
formetric thoracic kyphosis and the craniovertebral angle (CVA) to assess forward head posture.
Sensorimotor control was assessed by the following measures: smooth pursuit neck torsion test
(SPNT), overall stability index (OSI), and left and right rotation repositioning accuracy. A measure of
autonomic nervous system function included the amplitude and latency of skin sympathetic response
(SSR). Differences in variable measures were examined using the Student’s t-test to compare the
means of continuous variables between the two groups. One-way ANOVA was used to compare
Citation: Moustafa, I.M.; Shousha, T.;
mean values in the three groups: postural kyphosis, Scheuermann’s kyphosis, and normal kyphosis
Arumugam, A.; Harrison, D.E. Is group. Pearson correlation was used to evaluate the relationship between participant’s thoracic
Thoracic Kyphosis Relevant to Pain, kyphosis magnitude (in each group separately and as an entire population) and their CVA, SPNT,
Autonomic Nervous System Function, OSI, head repositioning accuracy, and SSR latency and amplitude. Hyper-kyphosis participants had
Disability, and Cervical Sensorimotor a significantly greater neck disability index compared to the normal kyphosis group (p < 0.001) with
Control in Patients with Chronic the SK group having greatest disability (p < 0.001). Statistically significant differences between the
Nonspecific Neck Pain? J. Clin. Med. two kyphosis groups and the normal kyphosis group for all the sensorimotor measured variables
2023, 12, 3707. https://doi.org/
were identified with the SK group having the most decreased efficiency of the measures in the hyper-
10.3390/jcm12113707
kyphosis group, including: SPNT, OSI, and left and right rotation repositioning accuracy. In addition,
Received: 16 April 2023 there was a significant difference in neurophysiological findings for SSR amplitude (entire sample
Revised: 21 May 2023 of kyphosis vs. normal kyphosis, p < 0.001), but there was no significant difference for SSR latency
Accepted: 25 May 2023 (p = 0.07). The CVA was significantly greater in the hyper-kyphosis group (p < 0.001). The magnitude
Published: 27 May 2023 of the thoracic kyphosis correlated with worsening CVA (with the SK group having the smallest CVA;
p < 0.001) and the magnitude of the decreased efficiency of the sensorimotor control measures and the
amplitude and latency of the SSR. The PK group, overall, showed the greatest correlations between
thoracic kyphosis and measured variables. Participants with hyper-thoracic kyphosis exhibited
Copyright: © 2023 by the authors.
Licensee MDPI, Basel, Switzerland.
abnormal sensorimotor control and autonomic nervous system dysfunction compared to those with
This article is an open access article normal thoracic kyphosis.
distributed under the terms and
conditions of the Creative Commons Keywords: thoracic spine; neck pain; kyphosis; sensorimotor control; posture
Attribution (CC BY) license (https://
creativecommons.org/licenses/by/
4.0/).

J. Clin. Med. 2023, 12, 3707. https://doi.org/10.3390/jcm12113707 https://www.mdpi.com/journal/jcm

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J. Clin. Med. 2023, 12, 3707

1. Introduction
Neck pain is the fourth leading cause of long-term disability with an annual prevalence
exceeding 30%, most often in females [1]. Neck pain is a common condition with several
proposed biomechanical and psycho-social contributing factors [2]. While the mechanical
causes of neck pain are not completely understood, they are thought to be linked to
the interconnected functions of anatomical components of the cervical spine [2]. Neck
discomfort can be caused by any incident that alters joint mechanics or muscle function via
alterations and increases in general loading and load sharing of the various tissues [2–4].
For instance, several studies have demonstrated the impact of thoracic spine abnormalities
on the kinematics of the cervical spine and overall neck mobility [5–7]. In particular, studies
have demonstrated a link to movement coordination between the cervical and thoracic
spines [3,5,6,8]. While the prevalence of neck disorders is greater in older persons, who also
have a higher prevalence of thoracic hyper-kyphosis [6], neck pain is also one of the most
common musculoskeletal disorders in young adult populations, with a reported 12-month
prevalence ranging from 42 to 67% [9–11]. An explanation for such a high rate of neck pain
in young and older populations is possible concomitant impairments in the thoracic spine
leading to a dysfunction of the cervico-thoracic musculature such as the serratus anterior,
levator scapulae, and trapezius [12,13].
Since changes in sagittal thoracic alignment have been reported to alter the mechanical
loading of the cervical spine [14,15], this may subtly or overtly impair proprioceptive
afferentation from spine ligaments, muscles, and discs, which are considered to be major
components of sensorimotor control supplying the essential neurophysiological informa-
tion for feedforward and feedback responses via linkages to the vestibular, visual, and
central nervous systems [16–18]. Sensorimotor control is altered in neck pain populations
compared to healthy controls, where slower reaction times in visual acuity, cervical move-
ment, and inefficient motor control in general has been reported [19,20]. It is unclear if
the altered sensorimotor control is causative of neck pain and disability or a result due to
kinesiophobia (fear-based movement variables) [21]; however, it is clear that inefficient sen-
sorimotor control is part of the cycle of chronicity and likely influences recovery [16–21]. In
addition to sensorimotor control influences, several studies show that the cervical receptors
and the sympathetic nervous system have direct interactions [22–24]. However, there is
limited evidence suggesting that the autonomic nervous system is sensitive to alterations in
articular afferent input driven by thoracic hyper-kyphosis and joint dysfunction [22,23,25].
It is known that thoracic hyper-kyphosis is related to a patients’ pain, disability, shoul-
der kinematics, and general health status [26–31]. The threshold for hyper-kyphosis has
been reported to be 45◦ on x-rays (T4-T12 and T5-T12) for pain and disability [26,27], while
the 60◦ value has been reported to be the threshold for more severe disability as in adult
spine deformity cases [28,29]. The assumption that a normal thoracic alignment and normal
cervical kinematics are important for a better afferentation process has some preliminary
evidence [5–8,12–14]. However, studies have not fully investigated the relationship be-
tween hyper-kyphosis, forward head posture, and the correlation (if any) on sensorimotor
control measurements and the autonomic nervous system.
In general, there is a lack of studies assessing the effect of the thoracic spine sagittal
alignment on cervical pain, autonomic nervous system function, disability, and sensori-
motor control. Therefore, the purpose of this study was to investigate the correlation in
sensorimotor control, neck disability index, and autonomic dysfunction in chronic nonspe-
cific neck patients with a thoracic hyper-kyphosis compared to a matched group of normal
kyphosis participants but also having chronic nonspecific neck pain. We hypothesized
that patients with chronic neck pain and a thoracic hyper-kyphosis would have impaired
sensorimotor control and autonomic dysfunction compared to those chronic neck pain
patients with a normal thoracic alignment. Secondarily, we hypothesized that the magni-
tude of thoracic kyphosis would be correlated to the measures of sensorimotor control and
autonomic nervous system function as performed herein.

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2. Materials and Methods

In this cross-sectional study, we compared 80 young adults over the age of 18 years
with chronic nonspecific neck pain and thoracic hyper-kyphosis to 80 matched individuals
with chronic nonspecific neck pain who had a normal thoracic kyphotic alignment. Par-
ticipants were considered matched if their age difference was within 2 years and if their
duration of neck pain was of a similar length of time. When the pain duration varied by less
than two months, participants were deemed to be matched. Participants were patients re-
cruited from a specialized pain and rehabilitation unit at the Farouk Hospital, Cairo, Egypt
from January to August 2022. All cases received a thorough examination in the pain clinic,
and all hyper-kyphotic cases underwent radiological assessment. Ethical approval was
obtained from the Research and Ethics Committee at Cairo University (CA-REC-22-5-20),
with informed consent obtained from all participants prior to data collection in accordance
with relevant guidelines and regulations. A flow chart of the recruitment process is shown
in Figure 1.

Figure 1. Participant study flow chart for group inclusion and exclusion.

2.1. Participant Inclusion and Exclusion Criteria

2.1.1. Inclusion
All participants had to have the diagnosis of chronic non-specific neck pain (CNSNP)
with reduced cervical spine range of motion. Thoracic hyper-kyphotic participants were
screened with a thorough examination by an orthopedic surgeon, including spine radiogra-
phy, to rule out serious spine pathologies. However, participants with mild to moderate
Scheuermann’s kyphosis (SK) (SK participants were diagnosed via radiography and clinical
examination with the orthopedic surgeon) were permitted in the hyper-kyphotic sample,
though SK participants were also analyzed as a subgroup of hyper-kyphosis to identify any
possible differences. See the results section for details. Participants with normal kyphosis

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did not receive thoracic spine radiographic imaging, as there was no clinical rationale
for imaging in these participants; thus, an external measurement of thoracic kyphosis
was chosen to make comparisons in all participants. Prior to inclusion, participants were
evaluated by measuring the sagittal thoracic kyphotic angle ICT-ITL (max) using the 4D
formetric system (note it is a 4D system, as it allows for a time variable to capture any
sagittal shift and sway over 60 s) where ICT-ITL (max) is measured between tangents from
the cervicothoracic junction (ICT-T1) and that of the thoracolumbar junction (ITL-T12). The
reproducibility of results is excellent, making this non-invasive system appropriate for
clinical assessment, as the reliability of thoracic kyphosis measurement is excellent with
coefficients of variation of approximately 7% (3.5 degrees) for angulations [32,33]. Figure 2
depicts this measurement. Hyper-kyphosis participants were included if the ICT-ITL (max)
angle measured more than 55◦ . Normal kyphosis participants were defined as the ICT-ITL
(max) angle being less than 55◦ [33]. There is good correlation between the formetric vs.
Cobb angle of thoracic kyphosis, but formetric measurements consistently overestimates
kyphosis by an average of 5–7◦ , indicating that the radiographic kyphosis would be approx-
imately 48–50◦ , which is the upper end of normal and the cutoff value for where thoracic
kyphosis begins to be associated with pain and disability [26,27,30,31,33–35].

Figure 2. 4D formetric device measurement of thoracic kyphosis and trunk inclination where kyphotic
angle ICT-ITL (max) is measured between tangents of cervicothoracic junction (ICT) and of thoracolum-
bar junction (ITL). ICT: inflectional points from cervical to thoracic spine. ITL: inflectional points
from thoracic to lumbar spine. KA: kyphosis angle. LA: lordosis angle. VP: vertebra prominence.
DM: dimple.

2.1.2. Exclusion
Exclusion criteria included the presence of any signs or symptoms of medical “red
flags”, a history of previous spine surgery, vertebral fracture, signs or symptoms of upper
motor neuron disease, vertebrobasilar insufficiency, amyotrophic lateral sclerosis, and
bilateral upper extremity radicular symptoms. Detailed exclusions were:

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J. Clin. Med. 2023, 12, 3707

• Neck pain associated with whiplash injury;

• Neck pain with bilateral cervical radiculopathy;
• Fibromyalgia syndrome;
• Surgery in the neck area, regardless of the cause;
• Neck pain accompanied by vertigo caused by vertebra-basilar insufficiency or accom-
panied with non-cervicogenic headaches;
• Recent or recurrent middle ear infections or any hearing impairment requiring the use
of a hearing aid;
• Visual impairment not corrected by glasses;
• Any disorder of the central nervous system.

2.2. Measurement Procedures

2.2.1. ICT-ITL (Max)
The thoracic posture was measured in a neutral position to ensure consistency between
repeated images captured in the same session; also, this would aid comparison with other
studies that measured Cobb’s angle for thoracic kyphosis in radiographic studies. Each
participant was positioned 2 m from the measurement system in front of a black background
screen, and a valid and reliable formetric system [32,33,35] was used to analyze 3D body
posture displacements (DIERS Medical Systems, Chicago, IL, USA). The column height
was aligned to move the relevant parts of the patient’s back into the center of the control
monitor by using the column up/down button of the control unit. A permanent mark fixed
with a tape on the floor was used to ensure the best lateral and longitudinal position of
the patient. The participant’s back (including the upper gluteal region) was uncovered to
allow better imaging of the back. The participants’ hair was tied up (when needed) to allow
visualization of the vertebral prominences. The system was ready for image recording
when the participant was correctly positioned in the participant’s perception of their neutral
resting, relaxed posture position, being defined as the relaxed upright stance, with feet hip
width apart and barefooted, where the participant was instructed to:
• look straight ahead in a relaxed breathing state with their head in a neutral position,
not being twisted or bent;
• relax their shoulders, do not hunch them or rotate them forward;
• keep their upper arms, elbows and hands comfortably at their sides;
• stand with their legs straight, but with knees relaxed, not locked back (preventing
hyperextension).
Thoracic kyphosis was measured as the maximum kyphosis between tangents from
the cervicothoracic junction (ICT-T1) and that of the thoracolumbar junction (ITL-T12).
This would be considered a total thoracic kyphosis from T1–T12 vertebral levels. Kyphotic
participants were included if the angle measured 55◦ or more and normal kyphosis if
the angle measured less than 55◦ [26,27,30,33–35]. There is a good correlation between
the formetric measurement and Cobb angle of thoracic kyphosis, but the former one
consistently overestimates kyphosis by an average of 5–7◦ [33,35].

2.2.2. Craniovertebral Angle (CVA)

To assess the influence of thoracic kyphosis on forward head posture (FHP), we
measured the craniovertebral angle (CVA) in both groups. The CVA is constructed using
C7 spinous process and drawing a line from it to the tragus of the ear. Next, a horizontal
line is drawn through C7 spinous, where the CVA is the acute angle between the two lines.
Typically, when the CVA is less than 50◦ , then a participant is classified as having significant
forward head posture [36,37]. The CVA has excellent reliability to assess forward head
posture [36,37]. Figure 3 presents the CVA.

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J. Clin. Med. 2023, 12, 3707

Figure 3. Measurement of the craniovertebral angle (CVA). Two markers are utilized and placed at
the level of the C7 spinous process and the tragus of the ear; then a line is constructed connecting
these two points. Finally, a horizontal line is drawn using the C7 marker as the reference, and the
CVA is measured as angle A between the two lines [36,37].

2.2.3. Numerical Rating Score (NRS)

Neck pain average intensity over the previous week was assessed using a 0–10 NRS
score ranging from 0 = no pain to 10 = bed ridden and incapacitated. The reliability and
validity of the NRS has been found to be good to high [38].

2.2.4. Neck Disability Index

The neck disability index (NDI) to assess activities of daily living impact was adminis-
tered. The NDI has good reliability, validity, and responsiveness to change [39].

2.2.5. Sensorimotor Control Measures

There is a detailed interplay between proprioception and postural control, such that
normal posture alignment is likely a major component driving the afferentation process
leading to improved sensorimotor integration and motor control. To assess the effects of
thoracic kyphosis and forward head posture on the sensorimotor system, we measured
three common measures of sensorimotor control herein, including the assessment of the
following: (a) cervical joint position sense testing, (b) head and eye movement control, and
(c) evaluation of postural stability.
a. Cervical Joint Position Sense Testing
Head repositioning accuracy (HRA) was assessed with the cervical range of motion
(CROM) device as previously described in the literature (CROM deluxe device by Frabica-
tion: https://www.amazon.com/Fabrication-12-1156-Crom-Deluxe/dp/B00BRCGCNO,
accessed on 19 May 2023). We followed the protocol of Loudon et al., as this is reliable
and valid [40]. The CROM was placed on the participants’ head while they were seated
upright on a stool without a backrest, with both feet supported on the floor with knees
flexed to ≈90◦ . The participant was asked to sit upright in a neutral, non-slouched, and
comfortable thoracic posture attempting to keep the thoracic spine perpendicular to the
plane of the stool. The neutral head position (NHP) was considered as the starting and
reference position, where the CROM was adjusted to zero for the primary plane of ro-
tational movement. Patients were instructed to close their eyes, memorize the starting
position, actively rotate their head to 30◦ about the vertical axis, and reposition their head
to the starting position with no restrictions for speed; only repositioning accuracy was
encouraged. HRA was defined as the difference in degrees between the starting and the

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return positions [41]. Three repetitions were performed within 60 s for both the left and
right directions; for a total of six sets. The test is reported as error in degrees (◦ ), where less
than 10% or 3◦ is normal [40,41].
b. Head and eye movement control: smooth pursuit neck torsion test (SPNT)
Assessment of disturbances in eye movement control by the electro-oculography was
adopted from Tjell et al. [42]. The test was performed with the participant’s head and
trunk in a neutral straight ahead position and then two trunk rotation positions (head
neutral, trunk in 45◦ rotation to each side). Patients were asked to blink three times (for
recognition and elimination in data analysis) and then follow the path of a light as closely
as possible with their eyes. The SPNT test value was defined as the difference between the
average gain in the neutral and torsion positions for left vs. right rotation. Findings are
reported as a percentage (%) of error of corrective saccades (eye movements), where 100%
is perfect (0% error), 10–20% error is normal, and greater than 20% error is abnormal. The
videonystagmography system VisualEyes™ 525 by Interacoustics A/S in Denmark was
utilized to conduct the SPNT test.
c. Postural stability
The Biodex Balance System SD (Biodex Medical Systems, Inc., Shirley, NY, USA) was
used to assess postural stability. Dynamic balance was assessed by simulating displace-
ments in both anterior/posterior (AP) and medial/lateral (ML) directions by changing the
device platform level of stability. The platform provides an objective assessment of balance
using three indices: the overall stability index (OSI), an anteroposterior stability index
(APSI), and a mediolateral stability index (MLSI). These indices are calculated according
to the degree of platform oscillation. Smaller values indicate a good stability level of the
participants. The reported inter-examiner reliability coefficients range between 0.77 and
0.99 [43,44]. Balance indices were calculated over three 10 s trials, with 20 s rest between
trials. The average of three trials was recorded. The balance system was set to a dynamic
position of 4 out of 8.

2.2.6. Sympathetic Skin Response (SSR)

On the day of the study, patients were asked to avoid using medicated lotions and
cosmetics (on the hands), not to engage in physical activity, and avoid smoking, eating,
and drinking coffee two hours prior to the recordings. To acclimatize patients to the
experimental environment, all participants spent 20 min in a room with a temperature of
22–24 ◦ C just before the measurements were taken.
The EMG was used to measure the SSR. Room temperature was maintained at 26 ◦ C
in order to maintain a stable skin temperature [45,46]. The active surface electrodes were
attached on the palmar side, and the references were placed on the dorsum of the hand.
The stimulus was given at the wrist contralateral to the recording side. Measurements were
taken from both left and right sides. An intensity of 20–30 mA with an irregular interval
of more than one minute was applied to prevent habituation. When habituation occurred,
stimulation was delayed for about three or four minutes. Skin potentials were recorded
for a 10 s analysis period. The latency and peak-to-peak amplitude SSR were determined.
Mean values of three trials were used for each parameter. Sweep speed was 500 ms/div.
SSR was considered absent if there was no response after 10 stimuli [47]. In the
SSR trace, the latency and amplitude character points markers placement was corrected
manually if the ones automatically generated by the EMG software were inaccurately
placed. Latencies were measured from the stimulation artifact to the initiation of the
response which is defined as the earliest point where the amplitude begins to increase. The
amplitude is measured from the peak of the first deflection to the peak of the next one
(peak-to-peak) [48].

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2.3. Sample Size Determination

A priori sample size calculation based on a pilot study conducted for 10 patients
indicated that 70 participants per each group would be required to detect an effect size of
0.6. Pain was used as the outcome measure for this calculation. To insure robust data, the
sample size was increased by 14% in order to attain 80 participants per group.

2.4. Statistical Analysis

The one-sample Kolmogorov–Smirnov normality test was used to determine whether
the data were normally distributed, and homogeneity of variance assumption was assessed
by the Levene statistic. Descriptive data were presented as mean ± standard deviation.
The Student’s t-test was used to compare the means of continuous variables, and the Chi-
squared test for categorical variables was used to assess any differences between the two
groups, the entire hyperkyphotic and normal groups. When separating the hyper-kyphosis
sample into the two subgroups, the one-way ANOVA was used to compare the mean values
in the three groups: postural kyphosis, Scheuermann’s kyphosis, and normal kyphosis
group. Post hoc Tukey’s analysis was performed to determine differences between groups,
when ANOVA revealed a significant difference.
A p-value < 0.05 was considered statistically significant. Correlations (Pearson’s r) were
used to examine the relationships between the ICT-ITL (KA-max) in both groups and the
measured variables: SSR amplitude and latency, OSI, left and right rotation repositioning
accuracy, NDI, SPNT, and NRS. The minimal clinically important difference (MCID) of the
of the SSR and NDI outcomes were compared to the existing literature [45,46]. Whereas
the MCID of the sensorimotor control variables were not available in the literature to
our knowledge thus, effect sizes for all variables were measured using Cohen’s d, where
d ≈ 0.2 is limited effect, d ≈ 0.5 is a moderate effect, and d ≈ 0.8 is a large effect with
very significant clinical relevance. Correlations were investigated for each group (postural
kyphosis, Scheuermann’s kyphosis, and normal kyphosis) separately and then as an entire
sample of 160 participants to identify possible differences. SPSS version 20.0 software (SPSS
Inc., Chicago, IL, USA) was used for analyzing data with normality and equal variance
assumptions ensured before the analysis.

3. Results
3.1. Participant Demographics and Characteristics
Descriptive data for the demographic and clinical variables for the entire sample
of 80 hyper-kyphotic and the 80 normal kyphosis participants are presented in Table 1.
No statistically significant differences between the hyper-kyphotic group and the normal
kyphosis group were found at baseline for their demographic and clinical variables. No
data were missing for any of measured variables in any of the participants in this study.
We separated the hyper-kyphotic participants into two groups: 35 postural kyphosis and
45 Scheuermann’s kyphosis categories, and Table 2 presents this demographic and clinical
data. No statistically significant baseline differences for the clinical and demographic
variables was found for these two subgroups of thoracic hyper-kyphosis.

Table 1. Baseline participant demographics. The statistical significance between groups is shown.
Here both the postural and Scheuermann’s kyphosis group are combined into an entire kyphotic
sample. The Student’s t-test to compare the continuous variables and the Chi-squared test for
categorical variables were used. Values are expressed as means ± standard deviation where indicated.

Variables Entire Kyphotic (n = 80) Normal (n = 80) p Value

Age (years) 25.1 ± 3 24 ± 4.6 0.07
Weight (kg) 66 ± 10 60 ± 9 0.9

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Table 1. Cont.

Variables Entire Kyphotic (n = 80) Normal (n = 80) p Value

Sex
Male 38 32
0.2
Female 42 48
Marital status
Single 61 59
Married 19 21 0.3
Separated, divorced, or widowed 0 0
Pain duration (months) 18 ± 4 17 ± 5 0.16
Smoking
Light smoker 29 32
Heavy smoker 14 15 0.4
No Smoker 37 33

Table 2. Participant demographics of the hyper-kyphotic group separated by type of kyphosis with
either a postural kyphosis or a Scheuermann’s kyphosis. Statistical significance was tested using
the ANOVA test to compare continuous variables, and the Chi-squared test for categorical variables.
Values are expressed as means ± standard deviation. * is a statistically significant difference.

Postural Kyphosis Scheuermann’s kyphosis

Variables Normal (n = 80) p Value
N = 35 N = 45
Age (years) 25 ± 3.2 25.3 ± 3 24 ± 4.6 0.16
Weight (kg) 65 ± 11 67 ± 9 60 ± 9 0.6
Sex
Male 18 20 32
0.5
Female 17 25 48
Marital status
Single 27 33 59
Married 8 12 21 0.6
Separated, divorced, or widowed 0 0 0
Pain duration (months) 17 ± 3 18.7 ± 4.5 17 ± 5 0.1
Smoking
Light smoker 15 14 32
Heavy smoker 8 6 15 0.15
No Smoker 12 25 33
Kyphotic angle 66.5 ± 3 67.5 ± 4.9 49 ± 3 <0.001 *

3.2. Between Group Analysis

3.2.1. ICT-ITL (Max)
Box and whisker plots of the ICT-ITL (max) in the two hyper-kyphotic groups com-
pared to the normal group are presented in Figure 4. As designed by our inclusion criteria,
both hyper-kyphotic groups had the largest ICT-ITL (max) angles indicating an exaggerated
kyphotic posture (entire hyper-kyphotic group, 67◦ ± 4; postural kyphosis group, 66.5◦ ± 3;
and Scheuermann’s kyphosis group, 67.5◦ ± 4.9). The normal kyphosis group had the
smallest ICT-ITL (max) angles (normal kyphosis, 49◦ ± 3). As can be seen in Figure 4, there

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was no overlap between the kyphotic angles of the normal and kyphotic groups. Those
with thoracic hyper-kyphosis were well above the threshold of 55◦ , thus eliminating any
overlap within the standard error of measurement of the formetric system.

Figure 4. Box and whisker plots shown of the magnitude of thoracic kyphosis, ICT-ITL (max), in both
hyper-kyphotic groups (postural kyphosis, 66.5◦ ± 3; Scheuermann’s kyphosis; 67.5◦ ± 4.9) and the
normal kyphosis (49◦ ± 3) groups. A statistically significant difference for these variables between
normal kyphosis and total hyper-kyphosis (but not for hyper-kyphosis type) was forced by study
design, where 55◦ (shown as red-dashed line) was the absolute cutoff for kyphosis between groups.

3.2.2. NRS and NDI

For pain level on the NRS, we found no statistically significant differences in pain
intensity between groups (p > 0.05). However, the entire sample of the hyper-kyphotic
group showed an increase in neck disability (NDI) scores compared to the normal kyphosis
group (p < 0.001). When separating the hyper-kyphosis sample into the two subgroups,
we identified a statistically significant difference in the NDI, where the Scheuermann’s
kyphosis group had a higher disability. Tables 3 and 4 presents these results.

Table 3. Between-group comparisons of pain and disability outcomes.

Variables Entire Kyphotic Normal Group (n Cohen’s d p Value

Group (n = 80) = 80) Effect Size (95% CI)

NDI 37.3 ± 4.1 29.8 ± 2.4 2.2 <0.001 *

[−8.5, −6.45]
0.18
Pain intensity 5.3 ± 2.0 4.9 ± 1.8 0.20 [−0.99, 0.19]
CI = confidence interval; NDI = neck disability index; Pain intensity is 0–10 where 0 is no pain and 10 is
incapacitated; all values are expressed as means ± standard deviation. * = statistically significant.

Table 4. Results of one-way-ANOVA and post hoc (Tukey) test. * = statistically significant.

Postural Scheuermann’s Normal Group F-Value/ Post Hoc

Kyphosis N = 35 Kyphosis N = 45 (n = 80) p-Value
Group 1 vs. Group 2: Diff = 3.9,
95% CI = 2.22 to 5.57, p < 0.001 *
NDI 35.2 ± 2.4 39.1 ± 4.5 29.8 ± 2.4 132.67/ Group 1 vs. Group 3: Diff = −5.4,
<0.001 * 95% CI = −6.90 to −3.89, p < 0.001 *
Group 2 vs. Group 3: Diff = −9.3,
95% CI = −10.68 to −7.91, p < 0.001 *
Pain 4.6 ± 1.4 5.9 ± 2.3 4.9 ± 1.8
intensity 2.68/0.07

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3.2.3. Sensorimotor Control Variables

The unpaired t-test analysis showed that there were statistically significant differences
in the hyper-kyphotic group versus the normal kyphosis group for the sensorimotor control
variables. For OSI, we found significant abnormality (less stability) in dynamic stability
for the hyper-kyphotic group compared to the normal kyphosis group (p < 0.001); smaller
values indicate a good stability level of the participants. Larger errors were evident for
right and left rotation repositioning accuracy (p < 0.001) in the hyper-kyphotic group as
well; results are reported as error in degrees (◦ ) where less than 10% or 3◦ is normal. For
SPNT, we found a significant difference between the two groups with a larger average gain
for the hyper-kyphotic group; results are reported as a percentage (%) of error of corrective
saccades, where 100% is perfect (0% error), 10–20% error is normal, and greater than 20%
error is abnormal. Table 5 presents this data.

Table 5. Between group comparisons of the entire sample of the kyphotic group vs. normal group for
sensorimotor control and CVA outcomes.

Kyphotic Normal Cohen’s d p Value

Variables
Group Group Effect Size [95% CI]
<0.001 *
CVA (◦ ) 41 ± 5 53 ± 4 2.65
[10.6, 13.4]
Smooth pursuit neck <0.001 *
0.41 ± 0.17 0.31 ± 0.14 0.6
torsion test (% error) [−0.15, −0.05]
** Overall stability index <0.001 *
0.62 ± 0.2 0.42 ± 0.1 1.26
(refer to methods) [−0.05, −0.14]
Head repositioning <0.001 *
4.0 ± 1.5 3.0 ± 1.2 0.74
accuracy (◦ ) Right [−0.57, −1.42]
Head repositioning <0.001 *
4.3 ± 1.8 3.3 ± 1.5 0.6
accuracy (◦ ) Left [−0.45, −1.58]
Sympathetic skin <0.001 *
2.9 ± 0.9 2.1 ± 0.7 0.87
resistance Amplitude [−0.54, −1.05]
Sympathetic skin 0.07
1.2 ± 0.4 1.3 ± 0.3 0.2
resistance Latency [−0.01, 0.21]
* Denotes statistically significant differences. ** These indices are calculated according to the degree of platform
oscillation; smaller values indicate a good stability level of the participants. CVA = craniovertebral angle. All
values are expressed as means ± standard deviation. CI [] = 95% confidence interval.

Between group comparisons for the postural kyphosis, Scheuermann’s kyphosis and
normal groups are presented separately for sensorimotor control variables and the CVA
in Table 6. Overall, the Scheuermann’s kyphosis group is shown to have statistically and
clinically significant worse sensorimotor control variables. Similarly, the Scheuermann’s
kyphosis group has a statistically significant reduction in the CVA indicating more forward
head posture; p < 0.001, Table 6.

Table 6. Results of one-way-ANOVA and post hoc (Tukey) test. * = statistically significant.

Variables Postural Scheuermann’s Normal F-Value/ Post Hoc

Kyphosis N = 35 Kyphosis N = 45 Group N = 80 p-Value
Group 1 vs. Group 2:
Diff = −5.5, 95% CI = −8.58
to −2.4, p = 0.0002 *
Group 1 vs. Group 3:
CVA (◦ ) 44 ± 4 38.5 ± 4.5 53 ± 4 187.4/
<0.001 * Diff = 9, 95% CI = 5.7 to
12.27, p < 0.001 *
Group 2 vs. Group 3:
Diff = 14.5, 95% CI = 11.3 to
17.6, p < 0.001 *

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Table 6. Cont.

Variables Postural Scheuermann’s Normal F-Value/ Post Hoc

Kyphosis N = 35 Kyphosis N = 45 Group N = 80 p-Value
Group 1 vs. Group 2:
Diff = 0.14, 95% CI = 0.059
to 0.22, p = 0.0002 *
Group 1 vs. Group 3:
Smooth pursuit neck Diff = −0.03,
0.34 ± 0.13 0.48 ± 0.18 0.31 ± 0.14 19.1/<0.001 * 95% CI = −0.10 to 0.04,
torsion test (% error) p = 0.5
Group 2 vs. Group 3:
Diff = −0.17,
95% CI = −0.24 to −0.10,
p < 0.001 *
Group 1 vs. Group 2:
Diff = 0.12, 95% CI = 0.015
to 0.23, p = 0.02 *
Group 1 vs. Group 3:
** Overall stability Diff = −0.14,
index (refer 0.56 ± 0.2 0.68 ± 0.3 0.42 ± 0.1 25.7/<0.001 * 95% CI = −0.23 to −0.045,
to methods) p = 0.0017 *
Group 2 vs. Group 3:
Diff = −0.26,
95% CI = −0.35 to −0.17,
p < 0.001 *
Group 1 vs. Group 2:
Diff = 1.8, 95% CI = 1.14 to
2.5, p < 0.001 *
Group 1 vs. Group 3:
Head repositioning 33.84/
3 ± 0.7 4.8 ± 1.6 3.0 ± 1.2 Diff = 0.0, 95% CI = −0.59
accuracy (◦ ) Right <0.001 *
to 0.59, p = 0.99
Group 2 vs. Group 3:
Diff = −1.8, 95% CI = −2.34
to −1.25, p < 0.001 *
Group 1 vs. Group 2:
Diff = 0.9, 95% CI = 0.02 to
1.77, p = 0.04 *
Group 1 vs. Group 3:
Head repositioning
3.8 ± 2 4.7 ± 1.6 3.3 ± 1.5 10.39/0.04 * Diff = −0.5, 95% CI = −1.29
accuracy (◦ ) Left to 0.29, p = 0.29
Group 2 vs. Group 3:
Diff = −1.4, 95% CI = −2.12
to −0.67, p < 0.001 *
Group 1 vs. Group 2:
Diff = 0.9, 95% CI = 0.48 to
1.31, p < 0.001 *
Group 1 vs. Group 3:
Sympathetic skin
2.4 ± 0.6 3.3 ± 1 2.1 ± 0.7 34.68/<0.001 * Diff = −0.3, 95% CI = −0.67
resistance Amplitude to 0.07, p = 0.14
Group 2 vs. Group 3:
Diff = −1.2, 95% CI = −1.54
to −0.85, p < 0.001 *
Sympathetic skin 1.3 ± 0.3 1.2 ± 0.5 1.3 ± 0.3 NA
resistance Latency 1.19/0.3

* Denotes statistically significant differences. ** These indices are calculated according to the degree of platform
oscillation; smaller values indicate a good stability level of the participants. CVA = craniovertebral angle. All
values are expressed as means ± standard deviation.

3.2.4. SSR Latency and Amplitude

For neurophysiological variables, we found an increase in SSR amplitude in the
entire hyper-kyphotic group compared to the normal kyphosis group (p < 0.001). In
contrast, no such difference was evident for in SSR latency (p = 0.07) as presented in Table 5.
Between group comparisons for the postural kyphosis, Scheuermann’s kyphosis, and
normal groups are presented for SSR latency and amplitude in Table 6. SSR data show
a statistically significant increased amplitude and a faster latency for the Scheuermann’s
kyphosis; however, the latency difference is a rather weak clinically and non-significant
(effect size 0.2; p = 0.29). See Table 5.

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3.3. Correlations
Pearson r correlations between the magnitude of thoracic kyphosis are presented in
Table 7 for both subgroups of thoracic hyper-kyphosis, the normal kyphosis group, and
the entire sample of 160 participants. The kyphotic angle showed a moderate positive
correlation for all sensorimotor control variables (SPNT, OSI, and right and left rotation
repositioning accuracy) with the postural kyphosis group showing significantly greater
correlations than the other groups. We found a moderate positive correlation between the
thoracic kyphotic angle and SSR amplitude for the entire sample of 180 participants (r = 0.69,
p < 0.001), indicating as the kyphotic angles increased, the SSR amplitude increased in our
population. Again, the strongest correlation was found for the postural kyphosis group.
In contrast, we found a low negative correlation between the kyphotic angle and SSR
latency for the entire sample of 180 participants (r = −0.49, p < 0.001), with the smallest
correlation found in the postural kyphosis group. Additionally, pain and disability scores
were moderately linearly correlated to the magnitude of kyphosis in the entire sample
(NRS: r = 0.53, p < 0.001; NDI: r = 0.67; p < 0.001) with the postural kyphosis group showing
slightly stronger correlations than the other participants. Table 7 presents this data in detail.

Table 7. Correlations (Pearson’s r) between the postural kyphosis, the Scheuermann’s kyphosis, the
normal group, and the entire sample for all measured outcomes.

Postural Scheuermann’s Normal Group Entire Sample

Correlation between
Kyphosis r (p Value) Kyphosis r (p Value) r (p Value) r (p Value)
Variables
N = 35 N = 45 N = 80 N = 160
−0.7 −0.6 −0.51 −0.61
CVA
(<0.001) (<0.001) (<0.001) (<0.001)
0.58 0.50 0.51 0.67
NDI
(<0.001) (<0.001) (<0.001) (<0.001)
Pain intensity 0.5 0.35 0.34 0.53
(NRS) (<0.001) (0.03) (0.043) (<0.001)
Smooth pursuit neck 0.54 0.50 0.50 0.58
torsion test (<0.001) (<0.001) (<0.001) (<0.001)
Overall stability 0.61 0.49 0.52 0.59
index (<0.001) (<0.001) (<0.001) (<0.001)
Head repositioning 0.7 0.54 0.61 0.74
accuracy (Right) (<0.001) (<0.001) (<0.001) (<0.001)
Head repositioning 0.67 0.52 0.61 0.71
accuracy (Left) (<0.001) (<0.001) (<0.001) (<0.001)
Sympathetic skin 0.7 0.56 0.61 0.69
resistance amplitude (<0.001) (<0.001) (<0.001) (<0.001)
Sympathetic skin −0.2 −0.5 −0.36 −0.49
resistance latency (0.05) (<0.001) (<0.001) (<0.001)
CVA = Craniovertebral angle; NDI = neck disability index; NRS = numerical rating scale.

Craniovertebral Angle (CVA)

Box and whisker plots of the CVA in both hyper-kyphosis groups (postural kyphosis
and Scheuermann’s kyphosis) and the normal kyphosis group are presented in Figure 5.
Overall, the Scheuermann’s kyphosis group had the smallest CVA indicating greater for-
ward head posture than the other two groups; CVA 38.5◦ ± 4.5. The normal kyphosis group
had the greatest CVA indicating a more neutral sagittal head posture; CVA 53◦ ± 4. These
results were statistically significant (p < 0.001). Lastly, the CVA is negatively correlated with
the magnitude of thoracic kyphosis in all groups, with the strongest correlation found in
the posture kyphosis group, indicating that as the magnitude of thoracic kyphosis increases,

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the CVA decreases and forward head posture increases (entire sample r = −0.061, p < 0.001).
See Table 7.

Figure 5. Box and whisker plots of the craniovertebral angle measured in degrees (CVA◦ ) in the
postural kyphosis groups (CVA, 44◦ ± 4), the Scheuermann’s kyphosis group (CVA, 38◦ ± 4.5), and
the normal kyphosis (CVA, 53◦ ± 4) groups.

4. Discussion
The results of the current study demonstrate that the sensorimotor control, disability,
and autonomic nervous system function of patients with chronic nonspecific neck pain and
thoracic kyphosis are distinctly different compared to those patients with normal thoracic
alignment. Thus, our study’s primary hypotheses are confirmed by these findings. As
far as we know, this is the first study to provide objective evidence that these specific
outcomes are differently affected by altered sagittal thoracic alignment. These differences
cannot be explained in the context of the proposed different pain intensity or pain duration
differences among groups, as the between group analysis revealed a non-significant differ-
ence between groups for both these variables. Most importantly, the difference between
groups appear of clinical importance, as reflected by their effect sizes (d > 0.5) and the
mean differences between groups, which are greater than the minimal clinically important
difference (2.77 × SEM) for the SSR and the NDI outcomes [49–51].

4.1. Thoracic Kyphosis

Thoracic hyper-kyphosis represents one of the top four spine abnormalities associated
with adult spine deformity (ASD), a world-wide, known set of spine deformities and
associated disabilities affecting adults over the age of 18 years [28,29]. For example, Pellise
et al. [28] identified that patients with radiographically determined thoracic hyper-kyphosis
≥60◦ had significantly lower health-related quality of life scores compared to patients af-
flicted with four other major health disorders (type II diabetes, rheumatoid arthritis, heart
disease, or pulmonary disease). There are currently different proposed cut-off values that
distinguish between normal and hyper-kyphosis. For example, 50◦ is suggested by some

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studies as a cut-point for thoracic hyper-kyphosis [30,31], while other investigations have
identified that the cut-point between those with pain, lower self-image, and decreased
function is 45◦ [26,27,52]. In the current investigation, we used a 4-D formetric scanner to
evaluate the external measurement of thoracic kyphosis, and in the hyper-kyphosis group
our average participants’ kyphosis was 67◦ , while it was 49◦ in the normal kyphosis group.
For comparison, it is known that the formetric and inclinometry measures of external
thoracic kyphosis overestimate the radiographic determined thoracic kyphosis by approxi-
mately 5–7◦ and maybe more depending on the unique patient population [33,35,53,54].
Using this information, we estimate that our hyper-kyphosis group had a radiographic
measured thoracic kyphosis averaging 60◦ (depending on the vertebral levels of measure-
ment) meaning that this group would be at the threshold for ASD and that they would
certainly be classified as an abnormal spine deformity group [28,29].

4.2. CVA, Pain, Disability, and Sensorimotor Control

In Table 7, we separated our study’s findings into four separate correlation analyses:
postural kyphosis, Scheuermann’s kyphosis, normal kyphosis, and the entire population.
This was chosen due to the possibility of identifying a stronger correlation between a
specific variable within the hyper-kyphosis groups compared to the normal group. In this
regard, most variables showed stronger correlations within the postural hyper-kyphosis
group compared to the other two populations. It is unclear what this means in terms of
chronic neck pain and neck disability in our study, but it may prove significant in future
investigations. Between group differences in sensorimotor control and neck disability
scores were identified, while there were no differences in pain intensity and duration
between groups. The relationship between pain intensity and thoracic alignment has
been detailed in several studies, where some investigations have reported significant
positive associations, while other studies demonstrated no association between the two
variables [14,55–57]. One such investigation concluded that neck pain was positively
associated with hyper-kyphosis during a functional typing task [58]. These conflicting
results might be due to multiple factors, such as the severity of chronic pain determined by a
variety of other physical and psychosocial contributing factors [59]. Therefore, it is difficult
to predict any linear relationship between thoracic kyphosis and neck pain intensity. Since
the differences in disability and sensorimotor control found between our hyper-kyphosis
and normal groups are not due to differences in pain intensity or pain duration, we propose
the possible mechanism driving these changes might be dysafferentation mediated by
abnormal forward head malalignment and increased thoracic kyphosis.
Increased thoracic kyphosis leads to the anterior shift of the trunk mass through an
alteration of the thoracic spine loading, thereby resulting in forward head posture of the
cervical spine as a direct compensation [14]. This has been confirmed in the current study
by the fact that the mean CVA for the kyphotic group was significantly lower than that
of the control (non-kyphotic) group indicating considerably larger forward head posture
in the kyphotic group. Sustained forward head posture is implicated in the alteration of
cervical motor control and the development of myofascial dysfunction. The assumption
that abnormal forward head posture alignment is important for the afferentation process
has some preliminary evidence. For instance, two modeling studies have predicted that as
forward head posture increases, increased stress and strain are placed upon the muscles
and ligaments of the cervical and thoracic region [60–62]. Increased forward head posture
results in altered cervical spine alignment and shoulder joint position, causing abnormal
kinematics and neurophysiologic afferent input (the so-called dysafferentation) [63–65]. We
suggest that this information is consistent with and may partially explain the findings from
Stanton and colleagues [66], where chronic idiopathic neck populations were identified
to have an abnormal ability to return the cervical spine to the neutral position (altered
sensorimotor control).
In the current investigation, it is difficult to discern between the effects of increased
forward head posture (the CVA) versus increased thoracic kyphosis on the variables we

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have assessed, and conflicting results have been reported in the literature regarding the
significance of sensorimotor control measures in neck pain populations. For example, in
a recent systematic review with meta-analysis, it was found that increased forward head
posture is associated with the presence of neck pain in adults [67,68]. However, Pacheco
and colleagues [68] found that forward head posture was not different between young
collegiate adults with ”subclinical neck pain” compared to asymptomatic controls. This
later investigation [69] used a very different participant population in both age (college
students only 18–22 years) and a non-clinically relevant pain condition (treatment was not
sought) as compared to our current investigation (significantly older and participants were
seeking intervention from our pain clinic); thus, we believe our results to be more in line
with the two recent systematic reviews with meta-analysis [67,68].
A significant negative correlation was found in the current study between the magni-
tude of thoracic kyphosis and a participant’s CVA. This finding was previously reported in
the study by Quek et al. [13]. Moreover, a multitude of biomechanics analysis have revealed
that increased forward head posture along with thoracic hyper-kyphosis is associated with
mobility limitations in the cervical spine [15]. Given the preliminary evidence for the signif-
icant role of normal sagittal configuration in normalizing the afferentation processes, it is
not surprising that there was a considerable between group difference in the sensorimotor
control variables. The current study’s findings of increased disability and more disturbed
sensorimotor control add credence to the above biomechanics and clinical investigations
detailing the effects of thoracic spine abnormalities on the cervical spine. The relationship
between increased forward head posture, that is, a smaller CVA, and thoracic kyphosis
has been investigated in previous studies [14,15]. Lau et al. [14] reported a smaller CVA in
participants with neck pain compared to a healthy control group. Lau et al. [14] suggested
that a smaller CVA and upper thoracic angle were thought to be predictors of neck pain and
disability in terms of their participants pain intensity. However, in the current study, it was
not surprising that there were no significant variations in pain intensity between our two
groups, because pain is a multidimensional phenomenon affected by many factors other
than sagittal alignment. Moreover, symptoms caused by abnormal spine biomechanics
likely appear after the consequences of mechanical distortions have progressed to the point
where the body’s adaptive ability has been overcome (as is the case with heart disease,
cancer, hypertension, etc.). Since the participants in our study were much younger than
those in the other study [14], the age differences between the two studies could explain
the disparity in pain intensity findings. Interestingly, although the different postural align-
ments between our groups had no effect on pain intensity, it had a significant impact
on the other measurement outcomes, as shown by the strong correlation between spinal
alignment and those outcomes (disability, sensorimotor control measures, and sympathetic
skin resistance). Our finding is consistent with that of Moustafa et al., who found that even
in asymptomatic individuals with a forward head posture, there are significant abnormal
neurophysiological responses, including prolonged central conduction time and abnormal
sensorimotor integration [70].

4.3. SSR
Our choice of the sympathetic skin response (SSR) as an indicator for autonomic
nervous system (ANS) function in the current study instead of other measures such as
heart rate variability (HRV) measurement might by questioned. HRV is a commonly used
and standardized method for assessing ANS function, as it provides separate metrics for
sympathetic and parasympathetic functions through the low-frequency (LF) and high-
frequency (HF) spectral components of HRV. However, recent studies have shown that
the traditional HRV framework established in the 1980s has limitations in dealing with
the evidence accumulated over the past half-century. As pointed out by Hayano and
Yuda [71], using HRV without criticism may lead to incorrect conclusions or judgments.
Moreover, a study by Ke et al. [72] has shown that both SSR and HRV parameters are
sensitive in determining ANS dysfunction. Therefore, we chose SSR as an alternative and

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easily assessed measure for ANS function in our study. We acknowledge that HRV may
provide additional information about ANS function, and future studies should use this
to assess the influence of thoracic kyphosis and increasing FHP on HRV. However, our
current findings using SSR highlight the potential clinical value of this measure in assessing
ANS dysfunction.
We believe that a significant between group difference in SSR indicates the consider-
able role of spinal sagittal alignment in maintaining the normal function of the autonomic
nervous system. Oakley et al. [73] detailed information indicating that restoring normal
posture and spine alignment has important influences on neurophysiology, sensorimo-
tor control, and autonomic nervous system function. There is limited but high-quality
research identifying that sagittal spine alignment restoration plays an important role in
improving neurophysiology, sensorimotor control, and autonomic nervous system func-
tion [73,74]. Disturbances in the afferentation process may be the possible explanation
underpinning spine-related autonomic dysfunction. An adverse mechanical tension acting
on the brainstem and cranial nerves 5–12, specially the 10th cranial nerve, may be one
of the fundamental mechanisms that explain the autonomic dysfunction in the kyphotic
group compared to the control group.

4.4. Clinical Relevance

Clinically, our study findings would implicate the thoracic hyper-kyphosis as a con-
tributing factor in the disability levels reported in chronic non-specific neck pain disorders.
We identified that increased FHP (a decreased CVA) is corelated to the magnitude of tho-
racic kyphosis. Since it is known that increasing FHP causes a simultaneous increased
loading of the upper thoracic and lower cervical spine, it would be logical that this increased
loading affects the ability of a person’s cervical spine to perform complex and simple tasks
that create further functional demands on the spine tissues [60,61]. Furthermore, increased
FHP alters both the total range of motion and segmental kinematics of the cervical spine
during movements, and this would further exacerbate cervical spine pain and create limits
to functional movements as a result [13–15]. Similarly, the general results of our sensorimo-
tor control assessments indicate that participants with increased thoracic kyphosis have a
generally poorer ability to perform efficient tasks requiring stability (balance), movement
accuracy (HRA), and ocular motor control (SPENT). The findings of inefficient sensorimotor
control would have significant implications for continued injury (increased and altered
stresses and strains on various spine tissues) of a participants cervical spine tissues, where
a vicious cycle is set up of spine tissue damage due to inefficient motor control or coordi-
nation of movement. In general, our findings would suggest that structural rehabilitation
(rehabilitation aimed at improving spine alignment) of the hyper-kyphotic spine should
be a primary goal of patient treatment procedures. In fact, in a recent randomized trial, it
was identified that structural rehabilitation of the thoracic hyper-kyphosis had positive
effects on improving chronic non-specific neck pain, disability, and sensorimotor control as
compared to standard rehabilitative care that did not improve the alignment of the thoracic
hyper-kyphosis [74].

4.5. Limitations
The current study has limitations to consider which should lead to future investiga-
tions. First, the outcome measures used to verify if thoracic kyphosis affects sensorimotor
control, pain, and disability may not be the only ones or the ideal assessment for chronic
neck pain outcomes. Additionally, we measured the thoracic kyphosis using an exter-
nal posture assessment device, and this does not provide the same quantitative data as
radiographic or other imaging methods used for the measurement of thoracic kyphosis.
Similarly, although the CVA is a valid and reliable method for measuring forward head
alignment [14,36,37], it might not adequately describe the actual sagittal cervical vertebral
alignment. Using the sagittal radiological profile would thus give further insights into
exact rotation and translation displacements of individual vertebral and overall cervical

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curvature geometry and magnitude. Furthermore, our study did not include a true normal
control group without chronic non-specific neck pain and a normal thoracic kyphosis;
thus, comparison to populations without chronic non-specific neck pain cannot be made.
Finally, although we demonstrated that increasing kyphotic magnitudes of the thoracic
spine are correlated with sensorimotor control measurements and the autonomic nervous
system function, it must be emphasized that correlation does not imply causation. Future
investigations that are prospective and longitudinal in design along with randomized
interventional trials are needed to confirm the relationship between the magnitude of
thoracic hyper-kyphosis and the measures reported herein.

5. Conclusions
This case control on a chronic non-specific neck pain population identified that those
with thoracic hyper-kyphosis also have an increased forward head posture (reduced CVA)
and that this is related to abnormal autonomic nervous system function. Furthermore,
increased thoracic kyphosis is correlated to disturbances of a variety of sensorimotor
control measures. Our findings may have important implications for the assessment and
rehabilitation of these populations of patients with hyper-kyphosis of the thoracic spine,
increased forward head posture, and chronic non-specific neck pain.

Author Contributions: Conceptualization, I.M.M., T.S., A.A., D.E.H.; methodology, I.M.M., T.S., A.A.,
D.E.H.; software, I.M.M., T.S., A.A.; validation, I.M.M., T.S., A.A., D.E.H.; formal analysis, I.M.M.,
T.S., A.A., D.E.H.; investigation, I.M.M., T.S., A.A.; resources, I.M.M., T.S., A.A.; data curation, I.M.M.,
T.S., A.A.; writing—I.M.M., T.S., A.A., D.E.H.; I.M.M., T.S., A.A., D.E.H.; visualization, I.M.M., T.S.,
A.A., D.E.H.; supervision, I.M.M., T.S., A.A.; project administration, I.M.M., T.S., A.A. All authors
have read and agreed to the published version of the manuscript.
Funding: This research received no external funding.
Institutional Review Board Statement: The study was conducted in accordance with the Declaration
of Helsinki. Ethical approval was obtained from the Research and Ethics Committee at Cairo
University (CA-REC-22-5-20), with informed consent obtained from all participants prior to data
collection in accordance with relevant guidelines and regulations.
Informed Consent Statement: Written informed consent was obtained from all subjects involved in
the study.
Data Availability Statement: Data supporting reported results can be ascertained by emailing the
lead author of this study: Professor Ibrahim Moustafa at [email protected].
Conflicts of Interest: Dr. Deed Harrison (DEH) lectures to health care providers on rehabilitation
methods and is the CEO of a company that sells products to physicians for patient care to aid in
improvement of postural and spine ailments as described in this manuscript. All other authors
declare no conflict of interest related to this project.

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 Journal of
Clinical Medicine

Article
An Investigation of the Association between 3D Spinal
Alignment and Fibromyalgia
Amal Ahbouch 1 , Ibrahim M. Moustafa 1,2,3 , Tamer Shousha 1,2,3 , Ashokan Arumugam 1,2 , Paul Oakley 4,5,6 and
Deed E. Harrison 4, *

1 Department of Physiotherapy, College of Health Sciences, University of Sharjah,

Sharjah 27272, United Arab Emirates
2 Neuromusculoskeletal Rehabilitation Research Group, RIMHS–Research Institute of Medical and Health
Sciences, University of Sharjah, Sharjah 27272, United Arab Emirates
3 Faculty of Physical Therapy, Cairo University, Giza 12613, Egypt
4 CBP Nonprofit (a Spine Research Foundation), Eagle, ID 83616, USA
5 Private Practice, Newmarket, ON L3Y 8Y8, Canada
6 Kinesiology and Health Sciences, York University, Toronto, ON M3J 1P3, Canada
* Correspondence: [email protected]; Tel.: +1-775-340-4734

Abstract: Fibromyalgia syndrome (FMS) is a common condition lacking strong diagnostic criteria;
these criteria continue to evolve as more and more studies are performed to explore it. This investiga-
tion sought to identify whether participants with FMS have more frequent and larger postural/spinal
displacements in comparison to a matched control group without the condition of FMS. A total of
67 adults (55 females) out of 380 participants with FMS were recruited. Participants with FMS were
sex- and age-matched with 67 asymptomatic participants (controls) without FMS. We used a three-
dimensional (3D) postural assessment device (Formetric system) to analyze five posture variables in
each participant in both groups: (1) thoracic kyphotic angle, (2) trunk imbalance, (3) trunk inclination,
(4) lumbar lordotic angle, and (5) vertebral rotation. In order to determine whether 3D postural
measures could predict the likelihood of a participant having FMS, we applied the matched-pairs
binary logistic regression analysis. The 3D posture measures identified statistically and clinically
significant differences between the FMS and control groups for each of the five posture variables
Citation: Ahbouch, A.; Moustafa,
measured (p < 0.001). For three out of five posture measurements assessed, the binary logistic re-
I.M.; Shousha, T.; Arumugam, A.;
Oakley, P.; Harrison, D.E. An
gression identified there was an increased probability of having FMS with an increased: (1) thoracic
Investigation of the Association kyphotic angle proportional odds ratio [Prop OR] = 1.76 (95% CI = 1.03, 3.02); (2) sagittal imbalance
between 3D Spinal Alignment and Prop OR = 1.54 (95% CI = 0.973, 2.459); and (3) surface rotation Prop OR = 7.9 (95% CI = 1.494, 41.97).
Fibromyalgia. J. Clin. Med. 2023, 12, We identified no significant probability of having FMS for the following two postural measurements:
218. https://doi.org/10.3390/ (1) coronal balance (p = 0.50) and (2) lumbar lordotic angle (p = 0.10). Our study’s findings suggest
jcm12010218 there is a strong relationship between 3D spinal misalignment and the diagnosis of FMS. In fact, our
Academic Editors: Hideaki Nakajima
results support that thoracic kyphotic angle, sagittal imbalance, and surface rotation are predictors of
and Antonio Barile having FMS.

Received: 7 October 2022 Keywords: fibromyalgia; posture; prediction; regression analysis; formetric analysis
Revised: 5 December 2022
Accepted: 25 December 2022
Published: 28 December 2022

1. Introduction
Fibromyalgia syndrome (FMS) is a prevalent musculoskeletal condition that man-
Copyright: © 2022 by the authors. ifests with pain, stiffness, and tenderness of different body structures, such as muscles
Licensee MDPI, Basel, Switzerland. and tendons. Characteristic symptoms of FMS include general malaise with anxiety and
This article is an open access article depression, poor sleep, cognitive dysfunction, and disturbances in bowel functions [1,2].
distributed under the terms and FMS is underdiagnosed and undertreated due to the complexity of the multiple symptoms
conditions of the Creative Commons and comorbidities associated with it [3]. Despite the many efforts that have been made with
Attribution (CC BY) license (https://
specific diagnostic criteria for FMS, healthcare providers still find these criteria unclear,
creativecommons.org/licenses/by/
which causes a lack of confidence when using them [3,4]. In fact, these criteria have required
4.0/).

J. Clin. Med. 2023, 12, 218. https://doi.org/10.3390/jcm12010218 https://www.mdpi.com/journal/jcm

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multiple revisions as more and more data were made available. Despite elimination of the
associated symptoms criterion in the 1990 classification and the tender points examination
in the 2010/2011 revision, the 2016 revision included these two criteria [4].
Despite the debate around the FMS diagnostic criteria, it is well-established that
pain is a centrally mediated phenomenon [2,4–6]. Currently, the evidence conceptualizes
pain as the personal experience of a complex process compiling sources of input from
joint mechano-receptors and information from the general environment, coupled with
previous painful experiences and or memories of a painful event [6]. In fact, evidence
has linked pain to posture and supported that moderation or elimination of pain can
be achieved through improved posture [7,8]. While this association between pain and
postural alignment has been questioned by other studies [9,10], the evidence supporting
it is constantly growing [7]. For example, evidence supports a strong link between body
misalignment and pain syndromes, many of which are found in FMS patients, including:
tension-type and cervico-genic headaches [11,12], temporomandibular disorders [13–15],
shoulder impingement [16,17], abnormal sagittal plane postures like protracted shoulders
and forward head posture, respiratory dysfunction [18,19], back pain [20,21], impaired
balance [22], FMS itself [23], and osteoporotic spinal deformity [24].
Determining objective postural assessment outcome measures could add another
dimension to the diagnostic criteria of FMS, leaving less room for doubt for healthcare
providers in diagnosis, and guiding more robust interventional treatments. The objective of
the current investigation is to examine the potential relationship between FMS and postural
misalignment, through detailed measurement of three-dimensional (3D) posture including
kyphotic and lordotic angles, sagittal and coronal imbalance, and vertebral rotation. We
designed a case control investigation to explore any postural diagnostic relationships that
might predict cases with FMS versus those controls without FMS in an effort to help with
diagnosing and treating this complex condition. The current study explores the hypothesis
that 3D postural analysis will be able to accurately determine FMS participants compared
to matched healthy controls.

2. Materials and Methods

We used a single-blind case control design to assess possible differences in 3D postural
alignment among participants with chronic FMS in comparison to an age- and sex-matched
asymptomatic control group. All ethical standards for use in human experimental research
designs were followed in compliance with the Helsinki Declaration. Participant recruit-
ment began following an approval from the Cairo University Ethics Committee (approval
number: Cairo-PT.3-4561). Participants were recruited via advertisements posted on notice
boards and relevant social media pages.
Initial inclusion criteria were assessed via a screening phone call for potential partic-
ipants, and those with suspected FMS were then scheduled for and received a detailed
evaluation with one of three neurologists working at our outpatient department to confirm
their eligibility to participate. The asymptomatic control group comprised of volunteers
who received the same examination and assessments using a therapist who was blind to
the participants’ possible group status (control vs. FMS). In order to be eligible for the
control group, participants were required to be asymptomatic and could not report pain
during the physical examination process. All participants signed informed consent forms
prior to entering the investigation and also prior to data collection.
Sixty-seven adult participants with FMS (≥18 years of age, 12 males and 55 females)
out of 380 participants were enrolled after meeting the 2016 fibromyalgia diagnostic cri-
teria [4]. All participants were screened for conditions that would affect their inclusion
into our study: severe cardiopulmonary disease and hyper-tension, long-standing viral
infections, a history of any significant medical condition, any moderate or severe scoliosis,
and a history of spine surgery.

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2.1. 3D Posture Measurement Using a Formetric System

The Formetric software system (DIERS Medical Systems, Chicago, IL, USA) was used
to provide analysis of the following posture profiles in three planes: (1) sagittal plane pa-
rameters (kyphotic angle, lordotic angle, and sagittal imbalance); (2) frontal/coronal plane
parameters (coronal imbalance); (3) and transverse plane parameters (vertebral rotation).
This system is both valid and reliable for postural measurements as used herein [25,26]. We
followed previously published standard protocols for patient positioning, measurements,
and data acquisition for Formetric software analysis, and we refer the interested reader to
this publication [12]. A sample Formetric system report is shown in Figure 1 and each of
these measurement variables is described below.

Figure 1. Illustrative example for the Formetric report.

2.2. Kyphotic Angle

The thoracic kyphotic angle (cervicothoracic transition point (ICT)- thoracolumbar
transition point (ITL) max) was measured between tangents from the cervicothoracic
junction (ICT-T1) and that of the thoracolumbar junction (ITL-T12). The cutoff value to
determine hyper-kyphosis of our participants was set at an angle greater than or equal
to 55◦ [25,27]. Formetric measurements of thoracic kyphosis over-estimate the actual
radiographic measured kyphosis of the same person by a mean of 7–8◦ ; however, a strong
correlation between the two different measurement methods has been found (r = 0.79 to
0.872) [25,27]. Thus, a formetric value of 55◦ for thoracic kyphosis would approximate a
48◦ radiographic measurement value from T1–T12 (the upper end of normal in healthy
middle-aged adults) [28].

2.3. Lordotic Angle

The lumbar lordotic angle was assessed between the intersection of two lines drawn
tangent to: (1) a surface marker at the inflection point of the thoraco-lumbar junction
(termed ITL) and (2) the point of inflection between the lumbar and sacral spines (termed
ILS) and the maximum lumbar lordosis was thus termed ITL-ILS max. The Formetric
measurement of lumbar lordosis is both reliable and valid with a good correlation (r > 0.70)
to radiography and small measurement differences (8◦ difference from radiographic mea-
surements) [25,27].

2.4. Sagittal Imbalance or Trunk Inclination

Sagittal imbalance was measured as a height difference between the vertebral promi-
nence of C7 (VP) and dimple middle (DM), defined as the point lying on the center of

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the straight line connecting the left dimple to the right dimple, based on a vertical plane
(sagittal section). When the VP is anterior relative to the DM, then the angle has a positive
value, while if the VP is posterior to the DM, then the angle has a negative value.

2.5. Coronal Imbalance

The coronal imbalance of the trunk is measured as the left and right displacement of
the VP relative to a DM lying in the center of a straight line that connects the left and right
dimples. A positive shift is indicated by the VP offset to the right while a negative shift is
directed to the left.

2.6. Vertebral Rotation

The vertebral rotation is measured as the root mean square (RMS) of the horizontal
components of the surface normal relative to a line of symmetry.

2.7. Fibromyalgia Impact Questionnaire (FIQ)

Our primary outcome to determine the relationship between 3D posture displacements
and FMS was whether or not posture displacements variables would correlate to the
fibromyalgia impact questionnaire FIQ score of the FMS participants. The FIQ is a patient
questionnaire designed to quantify the impact of FMS on a participant’s current status, their
progress or response to intervention. The FIQ is valid and reliable and has 10 subscales that
include: physical, day missed from work, ability to perform job duties, well-being, pain
intensity, fatigue or malaise, sleep quality, generalized stiffness, and depression and anxiety.
The FIQ is scored from 0–100 with greater scores indicating more disability or impairment
due to FMS [29].

2.8. Sample Size Determination

A pilot study consisting of 10 participants with FMS compared to 10 age- and sex-
matched controls was performed, and this data was used to identify the sample size of
participants needed for statistical findings. The mean differences and SD of the posture
parameters; kyphotic angle, lordotic angle, sagittal imbalance, coronal imbalance; vertebral
rotation were: kyphotic angle: −12 (SD 6.2), lordotic angle: –4 (SD 4.8), –sagittal imbalance:
–5.2 (SD 2.1) coronal imbalance: –4 (SD 1.9), vertebral rotation: –3.9 (SD 1.8). We applied
a Bonferroni correction to adjust the significance value for each of the primary outcomes.
Using the largest value of the needed sample size estimate determined the final sample
size for our trial. It was determined that 56 participants in each group (with a statistical
power of 90%) was necessary herein; we increased the sample size by 20% to account for
possible participant dropouts.

2.9. Data Analysis

In order to test normality of the distribution of our data, we used a one-sample
Kolmogorov–Smirnov normality test. Where the data are normally distributed, they are
presented as mean ± standard deviation (SD). Baseline participant demographics of age,
weight, body mass index (BMI), highest education level completed, marital status, and
pain duration, were compared between both groups using the independent t tests for
continuous data and chi square tests of independence for categorical data. The Student’s
t-test was used to compare the means of continuous variables between the two groups. A
p-value of < 0.05 was considered statistically significant. A matched-pairs binary logistic
regression procedure for estimating odds ratios for a matched pairs case-control design
determined whether the 3D posture parameters (kyphotic angle (ICT-ITL (max)), lordotic
angle (ITL-ILS (max)), sagittal imbalance (VP-DM), coronal imbalance (VP-DM), and ver-
tebral rotation (RMS)) demonstrated an association with the likelihood of experiencing
FMS. Multiple regression was carried out to examine whether posture parameters could
significantly predict FMS participants’ FIQ scores. SPSS version 20.0 software was used for
analyzing data (IBM SPSS Inc., Armonk, NY, USA).

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3. Results
We screened by phone greater than 380 possible participants. The most often reason for
participant exclusion was an uncontrolled medical condition such as diabetes mellitus, heart
disease, renal failure, and so forth. A hierarchy of control group participant was applied
whereby a control participant was only included after a FMS group participant of a similar
age and gender had been recruited, thus, further exclusions occurred when matching was
not possible. Included group participants were: (1) FMS (mean age 46.4 years, SD = 9;
12 males, 55 females) and (2) 67 sex and age matched controls (mean age = 46.5 years,
SD = 9.1; 12 males, 55 female). Figure 2 demonstrates the participants’ inclusion and
exclusion flow chart for this study.

Figure 2. Participant flow chart.

3.1. Sample Characteristics

The baseline participant demographics are presented in Table 1. The FMS and control
groups were statistically matched for each of the included demographic variables (Table 1).

Table 1. Baseline participant demographics.

Variable Fibromyalgia Group (n = 67) Control Group (n = 67)

Age (years) 46.4 ± 9 46.5 ± 9.1
Weight (kg) 75 ± 9 80 ± 10
Gender (%)
Male 12 12
Female 55 55
Body mass index mean (SD), Kg/m2
Graduation
Primary school 5 (7.5%) 2 (3%)
Secondary school 10 (14.9%) 8 (11.9%)
Advanced technical colleague certificate 10 (14.9%) 15 (22.4%)
University diploma 32 (47.8%) 30 (44.8%)
Others 10 (14.9%) 12 (17.9%)
Marital status (%)
Single 5 (7.5%) 4 (6%)
Married 55 (82.1%) 57 (85%)
Separated, divorced, or widowed 7 (10.4%) 6 (9%)
Pain duration
1–5 y 20 (29.9%) Asymptomatic
>5 y 47 (70.1%) Asymptomatic
There were no statistically significant differences between the FMS and control groups; p > 0.05 for all variables
using the independent t test for continuous data and chi squared test of independence for categorical data. y: year.

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3.2. Formetric Postural Variables between Group Differences

Each of the five postural variables were found to be statistically significant different
between both groups: kyphotic ICT-ITL (max) (p < 0.001); lordotic angle ITL-ILS (max)
(p < 0.001); sagittal imbalance (p < 0.001); coronal imbalance (p < 0.001); and vertebral
rotation (rms) (p < 0.001). Table 2 reports the 3D Formetric data means and SD between the
FMS and control groups.

Table 2. Means, standard deviation (SD), 95% confidence interval (CI) and statistical significance of
the postural measurements between participants with FMS and controls.

3D Formetric Measurement Mean ±SD SEM Cohen’s d 95% CI p-Value

FMS 74.1 4.75 0.58
Kyphotic angle ICT-ITL (max) (deg.) 6.8 [14.3–19.04] <0.001
Control 57.4 8.41 1.02
FMS 45.1 5.71 0.69
Lordotic angle ITL-ILS (max) (deg.) 4.3 [1.9–4.9] <0.001
Control 41.5 2.46 0.30
FMS 9.53 2.77 0.33
Sagittal imbalance (mm) 2.3 [4.1–5.7] <0.001
Control 4.5 1.89 0.23
FMS 8.04 3.19 0.39
Coronal imbalance (mm) 2.4 [3.6–5.6] <0.001
Control 3.22 1.37 0.16
FMS 9.5 1.86 0.22
vertebral rotation (rms) (deg.) 1.8 [3.5–4.7] <0.001
Control 5.3 1.75 0.21
SEM: Std. Error of Mean; SD: standard deviation; CI: confidence interval; ICT-ITL: Cervico-thoracic inflection
point-thoraco-lumbar inflection point; ITL-ILS: thoracic-lumbar inflection point- lumbo-sacral inflection point;
rms: root mean square.

3.3. Binary Logistic Regressions

The binary logistic regression analysis identified a statistically significant increased
probability of having FMS as the following postural variables become increasingly abnor-
mal: (1) kyphotic angle ICT-ITL (max) (p < 0.03), (2) sagittal trunk imbalance (p = 0.005),
and (3) vertebral rotation (rms) (p = 0.015). In contrast, no statistically significant differences
were found for the two remaining postural displacement variables of coronal balance
(p = 0.50) and lumbar lordotic angle (ITL-ILS (max); p = 0.10). See Table 3.

Table 3. Variables in the equation for logistic regression and odds ratio calculation.

Variables in the Equation

95% CI for EXP(B)
B S.E. Wald df Sig. Exp(B)
Lower Upper
Sagittal imbalance (mm) 0.437 0.236 3.409 1 0.005 1.547 0.973 2.459
vertebral rotation (rms) (degrees) 2.069 0.851 5.914 1 0.015 7.919 1.494 41.970
Kyphotic ICT−ITL (max) (degrees) 0.569 0.275 4.273 1 0.039 1.766 1.030 3.029
Coronal imbalance (mm) −0.188 0.313 0.360 1 0.549 0.829 0.449 1.530
Lordotic angle (degrees) 0.472 0.326 2.105 1 0.147 1.604 0.847 3.035
Constant −52.309 21.782 5.767 1 0.016 0.000
Variable(s) entered on step 1: Sagittal imbalance, vertebral rotation, Kyphotic ICT-ITL (max), Coronal imbalance,
Lordotic angle.

3.4. Odds Ratios between Having FMS and Posture Variables

Three of the five postural displacement variables were found to have statistically
significant odds ratios identifying an increased risk of having FMS with increases in the
magnitude of the abnormal posture. These three postural variables and their odds ratios

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were: (1) Thoracic kyphotic angle = 1.76 (95% CI = 1.03, 3.02) indicating that for each degree
of increased angle, there was an approximate 76% increased likelihood of having FMS;
(2) Sagittal imbalance = 1.54 (95% CI = 0.973, 2.459) indicating that for each degree increase
of sagittal imbalance, there was an approximate 54% increased likelihood of having FMS;
(3) Surface rotation = 7.9 (95% CI = 1.494, 41.97) indicating that with each 7 degrees increase
in surface rotation, there was an approximate 90% increased likelihood of having FMS in
this sample.
Similarly, multiple linear regression analysis identified that the 3 postural displace-
ment variables (thoracic kyphotic angle, sagittal imbalance, and vertebral surface rotation)
were statistically significant predictors of a participant’s FMS impact questionnaire scores;
F = 104.4, p < 0.01. The multiple-regression analysis revealed that 80% of the variance
in the dependent variable FMS impact questionnaire scores could be explained by the
independent variables (postural displacements). Table 4 presents these findings.

Table 4. Multiple linear regression for the fibromyalgia impact questionnaire score versus postural
variables and their associated risk factors.

Unstandardized Standardized 95.0% Confidence

Coefficients Coefficients Interval for B
Model t Sig.
Lower Upper
B Std. Error Beta
Bound Bound
Constant −2.043 0.214 −9.562 <0.001 −2.466 −1.620
Kyphotic ICT−ITL (max) (deg.) 0.021 0.003 0.459 8.462 <0.001 0.016 0.026
sagittal imbalance (mm) 0.024 0.009 0.166 2.739 0.005 0.007 0.042
1
vertebral rotation (deg.) 0.078 0.011 0.430 7.197 <0.001 0.057 0.099
Lordotic angle (deg.) 0.010 0.004 0.092 2.206 0.029 0.001 0.019
Coronal imbalance (mm) −0.007 0.010 −0.046 −0.688 0.493 −0.026 0.013
B: Unstandardized coefficients.

4. Discussion
This case control investigation sought to identify if 3D posture displacements can iden-
tify FMS participants versus a matched control group without overt signs and symptoms
and no FMS. The results identified from this study show that there is a strong relationship
between spinal 3D misalignment and the diagnosis of FMS. In fact, our results support that
the outcome measures used to objectively assess thoraco-lumbar postural alignments could
be used as strong predictors for the diagnosis of FMS. We believe that our investigation
is the first study to seek and identify a predictive association between comprehensive 3D
thoraco-lumbar postural alignments and FMS.
Some recent studies investigated spine posture in individuals, commonly women,
with FMS [30–33]. Sempere-Rubio et al. [30] found that there is an altered trunk posture
in women with FMS compared to a control group. These findings agree with those of
the current study; both studies found differences in the same direction for one of the
most common outcome measures; namely an increased kyphotic angle of the group with
FMS [30]. However, our study offers other more objective outcome measures for the posture
assessment by using the 3D Diers Formetric device. Another study by Sempere-Rubio et al.
showed that women with FMS have an altered postural control compared to a healthy
group, adding to the strong factors that should be considered in diagnosing and treating
FMS [31].
The increased thoracic kyphosis in FMS populations has also been supported by
Celenay et al. [33], who found that women with FMS had an increased thoracic kyphosis
angle compared to the control group. However, the lumbar lordosis was not significantly
different between groups while in our study the group with FMS had a slightly higher
lumbar lordotic angle compared to the control group. This discrepancy for lumbar lordosis

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between investigations is likely explained by the fact that the compensation to an increased
kyphotic angle (which is the confirmed common deviation in all the studies mentioned
including our study) can be either an increased or a decreased lordotic angle depending
on the general posture assumed by the individual [34]. The increased kyphosis in the
kyphotic, flat-back and sway-back postures is linked to neutral lumbar spine, hypolordotic
upper lumbar spine and a hyperlordotic lower lumbar spine in each of those three postures,
respectively [34].
Although a normal clinical neurological examination is most often identified, FMS
patients consistently report sensory deficits which has been confirmed on dynamic pos-
turography [35,36]. Indeed, abnormalities of body posture in women suffering from
FMS have been identified to be related to poor trunk position sense and balance instabil-
ity [33]. Sempere-Rubio et al. identified that females with FMS have poorer postural control
compared to a healthy group which further emphasizes including postural alignment in
diagnosing and treating FMS [31]. Another study by Sempere-Rubio et al. reported that a
decreased ability in maintaining sitting thoracic posture could predict a reduction in quality
of life in women with FMS [32].
Previously, investigators have suggested that objective studies are needed to under-
stand postural balance abnormalities in FMS populations and their relationship to different
types of musculoskeletal abnormalities [37]. The relationship between FMS and postu-
ral misalignment has been investigated in several studies [7,38–40]. Moustafa and Diab
speculated that sustained postural imbalances can result in the establishment of a state of
continuous asymmetric loading [38]. If a significant maladaptive posture is sustained long
enough, it will consequently affect the quality of life [41]. These speculations are supported
by other authors [42,43] who discuss that biomechanical dysfunction causing a sustained
asymmetrical loading and muscle imbalance leads to an increased stress and strain on body
structures. For instance, Hiemeyer et al. linked poor flexed posture to the tender points
characterizing FMS, most of which are in postural muscles [43]; restoring a correct posture
diminished these tender points if not completely eliminated them [43,44].
The most intriguing finding was that the predictors of postural features included not
only the sagittal profile, but also the abnormal transverse profile as indicated by surface
rotation. This finding is not surprising as previously, Veldhuizen et al. [45] identified that
alterations in transverse plane rotational alignment were positively correlated to sagittal
alignment abnormalities. Similarly, other authors have reported the correlation between the
sagittal and coronal and transverse spinal contours [46–48]. Incorrect posture and spinal
abnormalities in sagittal and axial planes may modify the stability of this structure and
its load distribution, which can generate abnormal stresses and strains, thus provoking a
reduction in quality of life and an increased risk of FMS.
The present paper adds to the present body of FMS literature that supports an optimal
alignment of upright human posture. Due to the significant relationships between the
magnitude of the posture displacements as identified with the Formetric analysis and the
odds of having FMS our findings indicate that postural displacements are predictive of not
only who has fibromyalgia but also of the severity of the identified disability as measured
with the FIQ. Our findings are in general agreement of the randomized trial by Moustafa
where it was identified that correction of the cervical sagittal plane alignment was found
to improve 3D posture and improve the short- and long-term pain and impairments of
patients suffering from chronic FMS [44].

4.1. Limitations
Because this study was a cross-sectional, case-control investigation and not a treatment
outcome trial, it is unknown how our findings may or may not influence patient treatment
outcomes when postural rehabilitation is pursued. However, since the 3D postural analysis
showed increased posture aberrations in the FMS group, we recommend that interven-
tions designed to improve 3D posture should be implemented as part of a multi-modal
treatment approach. Lastly, although the Formetric measurement of 3D posture is valid

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and reliable [25,27], it does not completely describe the actual sagittal and coronal spine
alignment. In FMS participants, using sagittal and anterior-posterior radiological profiles
would likely give further insights into exact rotation and translation displacements of
individual vertebral and overall spine curvature geometry and magnitudes.

4.2. Conclusions
The results derived from this study identified that there is a strong relationship be-
tween spinal three-dimensional (3D) misalignment as measured with the Formetric system
and the diagnosis of FMS. Our results support that the posture displacements of the thoraco-
lumbar regions can be used as part of the clinical and diagnostic indicators to determine
who has FMS and as possible outcomes of treatment interventions. Future trials should use
3D postures as an outcome measure to determine if posture rehabilitation impacts short-
and long-term outcomes in FMS sufferers.

Author Contributions: A.A. (Amal Ahbouch), I.M.M., T.S. and A.A. (Ashokan Arumugam) conceived the
research idea and participated in its design. A.A. (Amal Ahbouch), I.M.M., T.S., A.A. (Ashokan Arumugam),
P.O. and D.E.H. all contributed to the statistical analysis. A.A. (Amal Ahbouch), I.M.M., T.S. and
A.A. (Ashokan Arumugam) participated in the data collection and study supervision. I.M.M., P.O.
and D.E.H. all contributed to the interpretation of the results and wrote the drafts. All authors have
read and agreed to the published version of the manuscript.
Funding: This research received no external funding.
Institutional Review Board Statement: The study was conducted in accordance with the Declaration
of Helsinki, and approved by the Ethics Committee of the Faculty of Physical Therapy, Cairo Univer-
sity; all participants signed informed consent prior to data collection. The IRB approval number is
Cairo-PT.3-4561.
Informed Consent Statement: Not applicable.
Data Availability Statement: The datasets analysed in the current study are available from the
corresponding author on reasonable request.
Conflicts of Interest: P.A.O. is a paid consultant for CBP NonProfit, Inc. D.E.H. teaches rehabilitation
methods and distributes products for patient rehabilitation that use posture analysis similar to that
used in this manuscript. All the other authors declare that they have no competing interests.

Abbreviations

3D Three-dimensional
FMS Fibromyalgia syndrome
ICT-ITL Cervicothoracic transition point (ICT)-thoracolumbar transition point (ITL) max
ITL-ILS Thoracic-lumbar inflection point (ITL)-lumbar-sacral inflection point (ILS) max
RMS Root mean square

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 Journal of
Clinical Medicine

Article
Does Forward Head Posture Influence Somatosensory Evoked
Potentials and Somatosensory Processing in Asymptomatic
Young Adults?
Ibrahim M. Moustafa 1,2 , Aliaa Attiah Mohamed Diab 1,3 and Deed E. Harrison 4, *

1 Department of Physiotherapy, College of Health Sciences, University of Sharjah,

Sharjah 27272, United Arab Emirates
2 Neuromusculoskeletal Rehabilitation Research Group, RIMHS—Research Institute of Medical and Health
Sciences, University of Sharjah, Sharjah 27272, United Arab Emirates
3 Faculty of Physical Therapy, Cairo University, Giza 12613, Egypt
4 CBP Nonprofit (A Spine Research Foundation), Eagle, ID 83616, USA
* Correspondence: [email protected] or [email protected]

Abstract: The current investigation used somatosensory evoked potentials (SEPs) to assess differ-
ences in sensorimotor integration and somatosensory processing variables between asymptomatic
individuals with and without forward head posture (FHP). We assessed different neural regions of
the somatosensory pathway, including the amplitudes of the peripheral N9, spinal N13, brainstem
P14, peak-to-peak amplitudes of parietal N20 and P27, and frontal N30 potentials. Central conduction
time (N13–N20) was measured as the difference in peak latencies of N13 and N20. We measured
these variables in 60 participants with FHP defined as a craniovertebral angle (CVA) < 50◦ and
60 control participants matched for age, gender, and body mass index (BMI) with normal FHP
defined as CVA > 55◦ . Differences in variable measures were examined using the parametric t-test.
Pearson’s correlation was used to evaluate the relationship between the CVA and sensorimotor
integration and SEP measurements. A generalized linear model (GLM) was used to compare the SEP
measures between groups, with adjustment for educational level, marital status, BMI, and working
hours per week. There were statistically significant differences between the FHP group and control
group for all sensorimotor integration and SEP processing variables, including the amplitudes of
Citation: Moustafa, I.M.;
Diab, A.A.M.; Harrison, D.E. Does
spinal N13 (p < 0.005), brainstem P14 (p < 0.005), peak-to-peak amplitudes of parietal N20 and P27
Forward Head Posture Influence (p < 0.005), frontal N30 potentials (p < 0.005), and the conduction time N13–N20 (p = 0.004). The
Somatosensory Evoked Potentials CVA significantly correlated with all measured neurophysiological variables indicating that as FHP
and Somatosensory Processing in increased, sensorimotor integration and SEP processing became less efficient. FHP group correlations
Asymptomatic Young Adults? J. Clin. were: N9 (r = −0.44, p < 0.001); N13 (r = −0.67, p < 0.001); P14 (r = −0.58, p < 0.001); N20 (r = −0.49,
Med. 2023, 12, 3217. https://doi.org/ p = 0.001); P27 (r = −0.58, p < 0.001); N30 potentials (r = −0.64, p < 0.001); and N13–N20
10.3390/jcm12093217 (r = −0.61, p < 0.001). GLM identified that increased working hours adversely affected the SEP
Academic Editor: Hideki Murakami measures (p < 0.005), while each 1◦ increase in the CVA was associated with improved SEP ampli-
tudes and more efficient central conduction time (N13–N20; p < 0.005). Less efficient sensorimotor
Received: 23 February 2023
integration and SEP processing may be related to previous scientific reports of altered sensorimo-
Revised: 12 April 2023
tor control and athletic skill measures in populations with FHP. Future investigations should seek
Accepted: 28 April 2023
to replicate our findings in different spine disorders and symptomatic populations in an effort to
Published: 29 April 2023
understand how improving forward head posture might benefit functional outcomes of patient care.

Keywords: forward head posture; cervical spine; somatosensory evoked potential

Copyright: © 2023 by the authors.
Licensee MDPI, Basel, Switzerland.
This article is an open access article
distributed under the terms and 1. Introduction
conditions of the Creative Commons Sensorimotor integration and central somatosensory processing are brain processes
Attribution (CC BY) license (https://
that allow for the execution of certain voluntary motor behaviors in response to specific
creativecommons.org/licenses/by/
demands of the environment [1]. In other words, it is the synergistic relationship between
4.0/).

J. Clin. Med. 2023, 12, 3217. https://doi.org/10.3390/jcm12093217 https://www.mdpi.com/journal/jcm

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J. Clin. Med. 2023, 12, 3217

the sensory and motor systems [2]. Thus, the behavior pattern of healthy individuals
and movement disorder patients depends on the sensorimotor integration process [3].
Alterations in sensorimotor integration and somatosensory processing may offer insights
into differences in patient motor control abnormalities and disturbances seen in specific
spinal disorders with neurologic components [4,5].
Chronic pain is a strong contributing factor triggering sensorimotor integration
alterations [6–8]. It is known to alter specific regions of the brain functionally and struc-
turally, such as the amygdala, the anterior cingulate cortex, the medial prefrontal cortex,
and the primary somatosensory cortex. These alterations are considered maladaptive as
they result in hyper-excitability and pathway re-organization [9,10]. Theoretically, altered
afferent input is a likely explanation for the production and sustained occurrence of central
neurophysiological processing dysfunctions [11–13]. The primary motor cortex (termed
M1) is considered the central station where sensory input from the peripheral systems
converges and is processed in order to execute proper and efficient voluntary motor tasks
(sensorimotor integration). Sensorimotor integration also occurs in other regions of the
brain (the parietal cortex, the supplementary motor area, the dorsal premotor cortex, the
ventral premotor cortex, the basal ganglia, the cerebellum, and the thalamus, to name a
few). These regions are known to alter and/or contribute to voluntary motor tasks as
well. In simple terms, abnormalities of the peripheral (extremity) and central (spinal)
tissues responsible for contributing to sensory input into the sensorimotor integration
and somatosensory processing systems can cause disruption or dysfunction in the normal
afferent input and processing in the M1 region, and thus, lead to inefficient motor control
output [14,15].
There are many important questions regarding sensorimotor integration and so-
matosensory processing remaining to be addressed. For instance, the relevance of altered
alignment of the sagittal cervical spine in symptomatic and asymptomatic persons to func-
tion/dysfunction in the sensorimotor integration and somatosensory processing systems
remains understudied. It is known that the magnitude of forward head posture (FHP) is
inversely correlated to the cervical spine range of motion [16]. Furthermore, FHP alters
the length of the cervical spine through kinematic flexion/extension coupling and alters
load sharing among the discs, ligaments, and muscles of the cervical spine [17,18]. In-
vestigations on sustained cervical spine flexion have found changes in afferentation and
abnormal feed-forward control due to mechanical viscoelastic changes to the cervical spine
soft tissues that affect position sense repeatability [19]. Furthermore, straightening of the
cervical spine lordotic curvature (as often occurs with FHP) has been found to significantly
reduce the F-wave in the median nerve of the upper limbs of tested individuals, indicating
a reduction in motor–Neuronal excitability [20]. Relatively few studies have addressed
the relationship between FHP and inefficient sensorimotor integration and somatosensory
processing [21,22].
Therefore, the purpose of the current investigation is to compare the sensorimotor
integration and somatosensory processing at different neural regions of the somatosensory
system, including central conduction time, in persons with and without forward head
posture (FHP) and without overt symptomatology. The specific research questions to be
addressed herein include: (1) Using somatosensory evoked potentials, is there a difference
in sensorimotor integration and processing in asymptomatic participants without FHP
compared to participants with FHP?; (2) Do persons with FHP have abnormal sensori-
motor integration and at what region(s) does this occur?; (3) Is the possible alteration to
somatosensory processing linearly related to the amount of FHP displacement?

2. Materials and Methods

Participants were collected as a convenience sample of asymptomatic individuals.
Recruitment was obtained using both printed advertisements and social media. These
advertisements were directed only to university-related communities, such as employees,
alums, and students. All the participants were asymptomatic and had not received any

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physical therapy or any type of manual therapy treatment in the last year between Novem-
ber 2021 and July 2022. Ethics approval was obtained from our University (College of
Health Sciences, University of Sharjah, UAE) (Ethical approval number: REC-21-03-11-03-
S), and informed consent was provided to and obtained from all participants prior to data
collection, in accordance with relevant guidelines and regulations.

2.1. Participants
Sixty participants with definite forward head posture (FHP) and sixty matched control
participants without FHP were recruited for this study. Participants were matched for
age, sex, demographics, and body mass index (BMI). In order for a participant to be
categorized as having FHP, the craniovertebral angle (CVA) measurement was used, and
published cutoff values were followed. Utilizing the data published by Yip et al. [23], FHP
was classified as having a CVA < 50◦ ; thus, participants were in the FHP group when
CVA was <50◦ . Conversely, the control group was defined as having normal or no FHP
when a participant’s CVA was >55◦ . All FHP screening procedures were carried out by a
physiotherapist with 15 years of clinical experience.
As standard practice, clinicians with 10 years of experience assessed all participants.
Exclusion criteria for the current investigation were as follows: (i) any inflammatory joint
disease; (ii) any systemic pathology; (iii) a history of significant injury or primary musculo-
skeletal surgical interventions; (iv) deformity of the spine or extremities; and (v) any pain
in the past 3-months involving the musculo-skeletal system. All participants were required
to be pain-free. This was done in order to assess the potential effects of abnormal head
posture without the presence of acute pain, as the presence of pain alone is known to induce
a significant reduction in the post-central N20–P25 complex and a significant increase in
the N18 wave [24].

2.2. Measurement Techniques

2.2.1. Craniovertebral Angle (CVA)
The CVA is reliable and valid for the assessment of FHP [25]. The CVA is measured
as the angle of intersection between a horizontal line and a line bisecting the tragus of
the ear and the C7 spinous process. We followed a previously published protocol for the
measurement of the CVA in a neutral, relaxed sitting position [26]. Lateral photographs of
each participant were taken with the instructions for them to be seated in a comfortable,
relaxed, and neutral position. A tripod, with a mounted digital camera positioned 0.8 m
from the sitting participant, was placed perpendicular to the sagittal plane of the participant.
The height of the camera was set at the height of each person’s seventh cervical vertebra.
To identify the tragus of the ear and the 7th cervical spinous process, adhesive markers
were fixed on these two landmarks, which then allowed the measurement of the CVA
on the photographs. Figure 1 depicts the CVA measurement used with a representative
participant with (a) normal head posture and (b) considerable forward head posture (FHP).

2.2.2. Evaluation of Sensorimotor Integration and Somatosensory Processing

Sensorimotor integration and somatosensory processing were assessed using the neu-
rophysiological measured variables, including amplitudes of the following potentials: the
peripheral N9; spinal N13; brainstem P14; parietal N20 and P27; and frontal N30. Differ-
ences in peak latencies between N13 and N20 were measured as the central conduction
time (N13–N20). In order to assess the neurophysiological variables in this study, we used
an electromyogram device (Neuropack S1 MEB-9400K, Nihon Koden, Japan). We followed
the protocol previously reported in our earlier investigation and repeated key components
herein for clarity of understanding [21]. The skin was cleaned, and the stimulating elec-
trodes were placed on the skin overlying the median nerve 2–3 cm superiorly relative to
the distal crease of the wrist. We used a bearable, painless stimulus intensity set at 3 times
above the sensory level. No participant reported this as noxious or pain-causing [21].

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Figure 1. An example of the cranio-vertebral angle (CVA) measurement used with a representative
participant with (a) normal head posture and (b) considerable forward head posture (FHP).

For recording, all somatosensory evoked potential (SEP) recording electrodes (7 mm

Ag-AgCl disposable adhesive electrodes from Neurosoft) were placed according to the
International Federation of Clinical Neurophysiologists’ (IFCN) recommendations [21,27].
Careful attention was paid to cleaning and scarifying the skin before the attachment of the
recording electrodes on the scalp. Using an impedance below 5 kΩ, recording electrodes
were placed over the ipsilateral Erb’s point, superficial to the sixth cervical vertebra spinous
process (Cv6). Additional recording electrodes were placed at the frontal and parietal scalp
regions contralateral to the side of stimulation at 2 cm posterior to the contralateral central
and frontal scalp cites C3/4 and F3/4, which are referred to as Cc , and Fc , respectively.
Frontal and partial recording electrodes were referenced to the ipsilateral earlobe [27]. The
C6 spinous electrode was referenced to the anterior neck (tracheal cartilage). The Erb’s point
electrode was also referenced to the contralateral shoulder, as SEP components originating
from subcortical regions are best recorded with a non-cephalic reference [21,28]. A ground
electrode was attached to the forehead FPz. Figure 2 demonstrates this procedural setup.

Figure 2. An illustrative example of sensorimotor integration and somatosensory processing measurement.

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J. Clin. Med. 2023, 12, 3217

Our study protocol utilized previously published protocols [29–31]. The band was set
between 5 and 1500 Hz, with a time of 100 ms and a bandwidth of 103 μs. Using an electrical
square pulse stimulus with a duration of 0.2 ms, a total of 800 sweeps were performed and
averaged. We repeated each test a minimum of two times, where the summated tracings
were quantified for the amplitude and latency of the potentials [29–31]. The amplitude
of the individual SEP components was measured from their peak to the preceding or
succeeding trough according to the IFCN guidelines [27]. The following potentials were
assessed and recorded:
1. The peripheral N9;
2. The spinal N13 potential to the succeeding positive trough [21,31];
3. The far-field P14–N18 complex [21];
4. The parietal N20 (P14–N20 and N20–P27 complexes) [32];
5. The frontal N30 (P22–N30 complex) [21,33]. The N30 potential reflects the functional
connectivity of sensorimotor integration, which includes the thalamus, premotor area,
basal ganglia, and primary motor cortex [33–36].
The amplitude of each respective peak represents the degree of activity of its neural
structure. Alterations are believed to reflect alterations in the amount of activity of the
same assumed neural structures [27]. Peak-to-peak amplitude potentials were measured.
We used two different rates to process the different potentials: (1) the slower rate of 2.47 Hz
was optimum for N30, while (2) a faster rate of 4.98 Hz was used to quantify the potentials
for N13, P14, N20, and P27.
To assess central conduction time (N13–N20), median nerve stimulation at the wrist
of each participant was performed and determined [37,38]. Differences in peak latencies
between N13 and N20 waves function as a measure of the conduction time along the central
and spinal somatosensory pathways. All neurophysiological measures were carried out
by a physiotherapist with 20 years of experience in such measurement techniques. All
measurements were conducted at the EMG research laboratory, University of Sharjah, UAE.

2.3. Sample Size Determination

We used data from our previous study [21] to estimate the sample size needed to
identify differences in somatosensory integration measures between participants with
and without FHP. The mean differences and standard deviation of the N30 potential were
estimated to be 0.5 and 0.6, respectively, from this study. Accordingly, at least 60 participants
per group, given a significance level of 5% and a statistical power of 80%, were needed in
the current study [21].

2.4. Data Analysis

The normal distribution of all descriptive baseline variables was determined using
the Kolmogorov–Smirnov test, where continuous data are noted as mean with standard
deviation (SD) in the text and tables. Equality of variance was assessed with Levene’s test,
attaining a 95% confidence level, p-value < 0.05. Descriptive statistics (means ± SD unless
otherwise stated) are listed at each time point. In order to identify if group equivalence
was achieved for proper case-control analysis, a Student’s t-test for continuous variables or
Chi-squared for categorical variables test was performed for each demographic and clinical
variable [21].
The Student’s t-test was used to compare the means of continuous variables between
the two groups. A p-value of less than 0.05 was considered statistically significant. The
effect size was calculated using Cohen’s d where d ≈ 0.2 indicates negligible clinical impor-
tance, d ≈ 0.5 indicates moderate clinical importance, and d ≈ 0.8 indicates high clinical
importance [39]. Correlations (Pearson’s r) were used to examine the relationships between
the CVA (in the study and control groups) and the measured variables: amplitudes of the
peripheral N9; spinal N13; brainstem P14; parietal N20 and P27; frontal N30 potentials; and
the central somatosensory conduction time (N13–N20).

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A generalized linear model was used to compare the neurophysiological scores be-
tween groups, with adjustment for potential confounding variables (educational level,
marital status, BMI, and number of working hours per week). Multiple logistic regression
models were used to assess the predictors of the neurophysiological outcomes (P14, N20,
P27, N30, N13, and N13–N20). SPSS version 20.0 software was used for analyzing data
(SPSS Inc., Chicago, IL) with normality and equal variance assumptions ensured before the
analysis [21].

3. Results
Initially, 680 potential participants were screened. Neck pain and shoulder pain were
the most common reasons for participant exclusion. Sixty participants with FHP (mean age
23.5 years, SD = 2; 35 males, 25 females) and sixty age-, BMI-, and sex-matched controls
without FHP were recruited. Figure 3 shows the participant flow chart.

Figure 3. Participants’ inclusion and exclusion flow chart.

3.1. Demographic Characteristics of the Participants

Descriptive data for baseline participant demographics are presented in Table 1. No
statistically significant differences between the control and the FHP groups were found
at baseline in any of their demographic variables; p > 0.05. The mean and distribution of
craniovertebral angle for both groups are shown in Figure 4.

Table 1. Descriptive data for demographic variables. No statistically significant differences between
the control group (CG) and forward head posture (FHP) groups (p > 0.05) were found. The indepen-
dent t-test for continuous data and the Chi-squared test of independence for categorical data were
used. Values are presented as mean and standard deviation (SD) for age and weight.

Variable FHP (n = 60) CG (n = 60) p-Value

Age (years) 23.5 ± 2 25.9 ± 2 0.07
Weight (kg) 67.2 ± 3 69.2 ± 5 0.11

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Table 1. Cont.

Variable FHP (n = 60) CG (n = 60) p-Value

Gender (%)
Male 35 (58%) 33 (55%)
0.3
Female 25 (42%) 27 (45%)
Smoking
Light smoker 18 16
Heavy smoker 0 0 0.2
No Smoker 42 44
Educational level
Bachelor or Master 43 36
<0.005
High school or less 17 24
Marital status
Married 32 24
<0.005
Not married 28 36
BMI
Normal 45 26
<0.005
Obese 15 34
Working hours
Full-time 22 42
<0.005
Part-time 38 18

Figure 4. Box and whiskers for craniovertebral angle (CVA) between the forward head posture (FHP)
and control groups.

3.2. Between Group Analysis

Statistically significant differences between the FHP and control groups for all mea-
sured neurophysiological variables were identified, including amplitude of spinal N13
(p < 0.005), brainstem P14 (p < 0.005), parietal N20 and P27 (p < 0.005), frontal N30
(p < 0.005), and N13–N20 interpeak latency as a measure of central conduction time (CCT)
(p = 0.004). There was no significant difference between groups regarding the amplitudes
of the peripheral potential N9 (p = 0.07). The effect size (Cohen’s d) was moderate for
only one variable (N13–N20) and of high clinical significance for the remaining variables.
Table 2 and Figure 5 report these data. Figure 6 shows an example of the frontal, parietal,

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and cervical somatosensory findings for a representative participant with (a) normal head
posture and (b) considerable forward head posture (FHP).

Table 2. Differences between the forward head posture group (FHP) and control group (CG) for each
outcome measure of the DSSEPs for sensorimotor integration assessment. The amplitudes of the
following potentials are reported: peripheral potential N9; spinal N13; brainstem P14; parietal N20
and P27; and frontal N30. Differences in peak latencies between N13 and N20 were measured as
central conduction time (N13–N20). CI = confidence interval. (A) is a generalized linear model with
adjustment for potential confounding variables, including educational level, marital status, BMI, and
number of working hours per week.

Mean Difference
Neurophysiological (95% CI)/
FHP Group Control Group between the p Value p Value (A)
Outcome Measure Cohen’s d
Two Groups
N9 1.8 ± 0.2 1.7 ± 0.34 0.1 [0.07, 0.21]/0.1 =0.07 0.6
P14 1.67 ± 0.6 1.3 ± 0.63 0.37 [0.25, 0.49]/0.77 <0.005 0.02
N20 2.61 ± 0.61 2.1 ± 0.52 0.51 [0.33, 0.6]/0.9 <0.005 <0.005
P27 3.2 ± 0.7 2.7 ± 0.5 0.5 [0.41, 0.69]/0.8 <0.005 0.04
N30 2.91 ± 0.64 2.4 ± 0.58 0.51 [0.359, 0.69]/2.45 <0.005 0.003
N13 2 ± 0.5 1.6 ± 0.45 0.4 [0.11, 0.35]/0.8 <0.005 0.004
N13–N20 1.77 ± 0.46 1.5 ± 0.51 0.27 [0.07, 0.51]/0.56 =0.004 <0.005

4.5
Neurophysiological Outcome Measure
4

3.5

2.5

1.5

0.5

0
N9 P14 N20 P27 N30 N13 N13-N20

FHP group Control group

Figure 5. Neurophysiological outcomes for both groups. FHP = forward head posture and Control
group = normal head posture group as measured with the CVA. Statistically significant differences
between the FHP and control groups for all measured neurophysiological variables were identified,
including amplitudes of spinal N13 (p < 0.005), brainstem P14 (p < 0.005), parietal N20 and P27
(p < 0.005), frontal N30 (p < 0.005), and N13–N20 interpeak latency as measures of central conduction
time (CCT) (p = 0.004). There was no significant difference between both groups regarding the
amplitudes of the peripheral potential N9 (p = 0.07).

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Figure 6. Shown is an example of the frontal N30, parietal N20 and P27, and cervical spinal N13
somatosensory findings for a representative participant with normal head posture on the left side
and with considerable forward head posture (FHP) on the right side.

3.3. Correlation of Findings between Groups

For correlation findings, significant negative correlations were identified between
the amount of CVA and the measured neurophysiological variables in both groups. Spe-
cific to the FHP group the correlations were: amplitudes of the peripheral N9 (r = −0.44,
p < 0.001); spinal N13 (r = −0.67, p < 0.001); brainstem P14 (r = −0.58, p < 0.001); parietal
N20 (r = −0.49, p = 0.001); P27 (r = −0.58, p < 0.001); frontal N30 potentials (r = −0.64,
p < 0.001); and for central conduction time the correlation was N13–N20 (r = −0.61,
p < 0.001). Table 3 reports these data.

Table 3. Correlations (Pearson’s r) were used to examine the relationships between the cranial
vertebral angle (CVA) in the forward head posture (FHP) group and control group (CG) and the
following variables measured: amplitudes of peripheral potential N9; spinal N13; brainstem P14;
parietal N20 and P27; and frontal N30 potentials; and central somatosensory conduction time
(N13–N20).

CVA FHP CVA CG

Correlation
r (p-Value) r (p-Value)
−0.44 −0.5
N9
<0.001 <0.001
−0.67 −0.54
N13
<0.001 <0.001
−0.58 −0.57
P14
<0.001 <0.001
−0.49 −0.51
N20
<0.001 <0.001
−0.58 −0.6
P27
<0.001 <0.001
−0.64 −0.61
N30
<0.001 <0.001
−0.61 −0.56
N13–N20
<0.001 <0.001

3.4. Logistic Regession Modelling

Working hours and the CVA angle measures significantly affected the neurophys-
iological outcomes. Full-time work significantly increased the odds of having a higher
amplitude of the neurophysiological potentials and slower N13–N20 conduction time when

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compared with part-time work; p < 0.005. Additionally, each 1-degree increase in the CVA
measurement significantly decreased the amplitudes of all the potentials and resulted in a
faster, more efficient N13–N20 conduction time; p < 0.005. Table 4 reports these data.

Table 4. Logistic regression models showing the predictors of the neurophysiological outcomes.

P14 N20 P27 N30 N13 N13–N20

Odds ratios Odds ratios Odds ratios Odds ratios Odds ratios Odds ratios
Predictors
(p-value) (p-value) (p-value) (p-value) (p-value) (p-value)
0.4 0.23 0.13 0.16 0.2 0.2
BMI (Obesity)
0.06 0.06 0.3 0.34 0.06 0.06
Educational level 1.2 3.2 2.3 1.2 2.4 1.5
(Bachelor or Master) 0.4 0.08 0.3 0.4 0.32 0.42
Marital status 1.54 1.54 1.3 1.3 1.5 1.8
(Not married) 0.2 0.2 0.3 0.3 0.2 0.09
Weekly working hours 13.1 12.4 19.5 25.9 28 19.4
(Full-time) <0.005 <0.005 <0.005 <0.005 <0.005 <0.005
0.41 0.3 0.3 0.57 0.23 0.34
CVA
<0.005 <0.005 <0.005 <0.005 <0.005 <0.005

4. Discussion
Using somatosensory evoked potentials, we investigated possible differences in senso-
rimotor integration and somatosensory processing variables between asymptomatic young
adults with FHP and a control group with normal head posture. Our findings indicated
that forward head posture, as measured with the CVA, has an impact on sensorimotor
integration and somatosensory processing parameters. These findings confirmed our
study’s hypotheses. We believe this is the first investigation to provide clear evidence that
the amount of FHP alignment influences these specific neurophysiological measures in
asymptomatic persons. In our between-group analysis, the only non-significant finding
(small effect size) was for N9, which reflects the peripheral nerve volley at the axilla. This
finding ruled out peripheral nerve entrapment as a possible cause of any change. Using
generalized linear modeling with adjustment for confounding variables, working hours
per week and the CVA magnitude were found to affect the neurophysiological outcomes
significantly. Surprisingly, full-time work was found to increase the odds of having a higher
amplitude of the neurophysiological potentials and slower N13–N20 conduction time when
compared with part-time work, indicating an adverse effect on somatosensory processing
variables herein. In contrast, each 1-degree increase in the CVA measurement (indicating
better posture) significantly decreased the amplitudes of all the potentials and resulted in a
faster, more efficient N13–N20 conduction time.

4.1. Cortical, Subcortical, and Spinal Neural Changes

We identified sensorimotor integration differences and somatosensory processing
changes between both groups occurring in different regions of the spinal and cortical
regions. Previous investigations have identified results that are generally consistent with
our findings [34–36,40,41]. Likewise, previous research using symptomatic populations
has found that a general abnormal afferentation process is responsible for spinal, cortical,
and subcortical reorganization [29,30]. Thus, reorganization of the somatosensory system
is primarily driven by alterations to or modifications of sensory input, which, in turn, alters
sensorimotor integration and generalized somatosensory processing [11–13,42].
The idea that increased and abnormal FHP is a primary mechanism having the ability
to alter afferent input leading to disturbances in the sensorimotor and somatosensory
processing system, is not without evidence. Sagittal plane cervical biomechanics studies
have identified that tissue component (muscle, tendon, disc, bone) stress and strain are

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increased due to increasing FHP [17,18]. Further, it is known that as FHP increases, there
is an influence on altered joint position, kinematics, and dysfunction that may lead to
abnormal neurophysiologic afferent information (so-called dysafferentation). Furthermore,
studies suggest that increased FHP may result in increased physical demands, resulting
in premature and accelerated degenerative changes in the muscles, ligaments, bone, and
neural tissues [5,43,44]. Additionally, abnormal head posture is associated with both a re-
duced range of movement and an altered segmental cervical spine kinematic pattern. Thus,
non-neutral sagittal cervical spine alignment could potentially lead to altered sensorimotor
integration through an altered afferent input from abnormal cervical spine movements, a
change in the muscle-tendon length-tension relationships, and altered spine tissue load
sharing [16–22]. This would seem to explain the findings of Moustafa et al. [21], where
collegiate athletes with considerable FHP compared to a control group without FHP were
found to be less efficient in athletic skill tests in both static and dynamic situations.

4.2. Central Somatosensory Conduction Time

The finding of a faster (more efficient) central condition time in the participants with
normal head posture (control group) is likely multi-factorial in nature but may be largely
explained by two mechanical phenomena: (1) FHP likely increases longitudinal stress and
strain in the spinal cord tissues and (2) increased FHP alters and influences respiratory
function. Regarding the former, spinal cord biomechanics, it is expected that participants
without FHP or more normal posture alignment also have a more normal (deeper) cervical
lordosis [5,45]. A proper cervical lordosis and reduced FHP have been found to reduce
stress and strain on the spinal cord, brainstem, nerve roots, and cranial nerves 5–12 in
both surgical and non-surgical rehabilitation investigations [4,5,46–49]. Furthermore, more
normal FHP is linearly correlated with an increased overall cervical range of motion [16]
because it is known that neural axoplasm has thixotropic properties [50]. It seems logical,
therefore, that an increased viscosity (driven by impaired motion and increased spinal cord
or neural strain) could alter neuronal transport mechanisms.
Likewise, FHP may act to reduce respiratory functions of both inspiration and expi-
ration volume and strength, and thus, the maintenance of a more neutral sagittal head
posture is required to prevent these positional respiratory function reductions [51,52]. Fur-
thermore, since abnormal sagittal plane postures cause an increase in stress and strain on
both neural and vascular tissues in the cervical spine [46,47], and it is known that neuronal
tissues are highly oxygen-energy dependent [53], it is probable that increased neural strain
coupled with reductions in respiratory efficiency may be a mechanism subtly impacting
oxygenation to the spinal cord, nerve roots, and cerebral areas, leading to the alteration
in the sensorimotor integration disturbances identified in our study. Supporting these
assertions, there is evidence of an alteration in vertebral artery hemodynamics and cerebral
blood flow intensity on MRA due to alterations in sagittal cervical alignment [54,55].

4.3. Clinical Implications

While the observed differences in our neurophysiological data in terms of actual
numerical differences can be arbitrary and should not be construed as rigorous in isolation,
relating Cohen’s d between our two groups (as in Table 3) to other existing reports in the
literature offers context to the meaning or implications of our findings. Of interest, the
mean difference and effect sizes for central somatosensory conduction time (N13–N20),
sensorimotor integration (N30 potential), and somatosensory processing potentials (spinal
N13, brainstem P14, parietal N20 and P27) found in the current study are very similar to
the mean differences and effect sizes reported in a previous experimental study [56]. In
relation to clinical interpretation, it is thought that alterations in normal afferentation may
influence the processing of neural networks located in cortical motor areas and, in turn,
impact motor control [14,15]. In support of this concept, it has been identified that collegiate
athletes with increased FHP exhibited altered sensorimotor processing, integration, and
concomitantly. They were found to have less efficient athletic performance compared to

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athletes with normal sagittal head posture alignment [21]. Furthermore, a recent random-
ized trial demonstrated that structural rehabilitation (correction of abnormal alignment)
of the sagittal cervical spine allowed for more efficient responses in several sensorimotor
control outcome measurements (balance, oculomotor control, head repositioning error) [57].
Since it has been reported that central condition time (N13–N20) and the amplitude of
sensorimotor integration (N30) are linearly related to the amount of improvement in FHP
and cervical lordosis following an intervention [56], it seems probable that restoration of
the sagittal cervical alignment is a primary mechanism for improving the somatosensory
system and sensorimotor integration regions, yielding improved sensorimotor control and
more efficient motor control output in general. Future studies, however, are needed to
clarify this and identify precisely which, if any, specific motor control outcome variables
are dependent on and influenced by improved sagittal cervical alignment.

4.4. Limitations
By using a matched design, we attempted to adjust for potential confounding charac-
teristics, such as age, sex, BMI, smoking status, marital status, education, and weekly work
hours. However, as with any observational study, residual confounding factors, such as
the length of the participant’s neck, may exist. N13 is measured from the back of the C6
spinous process and N20 from the scalp. Thus, the latency of the N20 versus the latency
of the N13 may be influenced by the length of the neck and the size of the scalp/brain.
However, our participant groups were matched for sex and size, so it seems unlikely that
neck length would be a significant source of confounding in our populations. Further,
any differences in the length of the neck in our two matched groups are likely due to the
forward head posture effects on cervical spine kinematics, thus, strengthening our study
results [17–19]. Still, we recommend that future studies adjust the interpeak latencies to
each participant’s neck length.
Additionally, we did not control for certain lifestyle factors, such as physical activity
(exercise), and we did not assess the stress or anxiety level experienced by participants,
which can affect neural function. Our investigation focused on an asymptomatic population
of younger adults; therefore, participants of varying ages and with specific musculo-skeletal
disorders should be included in future studies. A further limitation is our method of FHP
measurement in that although the CVA is both a reliable and valid quantification method
for external FHP [23], the CVA cannot describe the shape and magnitude of the cervical
lordotic curve on spine radiographs [45]. Future investigations should use imaging (spine
radiographs, MRI, CT) to identify the role that actual vertebral alignment plays in altering
sensorimotor integration and somatosensory processing systems. Additionally, we rec-
ommend the assessment of patients before and after cervical spine surgical interventions
for spine disorders to identify if reductions in FHP to the recommended surgical cutoff
values (radiographic FHP < 40 mm) have an effect on improving central conduction time
(N13–N20) [5]. Finally, there are several other measurements that represent the sagittal
alignment of the head and neck, such as the sagittal head tilt (flexion/extension), sagittal
shoulder-C7 angle (protraction/retraction) [58], and these may influence the neurophys-
iological measures of sensorimotor integration and somatosensory processing. Future
investigations should look at more comprehensive measurements of sagittal cervical spine
posture in order to confirm, add to, or refute the findings of the current investigation.

4.5. Conclusions
Using a matched case-control design in asymptomatic young adults, we identified
that forward head posture is associated with differences in central conduction time, senso-
rimotor integration, and somatosensory processing amplitudes at different neural regions.
Full-time work increased the odds of having a higher amplitude of neurophysiological
potentials and slower N13–N20 conduction time. Additionally, increases in the CVA (less
forward head posture) were found to decrease the amplitudes of somatosensory processing
potentials and resulted in a faster N13–N20 conduction time.

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Author Contributions: I.M.M., A.A.M.D. and D.E.H. conceived the research idea and participated in
its design. I.M.M., A.A.M.D. and D.E.H. contributed to the statistical analysis. I.M.M. and A.A.M.D.
participated in data collection and study supervision. I.M.M., A.A.M.D. and D.E.H. contributed to the
interpretation of the results and wrote the drafts. All authors have read and agreed to the published
version of the manuscript.
Funding: CBP Nonprofit (Eagle, ID, USA) approved the funding of this manuscript for publication
fees in the JCM. Deed Harrison’s role as a senior author and conflicts of interest are outlined below.
Institutional Review Board Statement: The research was conducted in accordance with the senior
citizen’s services department and approved by the Research Institute of Medical & Health Sciences of
the University of Sharjah (reference number: REC-21-03-11-03-S).
Informed Consent Statement: All participant’s pictures in the study were included after written
informed consent was signed and obtained.
Data Availability Statement: The datasets analyzed in the current study are available from the
corresponding author upon reasonable request.
Conflicts of Interest: DEH teaches rehabilitation methods and is the CEO of a company that dis-
tributes products to physicians in the U.S.A. used for the rehabilitation of postural abnormalities. All
the other authors declare that they have no competing interests.

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Clinical Medicine

Article
Alterations in Cervical Nerve Root Function during Different
Sitting Positions in Adults with and without Forward Head
Posture: A Cross-Sectional Study
Maryam Kamel 1 , Ibrahim M. Moustafa 1,2 , Meeyoung Kim 1 , Paul A. Oakley 3,4,5 and Deed E. Harrison 3, *

1 Department of Physiotherapy, College of Health Sciences, University of Sharjah,

Sharjah 27272, United Arab Emirates
2 Neuromusculoskeletal Rehabilitation Research Group, Research Institute of Medical and Health Sciences,
University of Sharjah, Sharjah 27272, United Arab Emirates
3 CBP Nonprofit (A Spine Research Foundation), Eagle, ID 83616, USA
4 Independent Researcher, Newmarket, ON L3Y 8Y8, Canada
5 Kinesiology and Health Sciences, York University, Toronto, ON M3J 1P3, Canada
* Correspondence: [email protected] or [email protected]

Abstract: The current study aimed to determine whether participants with and without forward head
posture (FHP) would respond differently in cervical nerve root function to various sitting positions.
We measured peak-to-peak dermatomal somatosensory-evoked potentials (DSSEPs) in 30 participants
with FHP and in 30 participants matched for age, sex, and body mass index (BMI) with normal head
posture (NHP), defined as having a craniovertebral angle (CVA) >55◦ . Additional inclusion criteria
for recruitment were individuals between the ages of 18 and 28 who were in good health and had
no musculoskeletal pain. All 60 participants underwent C6, C7, and C8 DSSEPs evaluation. The
measurements were taken in three positions: erect sitting, slouched sitting, and supine. We identified
statistically significant differences in the cervical nerve root function in all postures between the
NHP and FHP groups (p < 0.001), indicating that the FHP and NHP reacted differently in different
positions. No significant differences between groups for the DSSEPs were identified for the supine
position (p > 0.05), in contrast to the erect and slouched sitting positions, which showed a significant
Citation: Kamel, M.; Moustafa, I.M.;
difference in nerve root function between the NHP and FHP (p < 0.001). The NHP group results were
Kim, M.; Oakley, P.A.; Harrison, D.E.
consistent with the prior literature and had the greatest DSSEP peaks when in the upright position.
Alterations in Cervical Nerve Root
However, the participants in the FHP group demonstrated the largest peak-to-peak amplitude of
Function during Different Sitting
DSSEPs while in the slouched position as opposed to an erect position. The optimal sitting posture
Positions in Adults with and without
Forward Head Posture: A
for cervical nerve root function may be dependent upon the underlying CVA of a person, however,
Cross-Sectional Study. J. Clin. Med. further research is needed to corroborate these findings.
2023, 12, 1780. https://doi.org/
10.3390/jcm12051780 Keywords: sitting; cervical spine; posture; evoked potentials; radiculopathy

Academic Editor: Nada Andelic

Received: 21 January 2023

Revised: 12 February 2023 1. Introduction
Accepted: 20 February 2023
Sustained sitting postures and the related load on the cervical spine are important
Published: 23 February 2023
contributors to the high prevalence of neck pain [1]. Prolonged hours of sitting have shown
a large incidence of pain in the head, neck, and shoulder region [2–5]. The optimum sitting
position is generally accepted to be a maintained and erect upright spinal position [6]. As
Copyright: © 2023 by the authors.
described by physiotherapists, an optimal sitting posture is the position with the least
Licensee MDPI, Basel, Switzerland.
amount of muscle activation and the most relaxed and comfortable posture for the entire
This article is an open access article
spine [7,8]. Presumptuously, any deviations away from this erect sitting posture is causative
distributed under the terms and of pain and discomfort [9].
conditions of the Creative Commons One issue regarding these mechanical ideologies, and popular clinical assumptions
Attribution (CC BY) license (https:// supporting the erect sitting posture, is that there is no evidence-based agreement on the
creativecommons.org/licenses/by/ optimal sitting posture, especially regarding the neck region [9–12]. Several studies support
4.0/).

J. Clin. Med. 2023, 12, 1780. https://doi.org/10.3390/jcm12051780 https://www.mdpi.com/journal/jcm

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J. Clin. Med. 2023, 12, 1780

the erect sitting as an optimal posture for the head and neck region as mechanically,
a more upright sitting posture reduces forward head translation and cervical flexion
positions [11,13]. Reducing forward head posture (FHP) and cervical flexion posture by
changes in sitting position modification has a direct influence on neck flexor and extensor
muscles [14,15].
An issue that is not typically addressed when assessing sitting posture is the presence
of pre-existing spinal misalignment or poor postures. FHP is a common poor posture that
is associated with a greater load transmitted to the neck [16,17], greater muscle activation
and fatigue [18], lower endurance of the deep neck extensors and flexors [19], as well
as substantial effects on the biomechanics of the nervous system by causing unfavorable
mechanical strain [20,21], which causes the blood vessels to constrict [22] and the nerve
root sleeves to unfold and become taut, predisposing individuals to altered or inefficient
neurophysiological symptoms [23,24]. Accordingly, we believe the combined effects of
sitting with a pre-existing FHP may likely exacerbate any overstraining of the spine and
soft tissues, including any neurophysiological effects.
Those with FHP have been demonstrated to exhibit abnormal sensorimotor control as
well as autonomic nervous system dysfunction as compared to persons without FHP [23].
It has also been shown that the therapeutic correction of FHP and cervical lordosis aids in
the improvement of sensorimotor control [24]. It is unknown, however, whether immediate
changes in sitting posture have the potential to create alterations in neurophysiologic
parameters and how these may differ between persons with and without pre-existing
FHP. Consequently, the current study aimed to determine whether participants with and
without FHP would respond differently in terms of dermatomal somatosensory-evoked
potentials (DSSEPs) to variations in sitting positions versus a supine posture. In terms
of neurophysiological outcomes, dermatomal somatosensory-evoked potentials (DSSEPs)
are methods for recording cerebral-evoked reactions to the stimulation of specific regions
innervated by single nerve roots, with the goal of supplying pure sensory input to the
central nervous system through individual spinal segments to provide reliable information
about segmental nerve root function [25].

2. Methods
Sixty (60) healthy participants voluntarily agreed to participate in this cross-sectional
study. These two groups were parallel matched in age, body mass index (BMI), and
sex. Ethics approval was obtained from University of Sharjah Research Ethics Commit-
tee in April 2021 REC-19-10-31-02-S. Following Ethics Committee approval, participant
recruitment was from April 2021 to August 2022. Informed consent was obtained from all
participants prior to the experiment according to relevant guidelines and regulations.
Participants in the NHP group were allocated as closely as possible to match those
in the FHP group. Their age was accepted if it was within 2 years apart, the BMI was
likewise matched if their BMI varied within 1–2 points. All participants were screened
prior to enrollment into the study. The exclusion criteria were as follows: any inflammatory
joint disease, systemic pathologies, previous history of musculoskeletal injuries or surgery,
spinal disorders, extremity pathologies, or musculoskeletal pain 3 months prior to the study.
Exclusion criteria information was obtained through each participant’s medical records.
Exclusions were further made of participants during the analysis of the peripheral nerve
folly (N9), as detailed below in the neurophysiological assessment section. Participants
with an abnormal N9 were excluded. DSSEP peaks follow a normal known structure,
and any abnormalities appear clearly. The N9 DSSEP peak represents the afferent signals
coming from the brachial plexus. Therefore, any participants with an abnormal N9 were
excluded, to remove any possibility of unrelated peripheral factors.
The study inclusion criteria for recruitment were any individual between the ages
of 18 and 28 who was in good health and had no musculoskeletal pain. The specific
allocation of participants to either the FHP or the NHP group was determined by the
photogrammetric craniovertebral angle (CVA) of each person [26]. Participants having a

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CVA below 50◦ were assigned to the FHP group while participants having a CVA greater
than 55◦ (considered as the cut-off for non-FHP) were assigned to the normal head posture
(NHP) group. The CVA measurement method is shown in Figure 1.

Figure 1. Measurement of the cranio-vertebral angle (CVA). The CVA is represented as the angle
above. It is formed by the line connecting two adhesive markers placed at the tragus of the ear and
the C7 spinous process; then, this line is assessed relative to a horizontal line drawn through the C7
marker. The angle θ represents the CVA.

2.1. Procedures
2.1.1. Evaluation of CVA
The CVA has a high inter-rater and intra-rater reliability in the assessment of FHP [27].
CVA is defined by the angle measured between the horizontal line bisecting the spinous
process of C7 and the diagonal line going from the C7 spinous process to the tragus of the
ear. As mentioned, we considered a CVA less than 50◦ to be the threshold for our FHP as
this is related to an increased FHP, and FHP is related to increased disability [27].
We followed the published protocol of Falla et al. for the CVA assessment [28]: neutral
lateral photos of every participant were taken. Each participant was instructed to sit up in
a neutral and comfortable position on a chair and look forward. The photograph was then
assessed for the CVA. A digital single-lens reflex camera was placed on a tripod 0.8 m away
from the participant. The camera was perpendicular to the sagittal plane of the individuals’
seated position at a height that corresponded with the seventh cervical vertebra of each
seated participant. Florescent adhesive markers were used to identify the tragus and the
C7 spinous process for the photos. All participants assumed and were assessed in the
following three positions for the experiment.

2.1.2. Positions
All 60 participants in their respective group underwent C6, C7 and C8 dermatomal
somatosensory-evoked potentials (DSSEPs). For each of the cervical nerves (C6, C7 and
C8), measurements were taken in three positions for each participant:
• Supine position (which acted as a reference for DSSEPs measurement);
• After assuming the erect sitting posture for 30 min;
• After assuming the slouched sitting posture for 30 min.

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Erect Sitting Position

As shown in Figure 2, the participants sat on a chair supporting their back. Their hips
and knees were positioned at a 90◦ angle, where the base of support was perpendicular to
the chair. The arms were rested on the armrest and the spine was assumed in a ‘neutral
upright position’ (i.e., neutral kyphosis and lordosis angles); therefore, achieving a slight
anterior rotation of the pelvis. Participants were instructed to look forward at a stationary
point straight ahead of them.

Figure 2. Sitting Positions. (A): Erect sitting, (B): Slouched sitting.

Slouched Sitting Position

Participants sat on the same chair with their back supported and were instructed
to relax their thoracolumbar spine to produce a hyperkyphotic angle at the thorax and
a straightened lordotic curve at the lumbar region, as shown in Figure 2. This causes a
posterior tilt of the pelvis, hyper-kyphosis of the thoracic spine, and a pronounced forward
head posture.

Supine Position
Participants were instructed to lay back on a flat plinth with the arms in an extended
anatomical position. The hip angle was at 180 degrees [29]. The head was supported by a
pillow to prevent interference or movement of the electrode placements [30].

2.2. Neurophysiological Outcome Measures

DSSEPs
Neurophysiological findings for C6, C7, and C8 were measured in this study as the
peak-to-peak amplitude of DSSEPs. An electromyography device (Neuropack S1 MEB-
9400K, Nihon Koden, Tokyo, Japan) was used for these neurophysiological assessments.
DSSEPs were stimulated with a continuous electrical pulse wave (0.5 ms) at 3 Hz, deliv-
ered by three standard surface gel electrodes (20 mm) placed over the respective cervical
dermatome; a reference electrode, a recording electrode, and a grounding electrode were
used. The stimulation intensity used was above each participant’s perception threshold. All
participants initially assumed a relaxed supine position where they were instructed to lay
quietly and with eyes closed during the procedure. After parting the hair and using alcohol
to prepare the skin, Nuprep gel and Ag–AgCl disc recording electrodes (10 mm with 60

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inch lead wires) were fixed with Elefix paste to the scalp (Nihon Kohden, Tokyo, Japan)
(Figure 3 shows the electrode placement). The grounding electrode was attached to a strap,
which was secured around the forearm. The impedance of all three electrodes was kept
below 5 kΩ for an even reading. Three recordings were done for each of the dermatomes
stimulated (C6, C7, and C8). The stimulation points were radial forearm 1 inch above the
wrist, the middle of the palm right below the middle finger, and the ulnar side of the palm,
respectively.

Figure 3. Left: Electrode placement following the 10–20 international EEG system; Right: Reference
and recording electrode placements.

2.3. Statistical Analysis

2.3.1. Sample Size
Estimates of mean and standard deviations (SD) from a pilot study of 10 individuals
who received the same program were collected to determine the required number of
participants in this study. The mean differences and SD of the peak-to-peak amplitude
of DSSEPs for different levels C6, 7, and 8 for the different sitting postures: supine, erect
and slouched, were: C6: −0.1 (SD 0.3), −0.17 (SD 01.2), −0.86 (SD 0.6); C7: −0.07 (SD
0.9), −0.6 (SD 0.9), −1.6 (SD 1.00); and C8: −0.1 (SD 0.4), −0.9 (SD 0.8), −1.6 (SD 0.9),
respectively. The sample size was calculated independently for each of the key outcomes
using a Bonferroni correction to adjust the significance level. The greatest sample size value
was then used as the trial’s final sample size. Given a statistical power of 80%, the current
investigation required at least 25 individuals in each group. To accommodate for probable
dropouts, the sample size was increased by 20%.

2.3.2. Data Analysis

Levene’s test of equality of error variances was used to determine the normality
distribution of the dataset at 95% confidence interval and p-value < 0.05. The dataset had
a 2 × 3 factorial design. Descriptive statistics (mean ± SD) were summarized for each
position and cervical nerve root. The unpaired t-test for continuous variables was used to
compare the means and determine the significance of the interaction between the nerve
roots in the different sitting positions. A two-way analysis of variance (ANOVA) was then
used to test the relationships between the head posture (NHP vs. FHP) and sitting position
(supine, slouched, and erect) on the cervical nerve roots (C6, C7, and C8). A p-value of 0.05
or less was considered a statistically significant difference in the dataset. Following that,
the Tukey honestly significant difference (HSD) post hoc tests were used. SPSS version 29.0
software was used for analyzing data (SPSS Inc., Chicago, IL, USA).

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3. Results
Ninety-five potential participants were initially screened. Thirty participants with
FHP and thirty age-, BMI-, and sex-matched controls without FHP were recruited for the
NHP group. Figure 4 shows the participant flow chart with numbers excluded and reasons
why. Descriptive data for the baseline participant demographics are presented in Table 1.
No statistically significant differences between the NHP and the FHP group were found at
baseline for their demographic variables. Table 1 shows the mean and distribution of CVA
for both groups.

Figure 4. Participant flowchart.

Table 1. Participant demographic variables listed as means and standard deviations. There were no
statistically significant differences between the NHP and FHP groups; p > 0.05 for all variables, using
the independent t-test for continuous data and chi-squared test of independence for categorical data.

Forward Head Group Normal Head Group

Characteristic Significance
(n = 30) (n = 30)
Age (years) 20.5 ± 2 20 ± 3 0.4
Weight (kg) 61.2 ± 4 62.2 ± 5 0.3
BMI 18.4 ± 1.2 18.3 ± 1.4 0.7
Smoking
Nonsmoker 15 14
Light Smoker 10 12 0.6
Heavy smoker 5 4
Sex
Male 11 11
-
Female 19 19
CVA 41.7 ± 2 66.9 ± 4.6 <0.001

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While the number of females in both groups was nearly double that of males, adding
sex as a fixed variable to our statistical models in this study did not produce any dif-
ference in the outcome findings. A two-way analysis of variance (two-way ANOVA)
identified significant head posture × sitting position effects on the outcome of peak-to-
peak amplitudes of the cervical nerve roots C6, C7 and C8. Results showed a statistically
significant interaction between the head posture and sitting position (F = 32.867) (p < 0.001),
(F = 38.926) (p < 0.001), (F = 40.348) (p < 0.001) for C6, C7 and C8, respectively. Tables 2–4
presents these data.
Table 2. Two-way analysis of variance results. FHP = forward head posture group, NHP = neu-
tral head posture group, Erect = neutral upright sitting posture, Slouched = slouched or slumped
sitting posture, Supine = lying supine analysis, C6, C7, C8 = the respective nerve roots tested,
C.I. = confidence interval.

Erect Slouched Supine

FHP 1.84 ± 0.33 2.30 ± 0.38 2.50 ± 0.37
C6
NHP 2.51 ± 0.36 1.92 ± 0.30 2.60 ± 0.42
p-value p < 0.001 p < 0.001 p = 0.09
C.I. [−0.80, −0.44] [0.27, 0.62] [−0.38, 0.03]
FHP 1.71 ± 0.23 2.24 ± 0.15 2.22 ± 0.20
C7
NHP 2.11 ± 0.38 1.60 ± 0.25 2.22 ± 0.42
p-value p = 0.001 p < 0.001 p = 0.72
C.I. [−0.50, −0.17] [0.49, 0.70] [−0.14, 0.20]
FHP 1.71 ± 0.41 2.61 ± 0.56 2.73 ± 0.55
C8
NHP 2.21 ± 0.40 1.70 ± 0.31 2.34 ± 0.46
p-value p < 0.001 p < 0.001 p = 0.01
C.I. [−0.80, −0.38] [0.66, 1.13] [0.08, 0.61]

Table 3. Two-way analysis of variance results.

Tests of Between-Subjects Effects

Type III Sum of Squares df Mean Square F Sig. Partial Eta Squared
C6 amplitude
Corrected Model 17.272 5 3.454 26.294 <0.001 0.430
Intercept 917.742 1 917.742 6985.400 <0.001 0.976
Head Posture 0.629 1 0.629 4.787 0.030 0.027
Sitting 8.007 2 4.004 30.474 <0.001 0.259
Head Posture * Sitting 8.636 2 4.318 32.867 <0.001 0.274
Error 22.860 174 0.131
C7 amplitude
Corrected Model 11.095 5 2.219 26.217 <0.001 0.430
Intercept 726.374 1 726.374 8581.961 <0.001 0.980
Head Posture 0.431 1 0.431 5.095 0.025 0.028
Sitting 4.075 2 2.037 24.070 <0.001 0.217
Head Posture * Sitting 6.589 2 3.295 38.926 <0.001 0.309
Error 14.727 174 0.085
C8 amplitude
Corrected Model 28.892 5 5.778 27.731 <0.001 0.443
Intercept 885.470 1 885.470 4249.485 <0.001 0.961
Head Posture 2.185 1 2.185 10.484 0.001 0.057
Sitting 9.892 2 4.946 23.737 <0.001 0.214
Head Posture * Sitting 16.815 2 8.407 40.348 <0.001 0.317
Error 36.257 174 0.208

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Table 4. Pairwise comparisons.

95% Confidence Interval for

(I) Sitting (J) Sitting Mean Difference (I–J) Std. Error Sig. b Difference b
Lower Bound Upper Bound
Dependent Variable: C6 Amplitude
Slouched 0.051 0.066 1 −0.109 0.211
Erect
Supine −0.420 * 0.066 <0.001 −0.580 −0.260
Dependent Variable: C7 Amplitude
Slouched −0.237 * 0.083 0.015 −0.439 −0.036
Erect
Supine −0.572 * 0.083 <0.001 −0.773 −0.370
Dependent Variable: C8 Amplitude
Slouched −0.012 0.053 1 −0.140 0.117
Erect
Supine −0.325 * 0.053 <0.001 −0.453 −0.196
* The mean difference is significant at the 0.05 level. b. Adjustment for multiple comparisons: Bonferroni.

Following the prolonged sitting position of 30 min, the between-group statistical

analysis was significantly different, showing a more favorable nerve root function in the
slouched sitting position for the FHP group compared to the NHP group, while the erect
sitting position demonstrated a significant favorability to the NHP group, as shown in
Table 2. Figures 5 and 6 show short latency DSSEPs for C6, C7 and C8 pre and post 30 min
of sitting in a participant from the NHP group.

Figure 5. Short latency somatosensory-evoked potential of a normal head posture (NHP) participant
before prolonged slouched sitting for C6, C7 and C8. The amplitudes measured between N20 and
P23 are: 2.45 μV, 2.8 μV, and 1.14 μV, respectively.

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Figure 6. Short latency somatosensory-evoked potential of normal head posture (NHP) participant
after prolonged slouched sitting for C6, C7, and C8. The amplitudes measured between N20 and P23
are: 2.81 μV, 2.81 μV, and 0.945 μV, respectively.

The scatterplots in Figures 7–9 show that for all three cervical nerve roots (C6, C7, C8),
their amplitudes increased in the slouched position for the FHP group compared to the
erect position. Contrarily, the NHP group displayed a higher amplitude in the erect position
than the slouched position. Both groups showed similarity in the nerve root functions in
the prolonged supine position.

C6 Nerve Root Amplitude

3

2.5

1.5

0.5

0
Erect Slouched Supine

FHP NHP

Figure 7. Scatterplot line of cervical nerve C6 amplitude relationship with the different sitting
positions for participants with forward head posture (FHP) and normal head posture (NHP). The
graph highlights that the FHP group has shown an increased amplitude during slouched sitting
compared to erect sitting. The supine position shows the highest nerve peak from all three positions.

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J. Clin. Med. 2023, 12, 1780

C7 Nerve Root Amplitude

2.5

1.5

0.5

0
Erect Slouched Supine

FHP NHP

Figure 8. Scatterplot line of cervical nerve C7 amplitude relationship with the different sitting
positions for participants with forward head posture (FHP) and normal head posture (NHP). The
graph highlights that the FHP group has shown an increased amplitude during slouched sitting
compared to erect sitting. The supine position shows the highest nerve peak from all three positions.

C8 Nerve Root Amplitude

3

2.5

1.5

0.5

0
Erect Slouched Supine

FHP NHP

Figure 9. Scatterplot line of cervical nerve C8 amplitude relationship with the different sitting
positions for participants with forward head posture (FHP) and normal head posture (NHP). The
graph highlights that the FHP group has shown an increased amplitude during slouched sitting
compared to erect sitting. The supine position shows the highest nerve peak from all three positions.

Simple main effects analysis showed that the head posture had a statistically signif-
icant effect on the cervical nerve root functions of C6 (p = 0.030), C7 (p = 0.025), and C8
(p < 0.001). As for the sitting posture, a statistical significance was also detected on the
cervical nerve roots C6 (p < 0.001), C7 (p = 0.025), and C8 (p < 0.001). Analysis with Levene’s
test of equality of error variances showed that the homogeneity of variances in our data
can be assumed for C6 (p = 0.235), for C7 (p = 0.02), and for C8 (p = 0.068).

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4. Discussion
As we had initially hypothesized, the cervical nerve root DSSEPs were identified to
have significant differences between each of the positions tested: erect sitting, slouched
sitting, and lying supine. Interestingly, our intergroup results (NHP vs. FHP groups)
showed a pattern contrary to popular belief. The NHP group displayed the greatest
peaks for DSSEPs while in the erect sitting position, and this is generally consistent with
the previous literature on ideal sitting posture; namely, that altered cervical posture has
damaging effects. In contrast, the individuals in the FHP group had the greatest peak-to-
peak amplitude of DSSEPs while in the slouched position as opposed to the erect position.
While the erect position is deemed the most correct and healthy position for the spine, our
results show otherwise relative to the initial posture of the participant. Thus, our findings
indicate the importance of considering the initial presenting cervical sagittal alignment
of the individual as a significant factor when determining the ideal sitting posture. To
our knowledge, this is the first research investigation that considers the cervical sagittal
alignment as a contributing factor when assessing different sitting postures. These findings
give new insights into an essential consensus of sitting that seem to suggest the uniqueness
of the individual’s alignment. In other words, what works well for one person may create
discomfort for another. Our main findings are in agreement with that of Dunk et al. who
reported that individuals may respond differently to various sitting postures and the
variables that influence sitting posture are still not fully understood [31]. Similarly, Adams
suggested that sustained postures, including the erect posture if maintained for a prolonged
period, can lead to discomfort and even injury [32].
One of the most important findings in this study was that for participants who already
had FHP, adopting the erect sitting position negatively affected their nerve root function, as
manifested by significant reductions in the peak-to-peak amplitude of the DSSEPs for the
nerve roots tested. Some authors have noted that an erect sitting posture [14,15] may lead
to increased levels of fatigue resulting from increased muscle activation compared with the
habitual sitting posture of an individual. In contrast, Nishikawa et al. [18] identified that
FHP compared to NHP was associated with a greater cervical spine muscle activity and
subjective fatigue using high density surface EMG. These seemingly contradictory findings
are challenging to explain and likely involve complex interactions between an individual’s
perception of their natural posture, specific spine geometric alignments of the sagittal plane
curvatures, muscle length tension relationships, and yet-undetermined variables.
It has been reported that FHP is associated with the weakening of isometric strength
and endurance of the deep neck flexors [33]. The endurance of the deep neck flexor muscles
directly affects the function of the cervical spine, and the strength of these muscles are
important in maintaining the posture and stability of the neck [33–35]. Along with the
shoulder girdle muscles, the deep neck flexors are crucial for the control and support of
the neck, supporting the weight of the head against gravity and stabilizing the head [36].
Accordingly, it is expected that assuming the erect posture for people with FHP will induce
more fatigue. Due to this, it is believed that FHP participants will be more comfortable if
they adopt a slouched posture while relying on passive structures of the spine (ligaments
and bone). During a slouched or slumped posture, it is proposed that this posture relies
mainly on the passive (e.g., spinal ligaments) structures to maintain a resting sitting position.
This results in a diminished requirement for muscle activity [37,38].
Related research has shown that muscle fatigue occurs when erect postures (such as
upright sitting) are sustained for as little as 30 min, even if contractions are as low as 2%
to 5% of the maximum voluntary contraction [39]. This offers a possible explanation as to
why participants might prefer a slumped sitting posture—because it is perceived as less
physically demanding [37,38]. Still, it is necessary to note that the decline in stabilizing
potential of the paraspinal muscles, the associated compensatory antagonistic coactivation,
and the related increase in spinal load are associated with muscle fatigue. As documented
in many studies, fatigue-related changes in muscle stiffness may reduce the capacity of
the paraspinal muscles to stabilize the spine. If fatigue is not severe (as expected in our

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study), then the compensatory recruitment of antagonistic co-contraction may restore

stability, but this will contribute to increased spinal load and an associated risk of overload
injury [40–42]. This aberrant spinal load caused by muscular fatigue might be a possible
explanation for the decrease in the peak-to-peak amplitude of DSSEPs.
A final explanation for the reduced amplitude of the DSSEPs being different in the
NHP vs. FHP groups during different sitting positions could be the amount and distribution
of the cervical lordotic curve in the participants. It is known that abnormal cervical sagittal
alignment (kyphosis, s-curves, etc.) creates changes in loading on the vertebrae and soft
tissues [43]. Gong et al. [33] reported that reduced and kyphotic cervical curves coupled
with FHP reduced the endurance of the deep neck flexors. Since it is known that increased
FHP causes flexion of the lower cervical spine and extension of the upper cervical spine [44],
it could be that slumped sitting in already FHP individuals causes a more dramatic increase
in the lower cervical spine due to the increased thoracic kyphosis that also occurs in this
posture. The increased cervical lordosis in this specific ‘exaggerated’ postural position
might reduce the net tension on the lower cervical spinal cord and nerve roots, leading to an
increased amplitude of the DSSEPs [20,45]. Though speculative, this seems like a plausible
explanation that needs to be confirmed in future investigations using spine imaging.

Study Limitations and Suggestions for Future Research

The following limitations should be considered when interpreting the current study’s
findings. We only examined the lower cervical spine nerve roots C5, C6 and C7, with-
out looking at other cervical levels. Additionally, participants in this study were young
adults, and as result, the findings might not be applicable to other age groups. Given the
limitations of the current study, future research is needed to analyze the other cervical
nerve roots, to shed more light on the upper cervical region related to different sitting
postures. Investigating the effects of different sitting postures in different age groups may
also help researchers in understanding the function of age as a contributing factor. Lastly,
we did not specifically investigate the smoking status of a participant as an independent
variable herein. However, the fact that there were almost an equal number of smokers
in the two groups eliminated the possibility that smoking could have an impact on the
outcome measure as a confounding variable between our two groups, as was shown. Still,
we suggest that future research should take smoking status into consideration. Finally, our
investigation did not formally investigate the true ideal geometric sitting posture of the
thoracic and thoraco-lumbar pelvic region, nor did it investigate mechanisms for attaining
or improving altered posture positions in participants, as has been performed in previous
investigations [46,47]. Future work could incorporate the key findings herein of how the
CVA of an individual affects nerve root function in different sitting positions and how
variations in ideal sitting postures and its training or re-training are affected.

5. Conclusions
We identified statistically significant differences in the cervical nerve root function
in all postures between the NHP and FHP groups (p < 0.001), indicating that the FHP
and NHP reacted differently in different positions. For the supine reference position, we
found no significant differences between the FHP and NHP groups for the DSSEPs of
nerve roots C6–C8. In contrast, both the erect and slouched sitting positions were found to
have significant differences in nerve root amplitudes between the NHP and FHP groups.
Specifically, the NHP group was found to have the greatest peaks for nerve root DSSEPs
while in the erect sitting position and this is generally consistent with the previous literature
on ideal sitting posture; namely, that altered cervical posture has damaging effects in sitting
posture. However, the participants in the FHP group demonstrated the largest peak-to-peak
amplitude of DSSEPs for nerve roots C6–C8 while in the slouched position as opposed to
an erect position. The ideal sitting posture and its influence on cervical nerve root function
may be dependent upon the underlying initial forward head posture presentation of a

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person, however, further research is needed to corroborate these findings in patients with
and without cervical spine disorders.

Author Contributions: M.K. (Maryam Kamel), I.M.M. and M.K. (Meeyoung Kim) conceived the re-
search idea. M.K. (Maryam Kamel), I.M.M., M.K. (Meeyoung Kim), P.A.O. and D.E.H. all contributed
to the statistical analysis. M.K. (Maryam Kamel), I.M.M. and M.K. (Meeyoung Kim) participated in
the data collection and study supervision. M.K. (Maryam Kamel), I.M.M., M.K. (Meeyoung Kim),
P.A.O. and D.E.H. all contributed to the interpretation of the results and wrote the drafts. All authors
have read and agreed to the published version of the manuscript.
Funding: Funding for the publication fee was provided by CBP Nonprofit, Inc. Deed E. Harrison
is President of CBP Nonprofit and is a member of a 13 member board that approves funding of
clinical trials. Deed Harrison’s role as a senior author and conflicts of interest are outlined above lines
489–497.
Institutional Review Board Statement: The research was conducted in accordance with ethics
committee of the College of Health Sciences, University of Sharjah and approved by the Research
Institute of Medical and Health Sciences of the University of Sharjah (reference number: REC-19-10-
31-02-S.). Consent forms were signed by participants prior to data collection and we also followed
the CONSORT guidelines.
Informed Consent Statement: All participant’s pictured in the study were after written informed
consent was signed and obtained.
Data Availability Statement: The datasets analyzed in the current study are available from the
corresponding author on reasonable request.
Conflicts of Interest: P.A.O. is a paid consultant for CBP NonProfit, Inc. D.E.H. teaches continuing
education conferences to health care providers, is the CEO of Chiropractic BioPhysics, teaches
rehabilitation methods, and sells products for patient rehabilitation to physicians in the USA. All the
other authors declare that they have no competing interests.

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Clinical Medicine

Article
A Comparison of Two Forward Head Posture Corrective
Approaches in Elderly with Chronic Non-Specific Neck Pain:
A Randomized Controlled Study
Aisha Salim Al Suwaidi 1 , Ibrahim M. Moustafa 1,2 , Meeyoung Kim 1 , Paul A. Oakley 3,4,5 and Deed E. Harrison 3, *

1 Department of Physiotherapy, College of Health Sciences, University of Sharjah, Sharjah 27272,

United Arab Emirates
2 Neuromusculoskeletal Rehabilitation Research Group, Research Institute of Medical and Health Sciences,
University of Sharjah, Sharjah 27272, United Arab Emirates
3 CBP Nonprofit (A Spine Research Foundation), Eagle, ID 83616, USA
4 Private Practice, Newmarket, ON L3Y 8Y8, Canada
5 Kinesiology and Health Sciences, York University, Toronto, ON M3J 1P3, Canada
* Correspondence: [email protected]

Abstract: Forward head posture (FHP) is a common postural displacement that is significantly
associated with neck pain, with higher risks of having neck pain in female and older populations.
This study investigated the effect of two different forward head posture (FHP) interventions in elderly
participants with poor posture and non-specific neck pain. Sixty-six elderly participants with a
craniovertebral angle (CVA) < 50◦ were randomized into either a Chiropractic Biophyics® (CBP® ) or
a standardized exercise based FHP correction group (Standard Group). Both groups were treated for
18 sessions over a 6-week period. A 3-month post-treatment follow-up was also assessed with no
further interventions. The CBP group received a mirror image® exercise and a Denneroll™ cervical
traction orthotic (DCTO); the standard group performed a protocol of commonly used stretching and
strengthening exercises for the neck. Both groups received 30 min of their respective interventions
per session. The primary outcome was the CVA, with secondary outcomes including pain intensity,
Citation: Suwaidi, A.S.A.; Moustafa, Berg balance score (BBS), head repositioning accuracy (HRA), and cervical range of motion (CROM).
I.M.; Kim, M.; Oakley, P.A.; Harrison,
After 18 sessions (6 weeks later), the CBP group had statistically significant improvement in the
D.E. A Comparison of Two Forward
CVA (p < 0.001), whereas the standard group did not. In contrast, both groups showed improved
Head Posture Corrective Approaches
functional measurements on the BBS and HRA as well as improved pain intensity. However, at
in Elderly with Chronic Non-Specific
the 3-month follow-up (with no further treatment), there were statistically significant differences
Neck Pain: A Randomized
Controlled Study. J. Clin. Med. 2023,
favoring the CBP group for all outcomes (p < 0.001). The differences in the between group outcomes
12, 542. https://doi.org/10.3390/ at the 3-month follow-up indicated that the improved outcomes were maintained in the CBP group,
jcm12020542 while the standard group experienced regression of the initially improved outcomes at 6 weeks. It
is suggested that the improvement in the postural CVA (in the CBP group but not in the standard
Academic Editor: Hideaki
group) is the driver of superior and maintained pain and functional outcomes.
Nakajima

Received: 16 November 2022 Keywords: neck pain; craniovertebral angle; forward head posture; exercise; orthotic
Revised: 18 December 2022
Accepted: 7 January 2023
Published: 9 January 2023

1. Introduction
Forward head posture (FHP) has been shown to be a common postural displacement,
Copyright: © 2023 by the authors.
with a conservative estimate of 66% of the patient population [1–3]. Studies have found
Licensee MDPI, Basel, Switzerland. that there is a significant association between neck pain and forward head posture, with
This article is an open access article higher risks of having neck pain in female and older populations [4]. It is generally believed
distributed under the terms and that this abnormal posture is associated with the development and persistence of many
conditions of the Creative Commons types of spine pain and various biomechanically driven disorders [5–7]. For example,
Attribution (CC BY) license (https:// researchers have identified that FHP posture alters cervical range of motion (ROM) [5],
creativecommons.org/licenses/by/ contributes to abnormal balance [6], and alters respiratory efficiency [7]. Many studies
4.0/).

J. Clin. Med. 2023, 12, 542. https://doi.org/10.3390/jcm12020542 https://www.mdpi.com/journal/jcm

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J. Clin. Med. 2023, 12, 542

indicate that biomechanical dysfunction of the spinal column, as seen with altered sagittal
plane alignment, results in the degeneration of the muscles, ligaments, bony structures,
and neural elements [8,9].
Therefore, there is an increased interest regarding the understanding and rehabilitation
of the sagittal configuration of the cervical spine as a clinical outcome and goal of patient
care. Despite the high prevalence of this condition, the available treatment approaches that
are directed toward FHP correction are highly variable. The methods vary, from muscle
therapy, cervical traction devices, adjustments and/or manipulations of the spinal vertebra,
postural re-education, ergonomic modifications, to corrective pillows [5,10–12]. Of interest,
while the relationship between FHP and health outcomes has been extensively studied,
the literature does not provide specific evidence on whether different methods of FHP
correction affect health outcomes differently.
In this regard, Chiropractic BioPhysics® (CBP® ) rehabilitation and traditional exercise
programs are two of the most well-known corrective techniques, while having different
mechanisms to restore proper cervical alignment [11–14]. The CBP technique is a posture-
correcting method that depends on stretching the viscous and plastic elements of the
longitudinal ligament and intervertebral discs, in addition to effectively stretching the soft
tissue through the entire neck area in the direction of normal head and neck postures [11,13].
The technique utilizes both mirror image® adjusting/manipulation, exercises, and the
unique extension traction procedures [11–13]. Meanwhile, the mirror image refers to the
reversal of the spine and posture in the opposite direction of the present malalignment
during the performance of rehabilitative procedures; the unique extension traction methods
are for restoring normal lordosis and reducing forward head posture [11,14–17].
A recent systematic review located nine controlled trials featuring Chiropractic Bio-
Physics (CBP) methods used in the rehabilitation of cervical lordosis (i.e., some form of
cervical extension traction) [14]. It was determined that there were “several high-quality
controlled clinical trials substantiating that increasing cervical lordosis by extension trac-
tion as part of a spinal rehabilitation program reduces pain and disability and improves
functional measures and that these improvements are maintained long-term” [14]. Since
this review (Oct., 2021), additional trials have emerged, further supporting the clinical im-
portance of increasing the cervical curve and reducing forward head posture using the CBP
cervical extension traction methods, but none of these trials have specifically investigated
an elderly population [15,16].
On the other hand, exercise programs that aim to correct the FHP misalignment to-
wards an ideal posture using a combination of strengthening and stretching exercises are
commonplace for physical interventions provided to correct FHP. Several studies have
shown that corrective exercise regimes can improve FHP and potentially related symp-
toms [10,17–25]. For example, exercise training protocols have resulted in improvements
in the craniovertebral angle (CVA) [8,18,24,25], head tilt [17], cranial or cervical range
of motion [24], neck disability [24], and pain [8,24]. A systematic review with pooled
meta-analysis is necessary to clarify the strength of the effect of such exercises on FHP.
Despite both techniques (CBP vs. conventional physical exercise programs) being frequently
used, to our knowledge, no research has been conducted comparing the two FHP rehabili-
tative techniques in terms of the magnitude of improved head posture and the impact of
these different techniques on balance, cervical ROM, cervicocephalic kinesthetic sensibility,
and pain. Furthermore, the majority of previous studies that explored the effectiveness
of various posture correction procedures were conducted on young individuals [20,23,24]
and these results might not be applicable to all age groups, particularly the elderly, due
to age-related musculoskeletal and physiological changes [26]. Thus, there remains a gap
in the body of knowledge on the effectiveness of the two approaches for treating elderly
patients.
Therefore, the goal of this study was to ascertain if two different FHP correction
techniques may have different effects on the CVA, balance, cervical range of motion, cer-
vicocephalic kinesthetic sensitivity, and pain in a senior population. The study hypothesis

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is that the two FHP correction procedures will have different effects on CVA and other
management outcomes such as balance, cervical ROM, cervical kinesthetic sensitivity, and
pain in the short and intermediate terms.

2. Materials and Methods

A prospective, investigator-blinded, parallel-group, randomized clinical trial was
conducted at a senior citizen service center in Sharjah, UAE. Recruitment began after
approval was obtained from our University Research Ethics Committee (reference number:
REC-18-02-27-02-S). A consent form was signed by participants before data collection. The
study was registered at ClinicalTrials.gov with registration number: NCT05533853. The
study’s starting and ending dates were 10 July 2022, through 1 November 2022, respectively.

2.1. Participants
We recruited a sample of 66 elders (>60 years) who reported chronic, non-specific neck
discomfort that had persisted for more than three months and was worse than a 3/10 on
the visual analogue scale (VAS). Chronic non-specific neck pain was defined as neck pain
provoked by neck postures, movements, or pressure for at least 3 months without a known
pathology (neurological, trauma-induced, etc.) as the cause of the complaints. Patients were
recruited from an outpatient facility at the senior citizen service center, Sharjah. Participants
were screened prior to inclusion by measuring their CVA using a photographic method by
a physiotherapist. After being screened, all potential participants were invited to undergo
a comprehensive assessment by an orthopedist, where any known pathology (neurological,
trauma-induced, etc.) as the cause of the complaints was excluded. Participants were
included if their CVA was less than 50 degrees [8,27]. Exclusion criteria included neck pain
associated with inflammatory, hormonal, and neurological disorders, neck pain related to
previous surgery, positive radicular signs consistent with nerve root compression, severe
referred pain, severe psychological disorders, and a history of spinal column fracture, spinal
tumors and related malignancies, congenital spinal anomalies, or rheumatoid arthritis.

2.2. Randomization
The patients were randomly assigned to the CBP group (n = 33) or the standardized
exercise-based FHP correction group (standard group) (n = 33) by an independent person
who selected numbers from sealed envelopes containing numbers chosen by a random
number generator. The randomization was restricted to permuted blocks of different sizes
to ensure that equal numbers were allocated to each group. Each random permuted block
was transferred to a sequence of consecutively numbered, sealed, opaque envelopes that
were stored in a locked drawer until required. As each participant formally entered the
trial, the researcher opened the next envelope in sequence in the presence of the patient.
Participants in the CBP group completed a 6-week-long, 3x per week, total of 18 sessions of
the CBP technique, consisting of Denneroll cervical extension traction and mirror image
exercises. Participants in the standard group completed a 6-week long, 3x per week, total of
18 sessions of a standardized protocol of stretching and strengthening exercises according
to the randomized trial protocol of Harman et al. [1].

2.3. Interventions
Denneroll™ Cervical Traction Orthotic (DCTO)
The CBP group received DCTO (Denneroll Industries (www.denneroll.com, accessed
on 1 October 2022) of Sydney, Australia). The patient lies flat on their back (supine) on
the ground with their legs extended and arms by their sides. The patient is encouraged
to relax while lying on the Denneroll [15,16]. The denneroll was placed on the ground
and positioned in the posterior aspect of the neck depending on the area to be addressed,
as shown in Figure 1. Participants were screened and tested for tolerance to the slightly
extended and posterior head translation position on the device to ensure they were capable
of performing this position; while the Denneroll takes the segments of the cervical spine

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near the apex of the curve to their end range of extension motion, it does not create hyper-
extension of the skull relative to the torso. The apex of the DCTO was placed in one of
three regions based on lateral cervical radiographic displacements of the cervical curve and
forward head posture:
(1) In the upper cervical area (C2-C4). This position allows for upper cervical segment
extension bending while providing minor anterior head translation (AHT). This
placement site was assigned to two participants.
(2) In the mid-cervical area (C4-C6). This position allows for mid-upper cervical exten-
sion bending while causing a significant posterior head translation. This placement
location was assigned to 8 participants.
(3) Upper thoracic/lower cervical (C6-T1) area. This position allows for lower to interme-
diate cervical segment extension bending while causing substantial posterior head
translation. This placement location was assigned to 23 participants.

Figure 1. Cervical Denneroll™ traction.

All participants began with 3-min sessions of the DCTO application and were encour-
aged to extend the duration by 2–3 min each visit until they reached the goal of 15–20 min
each session. Mirror image® traction allows for viscoelastic plastic deformation of spinal
ligaments as well as correcting the patient’s incorrect posture by initiating muscle and
ligament creep, resulting in long-term restorative improvement [11].

2.4. Mirror Image Exercises

The patient performed a sequence of mirror image exercises in the sagittal plane to
add to the correction of FHP and the cervical curvature. This sequence of maneuvers was
first proposed by Fedorchuk [28,29] and included the following steps using a right-handed
cartesian coordinate system describing rotations and translations of the head in three
dimensions [12]:
(1) Maximum anterior head translation (+TzH) Anterior head translation generates a
cervical spine coupling pattern that results in lordosis of the upper cervical spine and
kyphosis (curve reversal) of the lower cervical spine.
(2) While maintaining +TzH, maximum head extension (−RxH). Maintaining anterior
head translation permits the upper cervical spine to keep its lordosis, while maximal
head extension allows the lower cervical spine to progress toward a healthy lordotic
curvature.

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(3) While maintaining the −RxH, a posterior head translation (−TzH) with a slight
inferior compression down the long axis of the spine (−TyH) is initiated. The posterior
head translation with compression from this position allows for the head to return to
a normal postural position while maintaining the induced cervical lordosis from the
previous movements.
The patient held the final position for 10 s before relaxing and repeating it for 20 rep-
etitions. Mirror Image® exercises strengthen weak musculature and lengthen tight mus-
culatures that have adapted to unhealthy posture to correct and maintain corrections in
spinal alignment and postural abnormalities [11–13]. Figure 2 depicts a simple bike chain
analogy of this sequence of movements and its proposed effect on the sagittal cervical
spine alignment. Figure 3 depicts a patient’s lateral cervical x-rays showing the change in
alignment from neutral with this sequence of movements. A motion x-ray video analysis
of a patient performing this procedure is shown in the Supplemental Video attachment.

Figure 2. A simple bike chain analogy of the sequence of movements for the CBP group’s mirror image
exercise and its proposed effect on the sagittal cervical spine alignment. (A) depicts neutral alignment
with an altered curve; (B) depicts forward head posture (+TzH); (C) depicts upper neck/head
extension (-RxH); and (D) depicts the effects of posterior head translation (-TzH) with slight inferior
compression (-TyH). Images courtesy of Curtis Fedorchuk, reprinted with permission [28,29].

Video Supplement File S1. A motion x-ray of a patient’s lateral cervical spine demon-
strating the mirror image exercise in the following sequence: first, forward head posture
(+TzH); second, upper neck/head extension (−RxH); and third, posterior head translation
(−TzH) with slight inferior compression (−TyH).

2.5. The Standardized Exercise Based FHP Correction Group (Standard Group)
Patients in the standard group were given a posture correction exercise program that
included two strengthening exercises (deep cervical flexors and shoulder retractors) and
two stretching exercises (cervical extensors and pectoral muscles). The exercise program
was conducted according to Harman et al.’s [1] protocol and based on Kendall et al. [2]
approach. The rationale for using the exercise protocol and exercise types herein is that
it is a known standardized protocol used in randomized trials and clinical settings for
the treatment and improvement of FHP in patient populations [1,2,20]. Further, this FHP
exercise protocol is the accepted protocol in the senior citizen care center in Sharjah, UAE,
where our trial was conducted. The protocol involved the following:

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Figure 3. A patient’s lateral cervical x-rays are shown in neutral and after the mirror image exercise
sequence (+TzH, −RxH, −TzH, −TyH) demonstrating the change in alignment from neutral with
this sequence of movements: forward head posture (+TzH), upper neck/head extension (−RxH),
followed by posterior head translation (−TzH) with an inferior compression component (−TyH).
Images courtesy of Curtis Fedorchuk, reprinted with permission [28,29].

1. Chin tucks were performed while lying supine with the head in touch with the floor,
which progressed to lifting the head off the floor in a tucked posture and holding it
for varied periods of time (this was to progress by two-second holds starting at two
seconds, i.e., 2, 4, 6, and 8 s. During the session, patients completed five chin tuck
repetitions and five to seven sets of five chin tucks with a 1-min rest between each set.
Figure 4 presents this exercise.
2. Chin drop while sitting to stretch cervical extensors (the progression of this exercise
was to drop the chin with hand assistance). The patients were instructed to flex the
neck until a good stretch was felt at the base of the head and top of the neck. The
patient held the final position for 5 s. This chin drop exercise was repeated a total
of 10 times, or as tolerated. A modification of the chin tuck that further emphasizes
strengthening of the deep neck flexor muscles is to apply resistance with a hand
placed under the tucked chin and apply light downward pressure into the hand, or by
adding manual resistance to the forehead using the 5-s hold time approach. Figure 5
demonstrates this exercise maneuver.
3. Pulling the shoulders back using a theraband while standing to strengthen the shoul-
der retractors. The patient was instructed to squeeze their scapulae together tightly
for at least 6 s without elevating or extending their shoulder. The initial progression
step was to use weights to do shoulder retraction from a prone posture. The second
stage involved the use of elastic resistance and weights. Each progression was carried
out by the participants for two weeks. At the consultation, they were moved to the
second progression if they could complete three sets of 12 repetitions, with 2 min of
rest in between, accurately for appropriate strengthening. Figure 6 demonstrates this
exercise maneuver.
4. Every two weeks, participants alternated between unilateral and bilateral pectoralis
stretches. The patient was seated comfortably with their hand behind their head for
bilateral pectoralis stretching. From this posture, the patient’s elbow was pushed up
and out to the limit of its possible range. The arm at the affected location was shifted

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into abduction and external rotation for unilateral stretching. The end position was
maintained for 20–30 s and repeated 3–5 times. For unilateral stretching, the patients
were directed to bring their hands up such that their forearms and elbows rested on
the side of the doorway. The elbow and shoulder should be at a 90-degree angle. The
patient was encouraged to move his or her body toward the opposite side away from
the doorway until a stretch was felt anteriorly between the chest and shoulder. Each
stretch was performed with slow, steady movements without any bouncing. The same
process was repeated on the opposite side. This posture was maintained for 20–30 s
and repeated 3–5 times. Two sets of 3–5 repetitions of unilateral self-stretching with a
1-min rest were performed for each patient. Figure 7 shows this exercise maneuver.

Figure 4. The chin tuck exercise: (A) starting position; (B) chin tucks performed while lying supine
with the posterior aspect of the skull in contact with the floor; (C) the head is then lifted off the floor
in a tucked posture.

Figure 5. The chin drop exercise: (A) the starting position; (B) the end stretching position; (C) a
modification of the chin tuck that further emphasizes strengthening of the deep neck flexor muscles.

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Figure 6. Scapular retractors strengthening exercise: (A) pulling the shoulders back using a theraband
for resistance while standing to strengthen the shoulder retractors; (B) the initial progression step
was to use weights to do shoulder retraction from a prone posture.

Figure 7. In (A) a unilateral pectoralis stretch is shown. In (B) a bilateral pectoralis stretch position is
shown.

While the CBP group seemingly received an extra intervention (the DCTO plus mirror
image exercises), the standard group received more exercise types and number of repeti-
tions. Thus, both groups were exposed to and received similar treatment durations, which
were approximately 30 min per session.

2.6. Outcome Measures

A series of outcome measures were obtained at three intervals: (1) baseline, (2) one day
following the completion of 18 visits after 6 weeks of treatment, and (3) three months after
the participants’ 18-session re-evaluation. The sequence of measurements was identical
for all participants. The primary outcome measure was the cranio-vertebral angle (CVA).
Whereas secondary outcomes included (1) neck pain, (2) Berg balance scale (BBS), (3) head

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repositioning accuracy (HRA), and (4) cervical ROM. All outcome assessments were carried
out with the same data collectors, who were blinded to group allocation to prevent potential
recorder and ascertainment bias. Participants were blinded to their measurement scores to
address potential expectation bias and were instructed not to inform the assessors of their
intervention status.

2.6.1. Craniovertebral Angle

The assessment of forward head posture (FHP) was conducted by measuring the
craniovertebral angle. If the angle was less than 50 degrees, it was considered to be FHP, as
guided by Yip et al.’s study, where the normal range is between 55 and 86 [27]. The CVA
as an assessment measurement for FHP has good reliability and excellent validity [30,31].
The measurement technique was duplicated, as in the study by Diab and Moustafa [8], as
follows: adhesive markers (8 mm in diameter) were placed on the participant’s C7 spinous
process and tragus of the ear. The physical therapist observed the participant from the
lateral side while standing and then took a picture of the participant from a fixed distance
(75 cm) and height (150 cm), then with the help of an application sealed by a password, the
angle was measured by placing each vector as following a line from the tragus of the ear
to the C7 spinous process and another horizontal line through the C7 spinous process [8].
Figure 8 demonstrates the CVA as used.

Figure 8. CVA at three intervals: (1) baseline, (2) one day following the completion of 18 visits after
6 weeks of treatment, and (3) three months after the participants’ 18-session re-evaluation.

2.6.2. Berg Balance Scale

Balance was measured by the Berg balance scale with a total score of 56; if the score
was less than 45, this predicted the risk of falling. The scale has excellent reliability and
concurrent validity [32].

2.6.3. Numeric Pain Rating Scale

The numeric pain rating scale (NPRS), where 10 is the worst pain and 0 is no pain, was
used to assess pain. It is valid and has moderate reliability in assessing cervical pain [33].

2.6.4. Cervicocephalic Kinesthetic Sensibility

Cervicocephalic kinesthetic sensibility was used to detect alterations in cervical pro-
prioception. The blindfolded subject must be able to accurately relocate the head into a

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straight-head position after being actively moved to the new maximum position, either
in the horizontal or vertical plane. The deep suboccipital muscle is the main contributor
to proprioception signaling when vision is occluded. Muscular and articular pain will
lead to functional deficits that will affect the kinesthetic findings [34]. The reliability of
cervicocephalic kinesthetic sensibility ranges from fair to excellent; however, it is accept-
able [35]. The assessment procedure was the same as Ravi et al.’s, and the cervical range of
motion instrument (CROM) was used [36]. CROM has good reliability and validity for use
in cervicocephalic kinesthetic sensibility measurement [35,36].

2.7. Sample Size Determination

Sample size estimates of mean and standard deviations were collected from pre-
vious studies that utilized a similar protocol to our study. The mean differences and
standard deviation of the CVA were estimated to be 14◦ and 12◦ , respectively, from these
studies [14,37–39]. Accordingly, 25 participants for each treatment arm, given a significance
level of 5% and statistical power of 80%, were needed in the current study. To compensate
for potential participant withdrawal, a 10% increase in sample size was implemented.

2.8. Data Analysis

The statistical procedure depended on the principle of intention-to-treat for between
group comparisons. Significance was set to P-values less than 0.05. In order to manage any
missing data, multiple imputations were used. Parametric methods for significance testing
were determined with Levene’s test for equality of variances and the Kolmogorov–Smirnov
test, expressing continuous data as means with standard deviation (SD) in text and tables.
In order to follow-up and compare the effects of the two alternative treatments, the
results were examined through a two-way analysis of covariance (ANCOVA). The model
was working as follows: a group and time were used as a single independent factor, and
group × time as an interaction factor. The level of significance used for the study was set
at α= 0.05. The Pearson correlation coefficient (r) was used to investigate the correlation
between FHP and outcome variables. To impute the missing values for both groups,
multiple regression models were constructed, including the potentially related variables
from the missing data that correlated with that outcome. SPSS version 20.0 software was
used for analyzing data (SPSS Inc., Chicago, IL, USA), with normality and equal variance
assumptions ensured prior to the analysis.

3. Results
A diagram of patients’ retention and randomization throughout the study is shown in
Figure 9. One hundred and twenty patients were initially screened. After the screening
process, 66 patients were eligible to participate in the study, and 66 (100%) completed
the first follow-up at 6 weeks, while 62 of them completed the entire study, including the
3-month follow-up. Three participants in the standard group tested positive for COVID
and were unable to make the 3-month follow-up, while one participant in the CBP group
had travel conflicts and was unable to complete the 3-month follow-up. See Figure 9.
The study design did not include a pre-determined adverse event protocol. However,
participants were formally asked during their treatment sessions if they were experiencing
any unusual adverse events or increased pain due to the interventions. No adverse events
were documented by the treating therapist aside from minimal and transient discomfort in
the neck as the patient acclimatized to using the DCTO at the point of cervical spine contact
over the apex of the device.

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The demographic characteristics of the patients are shown in Table 1.

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Table 1. Baseline participant demographics. CBP is the group receiving mirror image exercise
plus the Denneroll™ cervical traction orthotic (DCTO). The standard group is the group receiving
standardized strengthening and stretching exercises to correct FHP. Values are expressed as means ±
standard deviation (SD) where indicated.

CBP Group Standard Group

Demographic Information p Value
(n = 33) (n = 33)
Age (y) 63.5 ± 3 65 ± 4.2 0.09
Weight (kg) 66 ± 10 60 ± 19 0.1
Sex, Marital status
Male 22 (67%) 20 (60%)
Female 11 (33%) 13 (40%)
Single 1 (3%) 2 (7%) 0.3
Married 22 (67%) 20 (60%)
Separated, divorced, or widowed 10 (30%) 11 (33%)
Pain duration (%) [Mean ± SD]
<1y 1 (3%) 3 (10%)
1–2 y 21 (67%) 20 (60%) 0.1
>2 y 10 (30%) 10 (30%)
Smoking history
Light smoker 8 (24%) 7 (21%)
Heavy smoker 0 1 0.2
Non-Smoker 25 (76%) 26 (79%)

Group Outcomes
The general linear model with repeated measures identified significant group * time
effects in favor of the CBP group for the following management outcomes: CVA (F
(3.114) = 131, p < 0.001); pain intensity (F (3.114) = 54, p < 0.001); HRA right (F (3.114) = 183,
p < 0.001); HRA left (F (3.114) = 208, p < 0.001); Berg balance score (F (3.114) = 29.2, p < 0.001);
and cervical ROM, p < 0.001. However, subsequent analyses indicated that, after 6 weeks
of treatment, both treatments were similarly improved in some management outcomes. At
6 weeks, the unpaired t-test analyses found insignificant differences between groups for
the following parameters: Berg balance score (p = 0.48), HRA Right (p = 0.6), and HRA left
(p = 0.3). Tables 2–4 show these details for each variable.

Table 2. The changes in pain and CVA in both groups vs. time. CBP = CBP group; standard = standard
exercise groups; CVA= craniovertebral angle; pain intensity is 0–10 where 0 is no pain and 10 is
incapacitated; G = group; T = time; G vs. T = group vs. time; all values are expressed as means ±
standard deviation; [] = 95% confidence interval; p-Value = statistical significance; * = statistically
significant difference.

3-Month p-Value
Baseline 6-Weeks
Follow-Up G T G vs. T
CBP G 41.4 ± 2.6 54.9 ± 3.2 54 ± 2.6 <0.001 * <0.001 * <0.001 *
CVA F = 76 F = 248 F = 131
Standard G 42.7 ± 3.2 45 ± 2.4 45.6 ± 5.9 Partial Eta squared = 0.5 Partial Eta squared= 0.8 Partial Eta squared = 0.7
p-Value 0.08 <0.001 * <0.001 *
95% C.I. [−2.7, 0.2] [8.7, 11.1] [6.1, 10.7]

Pain CBP G 4.7 ± 0.8 1.1 ± 0.7 0.5 ± 0.8 <0.001 * <0.001 * <0.001 *
intensity F = 209 F = 244 F = 54
Standard G 5.3 ± 1.5 2.9 ± 1.2 4.3 ± 1 Partial Eta squared = 0.7 Partial Eta squared = 0.8 Partial Eta squared = 0.6
0.08
p-Value <0.001 * <0.001 *
[−1.19,
95% C.I. [−2.2, −1.2] [−4.2, −3.2]
0.008]

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Table 3. The changes in the Berg balance score for balance assessment and HRA in both groups vs.
time. CBP = CBP group; standard: standard exercise group; HRA = head repositioning accuracy;
G = group; T = time; G vs. T = group vs. time; all values are expressed as means ± standard deviation;
C.I. [] = 95% confidence interval; p-Value = statistical significance; * = statistically significant difference.

3-Month p-Value
Baseline 6-Weeks Follow-Up
G T G vs. T
Berg CBP G 43 ± 2.1 48.1 ± 3 48.2 ± 3.2 <0.001 * <0.001 * <0.001 *
Balance F = 28.3 F = 91.3 F = 29.2
Score Standard G 42.3± 2.2 44.6 ± 1.7 43.8 ± 2.1 Partial Eta squared =0.3 Partial Eta squared = 0.6 Partial Eta squared = 0.7
p-Value 0.2 0.48 <0.001 *
C.I. [−0.49, 1.7] [2.2, 4.7] [2.9, 5.5]

HRA CBP G 3.4 ± 0.6 2.1 ± 0.9 0.3 ± 0.5

Right <0.001 * <0.001 * <0.001 *
Standard G 3 ± 0.9 2.2 ± 1.1 2.7 ± 1 F = 43 F = 193 F = 183
p-Value 0.06 0.6 <0.001 * Partial Eta squared = 0.5 Partial Eta squared = 0.8 Partial Eta squared = 0.8
C.I. [0.023, −0.77] [−0.3, 0.2] [−2.5, −2.1]

HRA CBP G 3.8 ± 1.4 2.2 ± 1.4 .4 ± 1.1

Left <0.001* <0.001* <0.001*
Standard G 3.2 ± 0.9 2.5 ± 1.6 2.9 ± 1.2 F = 20.3 F = 184 F = 208
p-Value 0.07 0.3 <0.001 * Partial Eta squared = 0.2 Partial Eta squared = 0.8 Partial Eta squared = 0.8
C.I. [0.02, −1.1] [−0.6, 0.07] [−2.8, −2.1]

Table 4. The changes in ROM outcomes in both groups vs. time. The values are mean ± standard
deviation. CBP = CBP group; standard: standard exercise group; G = group, T= time, C.I. [] = 95%
confidence interval, p-Value = statistical significance; * = statistically significant difference.

3-Month p-Value
Baseline 6-Weeks Follow-Up
G T G vs. T
<0.001 * <0.001 * <0.001 *
F = 44.2 F = 132 F = 44.9
CROM lateral CBP G 36.9 ± 2.8 42.4 ± 2 42.1 ± 2.2
Partial Eta Partial Eta Partial Eta
flexion right squared = 0.5 squared = 0.6 squared = 0.5
Standard G 37.2 ± 2 40.6 ± 3 37.4 ± 3.8
p-Value 0.5 <0.008 * <0.001 *
C.I. [−0.9, 1.3] [0.5, 3.1] [3.6, 5.7]
<0.001 * <0.001 * <0.001 *
F = 23 F = 104 F = 40
CROM lateral CBP G 37.5 ± 2.3 42.6 ± 1.8 42.2 ± 2.6
Partial Eta Partial ETA Partial Eta
flexion left squared = 0.3 squared = 0.7 squared = 0.5
Standard G 37.1 ± 2.7 40.1 ± 2.6 37.8 ± 2.5
p-Value 0.4 <0.001 * <0.001 *
C.I. [−0.6, 1.4] [0.8, 3.1] [3.3, 5.4]
<0.001 * <0.001 * <0.001 *
F = 24 F = 150 F = 72
CROM CBP G 61.1 ± 5.3 71.40 ± 2.3 70.8 ± 4
Partial Eta Partial Eta Partial Eta
rotation right squared = 0.2 squared = 0.8 squared = 0.7
Standard G 62.3 ± 5.6 63.6 ± 4.8 62 ± 6.1
p-Value 0.1 <0.001 * <0.001 *
C.I. [−2.8, 2.5] [5.8, 9.6] [6.4, 11.2]
<0.001 *
F = 73 F = 46
F = 24.6
CROM CBP G 62.15 ± 4.5 70.7 ± 3.9 70 ± 5.7 Partial Eta Partial Eta
Partial Eta
rotation left squared = 0.7 squared = 0.6
squared = 0.3
Standard G 60.9 ± 6.4 63.4 ± 4.5 61.2 ± 6.7
p-Value 0.3 <0.001 * <0.001 *
C.I. [−1.4, 4.2] [5.2, 9.1] [6, 11.4]

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In contrast to the 6-week outcomes, the between-group analyses at the 3-month follow-
up revealed statistically significant between-group differences for all the management
variables. Tables 2–4 show these details for each variable.
Correlations (Pearson’s r) between the amount of change in CVA angle and the amount
of change in all measured outcomes at 3-month follow up compared to the initial scores are
shown in Table 5. All measured variable change scores in both groups were moderately
to strongly negatively correlated (pain intensity and HRA left and right) and positively
correlated (all other variables) to the amount of change in the CVA, indicating that as
FHP decreased, the various outcome variables were found to be improved. Specially, a
negative correlation between CVA and pain and HRA indicates that as CVA increases (FHP
decreases) pain intensity and HRA decrease. See Table 5 for details.

Table 5. Correlations (Pearson’s r) between the amount of change in CVA angle and the amount of
change of all measured outcomes (3-month follow-up scores and initial scores).

Δ CVA Δ CVA
CBP Group Standard Group
Correlation between Variables
r (p Value) r (p Value)
n = 33 n = 33
−0.7 −0.67
ΔPain intensity
(<0.001) (<0.001)
0.64 0.49
ΔBerg Balance Score
(<0.001) (<0.001)
−0.69 −0.71
Δ Head repositioning accuracy (Right)
(<0.001) (<0.001)
−0.72 −0.72
Δ Head repositioning accuracy (Left)
(<0.001) (<0.001)
0.49 0.61
Δ CROM lateral flexion Right
(<0.001) (<0.001)
0.57 0.52
Δ CROM lateral flexion Left
(<0.001) (<0.001)
0.49 0.61
Δ CROM rotation right
(<0.001) (<0.001)
0.57 0.52
Δ CROM rotation left
(<0.001) (<0.001)
CVA = craniovertebral angle; Δ = change.

4. Discussion
Unexpectedly, there was a significant difference between the groups regarding the
CVA, favoring the CBP group. However, the patient perceptive outcomes of neck pain and
the functional outcome measures (berg balance, HRA, and cervical ROM) showed fewer
differences between the groups at 6 weeks of treatment. In contrast, after 3 months of follow-
up with no further interventions, the standard exercise group’s improvements regressed
back to baseline values, while the CBP group showed sustained improved management
outcomes for all variables. Thus, these contrasting trends of changes in outcomes at
3 months after the treatment between our two groups may indicate that our hypothesis is
supported, namely, that using different FHP correction techniques will differently affect
the amount of CVA and other related outcomes.

4.1. Sagittal Cervical Alignment

The improvement in FHP and cervical lordotic curve recorded by the CBP group was
anticipated in as much as previous investigations have identified that this DCTO does
indeed improve cervical lordosis and reduce anterior head translation [37–39]. Sustained
extension loading on devices like the Denneroll causes stretching of the visco-elastic tissues

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(discs, ligaments, and muscles) of the cervical spine in the direction of the neutral head
and neck posture and increased lordosis; this is the likely explanation and rationale for
sustained extension loading restoring the cervical lordosis and improving anterior head
translation [37–41].
There was considerable improvement in the CBP group in comparison with the stan-
dard group, and our study identified a similar mean improvement in the CVA compared to
a previous investigation using the DCTO [37]. Interestingly, the similar improvement in
the CVA in the current study compared to the previous investigation seems contradictory
in as much as only 18 sessions were used herein on the Denneroll, while the previous
investigation used 30 sessions [37]. The fact that 60% of the treatments yielded similar
postural changes may be attributed to the elderly age range and decreased elastic recovery
in comparison to younger age groups. Previously, Oliver and Twomey [42] identified
that elderly cadaveric spines obtained more viscoelastic creep deformation and less elastic
recovery compared to younger aged specimens under the same extension loading scenario.
It is important to understand the role of collagen and how age-related changes to collagen
matrices are linked to the declining mechanical properties of aging bones and joints [43,44].
Physical and biochemical changes occur in collagen with increasing age, resulting in de-
creased extensibility. These changes include an increased formation of intramolecular and
intermolecular cross-links that restrict the ability of the collagen fibers to move past each
other as tissue length changes [45]. Another possible explanation for the same magnitude
of improvement in the CVA in 40% fewer treatment sessions could be the effectiveness of
the new mirror image exercise sequence as performed herein. Problematically, we did not
have a group that compared this exercise alone, so it remains unknown which intervention
created the most improvement in the CVA.
Regardless of which intervention improved the CVA more significantly in the CBP
group, we suggest it is likely that the improvement of cervical sagittal alignment is the main
modulator for the enhanced and maintained changes in the pain and functional outcome
measures in our CBP group, as supported by the strong correlation between the amount
of change in the CVA in both groups and measurement outcomes at the two intervals of
re-assessment. It is likely that the continuous asymmetrical loading from altered posture
(forward head posture) may be the possible explanation for the decline in functional status
for the control group at 3 months follow-up, as supported by predictions from experimental
and biomechanical spine-posture modeling studies [46,47], surgical outcomes [48,49], and
large cohort investigations [50]. Abnormal posture is considered a predisposing factor for
pain because it elicits abnormal stresses and strains in many structures, including bone,
intervertebral discs, facet joints, musculotendinous tissues, and neural elements [46–52].
The participants in our standard exercise group completed a 6-week-long, 3 x per week,
18-session protocol of standardized stretching and strengthening exercises according to the
randomized trial protocol of Harman et al. [1]. We followed this methodology because it
built on the known protocols from Kendall et al. [2], and it has been documented that these
types of standardized stretching and strengthening exercises are effective at reducing FHP
and improving patient cervical spine conditions in clinical trials [1,2,20]. Thus, this standard
treatment of exercises provided an established evidence-based protocol to compare and
contrast the CBP group’s treatment to. There are several other exercise systems in the
literature designed to improve FHP abnormalities (Pilates [24], McKenzie [23], biofeedback
methods [22], and Feldenkrais techniques [53]) that we could have used to compare the
CBP group outcomes to. However, we elected to use the standard exercises herein, as they
are commonly used in clinical settings, have documented results in clinical trials, and this
is the accepted protocol that is actively used in our university’s senior care center. However,
to our knowledge, none of these protocols have been uniquely investigated in an elderly
population with defined FHP and neck pain such as in our investigation, making our trial
and results unique.

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4.2. Balance, Pain, Cervicocephalic Kinesthetic Sensibility and ROM

Importantly, after restoring the proper cervical sagittal alignment, there were recorded
improvements in a wide range of main complaints that were not just related to neck pain;
balance, ROM, and repositioning accuracy were all reported to have improved. According
to the most recent research, neck pain relief following cervical spine therapy, including
better radiographic sagittal plane alignment, shows a clear causal relationship. For instance,
Harrison et al. statistically differentiate symptomatic neck pain patients from asymptomatic
volunteers based on discriminant analysis based on the cervical sagittal alignment [54].
According to McAviney et al. [55], individuals with neck curves (C2-7 posterior tangents)
less than 20◦ had a two-fold increased risk of suffering neck discomfort, and those with
curves less than 0◦ (straight and kyphotic curves) had an 18-fold increased risk. Neck pain
is also linked to a forward head posture, which can happen with lordosis loss [49].
A growing body of research suggests that the FHP and balance are directly related.
For instance, Moustafa et al. found a significant association between the CVA and the
postural stability index as a measure of balance and posture stability [56]. In terms of
ROM improvements, our findings are in line with the findings of Darnel’s research [57],
which stated that “correct mechanical alignment is crucial for cervical joint performance”.
These results are generally consistent with those of White and Panjabi [58], who claimed
that coupled motions in the cervical spine rely on a variety of variables, including the
posture of the spine, the geometry of the individual vertebrae, and the orientation of the
facet joints. Additionally, Miyazaki et al. [59] performed a retrospective study employing
kinetic magnetic resonance imaging looking at the connection between disc degeneration
and changes in the sagittal alignments of the cervical spine. According to them, when
the alignment changed from normal to a cervical lordotic curvature that was smaller,
the segmental translational motion and angular displacements tended to decrease at all
levels [59].

4.3. Limitations
As with all investigations, our study has some limitations, each of which lends itself to
a future investigation. A primary limitation was that our sample was a convenient sample
rather than a random sample of the entire aging population. Second, we did not include a
natural history group, and we did not assess the effects of different numbers of treatment
interventions to identify the optimum frequency and duration of treatment in seniors with
FHP and neck pain. Thus, it remains to be seen what effect a greater frequency and number
of traction sessions will produce and what effect the Denneroll would have on improvement
of altered posture alignment in disorders other than chronic neck pain in the elderly
population. Third, we used a combined treatment approach of Denneroll extension traction
with a new sagittal plane mirror image exercise sequence, and we were not able to discern
the effects on the CVA and outcome measures from each individual therapeutic intervention.
Additionally, despite better outcomes in the CBP group, clinically they remained at an
average CVA value that is on the cusp of normal [27]. Therefore, in practice, many of these
patients would require continued treatment to correct the CVA to below the normative
threshold. It is yet to be determined if this would translate into continued outcome
improvements. Likewise, this investigation used a relatively short duration of follow-up at
3 months; it is therefore not known how long the improvements in the CBP group would
remain. Lastly, the results of the current RCT do not indicate the superiority of the CBP
technique for postural correction in comparison to other FHP corrective methodological
systems. There are several other postural corrective techniques used in conservative care of
patients (Pilates [24], McKenzie [23], Biofeedback [22], and Feldenkrais [53] techniques for
examples), and these techniques should be looked at in future randomized trials to identify
their effects on the CVA, pain, balance, and cervical spine mobility in elderly populations
in an effort to identify the optimum course of treatment for seniors presenting with neck
pain, disability, and abnormal FHP.

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4.4. Conclusions
This study demonstrated that although both the CBP and standardized exercise-
based FHP correction groups demonstrated initial immediate (post-intervention) improved
outcomes, the CBP group that included use of the DCTO resulted in greater immediate
improved outcomes and also a maintenance of improved outcomes at the 3-month follow-
up. The standard FHP exercise group experienced regression of the improved outcomes at
the 3-month follow-up. It is suggested that the improvement in the postural CVA (in the
CBP group but not in the standard exercise group) is the driver of superior and maintained
pain and functional outcomes at final follow-up. Therefore, clinical treatments that are
known to improve forward head posture should be added to the clinical armamentarium
for the rehabilitation of properly selected seniors with chronic neck pain and forward head
posture.

Supplementary Materials: The following supporting information can be downloaded at: https:
//www.mdpi.com/article/10.3390/jcm12020542/s1, Video S1: Mirror image sagittal plane exercise.
Author Contributions: A.S.A.S., I.M.M., M.K. and A.S.A.S. conceived the research idea and par-
ticipated in its design; A.S.A.S., I.M.M., M.K., A.S.A.S., P.A.O. and D.E.H. All contributed to the
statistical analysis; A.S.A.S., I.M.M., M.K. and A.S.A.S. participated in the data collection and study
supervision; I.M.M., P.A.O. and D.E.H. All contributed to the interpretation of the results and wrote
the drafts. All authors have read and approved the final version of the manuscript and agree with
the order of presentation of the authors. All authors have read and agreed to the published version of
the manuscript.
Funding: Cervical Dennerolls for use in this trial were supplied by CBP Nonprofit, Inc. Deed E.
Harrison is President of CBP Nonprofit and is a member of a 13-member board that approves funding
of clinical trials. Deed Harrison’s role as a senior author and conflicts of interest are outlined below in
the conflicts of interest section.
Institutional Review Board Statement: The research was conducted in accordance with the Senior
Citizens Services Department and approved by the Research Institute of Medical & Health Sciences
of the University of Sharjah (reference number: REC-18-02-27-02-S). The consent form was signed
by participants prior to data collection, we also followed the CONSORT guidelines. The study was
registered at ClinicalTrials.gov with registration number: NCT05533853.
Informed Consent Statement: All participant’s pictures in the study were after written informed
consent was signed and obtained.
Data Availability Statement: The datasets analyzed in the current study are available from the
corresponding author on reasonable request.
Conflicts of Interest: PAO is a paid consultant for CBP NonProfit, Inc. DEH teaches is the CEO of
Chiropractic BioPhysics, owns the registered trademark, teaches rehabilitation methods, and sells
products used in this manuscript for patient rehabilitation to physicians in the USA. All the other
authors declare that they have no competing interests.

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 Journal of
Clinical Medicine

Article
The Efficacy of Cervical Lordosis Rehabilitation for Nerve Root
Function and Pain in Cervical Spondylotic Radiculopathy:
A Randomized Trial with 2-Year Follow-Up
Ibrahim M. Moustafa 1,2 , Aliaa A. Diab 2 and Deed E. Harrison 3, *

1 Department of Physiotherapy, College of Health Sciences, University of Sharjah,

Sharjah P.O. Box 27272, United Arab Emirates
2 Basic Science Department, Faculty of Physical Therapy, Cairo University, Giza 12613, Egypt
3 CBP Nonprofit—A Spine Research Foundation, Eagle, ID 83616, USA
* Correspondence: [email protected]; Tel.: +1-775-340-4734

Abstract: Sagittal cervical alignment is a clinically related feature in patients suffering from chronic
cervical spondylotic radiculopathy (CSR). We designed this randomized trial to explore the effects
of cervical lordosis (CL) correction in thirty chronic lower CSR patients with CL < 20◦ . Patients
were assigned randomly into two equal groups, study (SG) and control (CG). Both groups received
neck stretching and exercises and infrared radiation; additionally, the SG received cervical extension
traction. Treatments were applied 3× per week for 10 weeks after which groups were followed for
3 months and 2 years. The amplitude of dermatomal somatosensory evoked potentials (DSSEPS),
CL C2–C7, and pain scales (NRS) were measured. The SG had an increase in CL post-treatment
(p < 0.0001), this was maintained at 3 months and 2 years. No statistical improvement in CL was
found for the CG. A significant reduction in NRS for SG after 10 weeks of treatment with non-
Citation: Moustafa, I.M.; Diab, A.A.; significant loss of change at 3 months and continued improvement at 2 years was found. CG had
Harrison, D.E. The Efficacy of less significant improvement in post-treatment NRS; the 3-month and 2-year measures revealed
Cervical Lordosis Rehabilitation for significant worsening in NRS. An inverse linear correlation between increased CL and NRS was
Nerve Root Function and Pain in found (r = −0.49; p = 0.005) for both groups initially and maintained in SG at the final 2-year
Cervical Spondylotic Radiculopathy:
follow-up (r = −0.6; p = 0.01). At 10 weeks, we found significant improvements in DSSEPS for both
A Randomized Trial with 2-Year
groups (p < 0.0001). We identified a linear correlation between initial DSSEPs and CL for both groups
Follow-Up. J. Clin. Med. 2022, 11,
(p < 0.0001), maintained only in the SG at the final follow-up for all levels (p < 0.0001). Improved CL
6515. https://doi.org/10.3390/
in the SG correlated with significant improvements in nerve root function and pain rating in patients
jcm11216515
with CSR at short and long-term follow-up. These observed effects indicate that clinicians involved in
Academic Editors: Panagiotis the treatment of patients with symptoms of cervical degenerative disorders should add sagittal curve
Korovessis and Hiroshi Horiuchi
correction to their armamentarium of rehabilitation procedures for relevant patient populations.
Received: 21 September 2022
Accepted: 1 November 2022 Keywords: cervical spine; dermatomal somatosensory evoked potential; lordosis; randomized trial;
Published: 2 November 2022 spondylotic radiculopathy; traction

Publisher’s Note: MDPI stays neutral

with regard to jurisdictional claims in
published maps and institutional affil-
iations.
1. Introduction
Cervical spondylotic radiculopathy (CSR) is one of the most common causes of cervical
radiculopathy [1,2]. It has been documented that the incidence of cervical degenerative
abnormalities increases with age having the greatest frequency in the fifth to sixth decade
Copyright: © 2022 by the authors. of life [3]. Spondylotic degenerative findings appear to be the most common followed by
Licensee MDPI, Basel, Switzerland. disc damage and these are most common in the lower cervical spine discs (C5–C6) [3,4].
This article is an open access article The degenerative state of the intervertebral disc, vertebral body and adjacent structures,
distributed under the terms and
occurs as a result of several factors including segmental injury/trauma and alterations in
conditions of the Creative Commons
the sagittal alignment of the cervical spine; including reductions in the segmental and total
Attribution (CC BY) license (https://
angle of cervical curvature [4–7].
creativecommons.org/licenses/by/
4.0/).

J. Clin. Med. 2022, 11, 6515. https://doi.org/10.3390/jcm11216515 https://www.mdpi.com/journal/jcm

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J. Clin. Med. 2022, 11, 6515

Causation of CSR involves multiple factors but the mechanical compression and shear
loads acting on the nerve roots result in inflammation and this is the primary driver of
the pain, decreased cervical movement, and consequent neurological disturbances. CSR
incidence increases with age and has an estimated frequency of 0.35% in the fifth to sixth
decade of life [2]. Recently, multiple systematic literature reviews have been published
seeking to understand the complexities of CSM and its natural history, conservative man-
agement strategies, and the need for surgical interventions [2,8–13]. For patients with
intractable pain and with motor loss of less than three out of five, surgical intervention is
warranted [2]. However, in comparison between conservative and surgical management
trials, the long-term outcomes at 1–2 years generally show conservative care to be equally
effective for less severe CSM patients [2,8–12].
Although there is general agreement regarding the need for conservative treatment
for CSR, the precise treatment protocols for the best results and when to use them for
CSR disorders still remain an enigma [2,8–13]. Conservative treatments for CSM include
rehabilitative exercise therapy, mechanical cervical traction, transcutaneous electrical nerve
stimulation, pain management, education, cervical collars, and spinal manipulative ther-
apy [2,8–13]. Problematically, the primary outcomes in CSR populations depend on pain
measurements, which are subjective in nature, and it is rare that investigations include
measurements of neurophysiological outcomes to demonstrate improvement in nerve
root function concomitant with pain improvements [8]. One exception to this is the trial
by Moustafa and Diab [14] where they used three different cervical traction setups in
an attempt to identify the optimum angle of combined distraction with flexion, neutral,
or extension angles. The authors identified that distraction combined with slight head
extension was found to be associated with the best improvement in neurophysiological
measures in patients with cervical radiculopathy.
Regarding the development of signs and symptoms of CSR, the patho-anatomy of
the vertebra and disc is not the only cause of a given patient’s pain; it is likely that the
patho-anatomy, inflammatory mediators, functional disturbances, and altered spine align-
ment all interact to produce clinical symptoms [15]. In this regard, various studies point to
the fact that biomechanical dysfunction of the spinal column, as seen with altered cervical
sagittal plane alignment, results in degenerative changes in the muscles, ligaments, and
bony structures [4–7]; altered spine alignment coupled with degenerative spine changes
will increase the stress and strain on the neural elements potentially leading to and in-
creasing the magnitude of neurologic dysfunctions in CSR [16–21]. Clinically, the goals
of CSR patient care include sagittal plane alignment improvement in surgical [19–22] and
conservative [13–17] settings. Regarding the conservative care setting, it is rare that inves-
tigations seek to address the radiographic alignment of the sagittal cervical spine as an
outcome measure or predictive variable in CSR patients; [14,16] this may be due to the
fact that the vast majority of conservative care techniques do not have the capability to
significantly improve the shape and magnitude of the cervical lordotic curve [23–25]. The
exception to this rule is three-point bending extension traction devices which are known
to increase cervical curvature following a program of consistent care over the course of
8–12 weeks [25].
In an original collection of case studies, Pope [23] first incorporated a counter-stressing
strap system (front pull pulling posterior-anterior in the posterior aspect of the cervical
spine) to cervical extension traction with slight distraction on the skull, drawing attention to
the possibility of cervical sagittal curve correction by a ‘so-called 2 way’ cervical extension
traction. Later, in a non-randomized clinical trial, Harrison et al. [24] evaluated the effect
of this three-point bending (two-way) cervical traction on restoring the sagittal curve in
a chronic neck pain population without radiculopathy; they reported a significant increase
in cervical lordosis and reduction in pain intensity.

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In a pilot randomized trial looking at cervical spine disco-genic radiculopathy without

spondylotic changes, Moustafa et al. [16], documented that cervical extension traction,
using a novel cervical orthotic, improves the cervical lordosis and improves pain, disability,
and neurophysiology. Regarding conservative care for CSM, cervical spine traction in
flexion and distraction is one of the most commonly performed and investigated proce-
dures, but this technique is not conducive to improving the abnormal cervical lordotic
curve [2,8–13]. Furthermore, previous trials, [14,23–25] testing the effects of three-point
bending types of cervical extension traction, have not clarified the relationship of cervical
spine correction and its influence or effect on nerve root function and pain responses
associated with improving an abnormal cervical lordosis in CSR patients. In terms of
neurophysiological outcomes, dermatomal somatosensory evoked potentials (DSSEPs) can
provide reliable information about segmental nerve root function and DSSEPs have been
identified to correspond to clinical symptoms more closely than other electrophysiological
examinations [26,27].
While it is known that the conservative management of cervical spondylotic radicu-
lopathy is beneficial and multiple therapies (multi-modal) should be used simultaneously,
a recent systematic literature review concluded that neck and arm pain improvements
were ‘trivial’ at best and that further research into the best methods for specific patient
populations is needed [8]. Accordingly, in properly selected patients, cervical curve restora-
tion interventions might offer unknown benefits. Thus, the present randomized controlled
trial was undertaken to investigate the neurophysiological and pain response outcomes of
three-point bending (two-way) traction compared to standard care in patient cases with
lower cervical spine CSR, chronic pain, and with a verified hypo-lordosis of the cervical
spine. The primary hypothesis of this study was that cervical lordosis restoration will have
short and long-term effects on DSSEPs and pain outcomes in CSR patients.

2. Materials and Methods

A prospective, investigator-blinded, parallel-group, randomized clinical trial was
conducted at a research laboratory in our university and was retrospectively registered
with ClinicalTrials.gov (NCT05547997) accessed on 20 September 2022. The reason for
retrospective trial registration was that legislation in Egypt only required local registration
for clinical trials at the time of study design and this is what was conducted initially
by prospectively registration in a non-WHO-approved registry. Recruitment began after
approval was obtained from the Ethics Committee of the Faculty of Physical Therapy,
Cairo University with the ethical approval No Cairo23-987-12 M.S. All participants signed
informed consent prior to data collection.

2.1. Patients
Thirty patients with lower cervical spine CSR participated in this study. There were
nineteen females and eleven males ranging from 40 to 50 years of age. We randomly
assigned the participants into a study group and a comparative control group. The study
group, receiving three-point bending cervical traction, included nine females and six males.
The comparative treatment (control) group consisted of five males and 10 females.

2.2. Inclusion and Exclusion Criteria

Patients were included if they had unilateral radiculopathy due to spondylotic changes
of the lower cervical spine (C5–C6 and/or C6–C7). Participants were screened prior to
inclusion by measuring their lateral cervical radiographs for a cervical absolute rotation
angle (ARA) formed by two lines intersecting from the posterior body margins of C2–C7.
If the ARA angle was less than 20◦ , then participants were included in the study and
determined to have hypolordois of the cervical curve [28,29]. In addition to cervical
lordosis ≥20◦ , exclusion criteria included: (1) central spinal canal stenosis; (2) rheumatoid
arthritis; (3) vestibulobasilar insufficiency; (4) osteoporosis; (5) any disorder that might
affect the DSSEPs such as thoracic outlet syndrome, carpal tunnel syndrome, cubital tunnel

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syndrome, etc.; (6) patients who had received surgical treatment for CSR or neck injury;
(7) patients with cervical spinal instability; (8) patients with comorbid severe primary
diseases such as cardiovascular disease, cerebrovascular disease, diseases of the liver,
kidneys, or hematopoietic system; (9) patients who were suffering from any malignant
disease as well as those unable to tolerate the cervical extension position with increased
axial pain and/or radiculopathy.
The diagnostic criteria of CSR in the current study included: pain and numbness in the
distribution of spinal nerve roots C6, and/or C7; additionally, the brachial plexus tension
test or foraminal compression test had to be positive. In all participants, the location of
symptoms (e.g., dermatomal pain or neurological deficit) matched the evaluated nerve
root. Moreover, the clinical manifestations and imaging findings were consistent with their
clinical syndromes. Both plain cervical spine radiographs and MRI were used to assist in
CSR diagnosis and rule out other diseases, such as disc herniation, infection, and tumor.
Lastly, participants had to have side-to-side amplitude differences of 50% or more in their
DSSEPs measurement, a duration of symptoms of more than 3 months, and a “present”
pain score of 4 or higher on a scale of from 0 to 10. Included participants were randomly
assigned to an intervention group (n = 15) or control group (n = 15) using a random number
generator and were restricted to permuted blocks of different sizes, with the researcher
blinded to the sequence designated for each person.

2.3. Treatment Procedures

Both groups (study and control) were provided standard comparative care to improve
pain intensity and reduce muscle tension that might be responsible for a reduction in
cervical lordosis; this standard care included stretching exercises and infrared radiation
(IR). Additionally, the study group was treated with three-point bending cervical extension
traction. All participants received their respective interventions, in a controlled environ-
ment, for three days per week for ten weeks for a total of 30 sessions. Participants were
followed for 3 months and 2 years at which times re-assessments were performed.
Cervical traction procedure: The study group received three-point bending cervical
extension traction following the protocol of Harrison et al. [24]. The head halter was fixed
posteriorly to cause slight distraction, retraction, and slight extension and at the same time
a front anterior strap had weight applied over a pulley that allows transverse traction
load to be applied to the apex of the participants’ cervical curve alteration. Following the
findings of Moustafa et al. [14], the angle of the posterior head harness pull was positioned,
relative to vertical, 5–30◦ backward in order to cause slight extension and distraction as
this position was found to be associated with the best improvement in DSSEP’s in patients
with radiculopathy. Weights started at 15 lbs. (6.8 kg) on the anterior strap and increased
over consecutive visits to patient tolerance or a maximum of 35 lbs. (15.9 kg). The duration
of each session started at approximately three minutes and increased to one minute per
session until reaching the goal of 20 min per session. Figure 1 represents the cervical 2-way
traction method.
Stretching exercises: Exercises were performed in the following order: (1) stretching
towards lateral flexion for the upper part of the trapezius; (2) ipsilateral flexion and rotation
for the scalene, and (3) flexion for the extensor muscles. Each maneuver was held for 30 s
as this is an optimum time to not create an alteration in the evoked potentials [30]. Each
stretch was repeated three times. Patients performed the stretching program three times
a week for 10 weeks and this treatment took approximately 10 min per session [31].

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Figure 1. Three-point bending cervical traction. Photo reprinted with permission.

2.4. Outcome Measures

A series of outcome measures were obtained at three intervals: (1) baseline; (2) one
day following the completion of 30 visits after 10 weeks of treatment; (3) at the 3-month
follow-up after the 10-weeks of treatment re-evaluation; (4) at two years follow-up after the
10-weeks of treatment re-evaluation (1-year and 9-months after the 3-month follow-up).
The sequence of measurements was identical for all participants. Radiographic cervical
sagittal alignment of lordosis (ARA C2–C7) and neurophysiological findings were the
primary treatment outcomes, whereas, the numerical pain rating scale (NPRS) variable was
the secondary measure.

2.5. DSSEPs
The main outcome measure used to assess the nerve root function was the peak-to-peak
amplitude of dermatomal somatosensory evoked potentials (DSSEPs). An electromyogram
device (Tonneis neuroscreen plus version 1.59, Erich Jaeger, Inc., Rheda-Wiedenbrück,
Germany) was used to measure this variable for all patients before starting the treatment,
at the end of 10 weeks, at a follow-up of three months, and the long-term follow-up period
of two years. All testing procedures for DSSEPs were conducted following the protocol of
Liguori et al. [32] The patient was lying supine on a softly padded table with a pillow under
their head and knees. After the skin was abraded and cleaned with alcohol, the stimulating
electrodes were placed overlying dermatomes of C6 (about 7 cm above the styloid process
of the radius) and C7 between the second and the third metacarpal bones and at C8 (medial
side of the hand). Figure 2 demonstrates this procedure. A bipolar electrode was used
for stimulation with an inter-electrode distance of 2.5 cm with the stimulation cathode
placed proximally. The sensory threshold for the electrical stimulation was determined
by increasing the intensity of the electrical current until the patient reported its sensation,
tolerable and painless stimulus intensity was set at 2.5 times above this level. The recording
was made with 9 mm diameter tin/lead electrodes affixed with electrolyte paste to the
abraded skin. The recording electrodes were placed at C3 and C4 (between C3 and P3
and C4 and P4 of the international EEG 10–20 system), while the reference electrode was
placed at Fz and the ground electrode at Fpz. See Figure 3. The cortical responses were
amplified, averaged and displayed using an analysis time of 50 ms and a filter setting of
2 Hz to 1 kHz was used in this study. After the stimulation was performed and traces were
superimposed to ensure reproducibility, negative near-field potentials were detected to
measure the peak-to-peak amplitude.

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(a) (b)

Figure 2. Location of stimulation sites indicated by arrow (a) for the C7 dermatome and (b) for the
C6 dermatome.

Figure 3. Sites of Recording: (a) active recording electrode at c3’, (b) reference electrode at Fz, and
(c) grounding electrode at Fbz.

Cervical Lordosis: Cervical spine, standing, and lateral X-rays were obtained for
each participant at four time periods: at baseline, following 10-weeks or 30 treatment
sessions, at the 3-month follow-up, and at final follow-up of 2 years. The participants
were asked to adopt a relaxed neutral posture and look straight forward as if staring into
their own eyes in a mirror; this procedure has been investigated and has good to excellent
examiner reliability [24]. The cervical lordosis was measured using the posterior body
tangent method where a line is drawn along the posterior aspect of the C7 vertebral body
and the angle of the curve is measured with an intersecting line drawn along the posterior
vertebral body margin of C2; this is termed the absolute rotation angle or ARA of C2–C7.
The ARA C2–C7 lordosis was measured using a standard protractor and sharp X-ray pencil;
this measurement method has excellent examiner reliability [33].

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Pain intensity: Neck and arm pain intensity were measured using the numerical pain
rating scale (NPRS), which is considered a valid and reliable scale [34]. The patients were
asked to place a mark along the line to denote their pain level; 0 reflecting “no pain” and 10
reflecting the “worst pain”.

2.6. Sample Size Estimation

To determine the required number of participants needed in this study, estimates
of mean and standard deviations (SD) were collected from a pilot study consisting of
10 participants who received the same program. The mean differences and SD of the ARA
C2–C7 and peak-to-peak amplitude of DSSEPS for different levels C6, 7, and 8, were: ARA,
−7 (SD 1.2); C6: –0.6 (SD 0.1); C7: –0.7 (SD 0.2); C8: –0.6 (SD 0.3), respectively. These values
were used to calculate the sample size separately for each of the primary outcomes by
applying a Bonferroni correction to adjust the significance level. The largest value of the
sample size was then considered the final sample size for the trial. Accordingly, at least
14 participants in each group, given a statistical power of 80%, were needed in the current
study. The sample size was enlarged by 10% to account for potential dropouts.

2.7. Data Analysis

Descriptive statistics were calculated including mean ± standard deviation (SD) for
age, height and weight. For between-group repeated measures an analysis of covariance
was used: Our model used the group as an independent variable, time as the repeated mea-
surement, and group × time as the interactive variable. In order to assess between-group
differences, participants’ baseline variable outcomes were used as covariates; where each
participant’s value was subtracted from the population mean. The Bonferroni correction
was used if we identified group × time interactions, (p < 0.05). In order to assess any
possible linear correlation fits between variables, Pearson correlations between ARA C2–C7
and peak-to-peak amplitude values of DSSEPs, and ARA C2–C7 and pain scores were
determined. The correlation findings were compiled into a pre-study set and a post-study
set. The level of significance was set at p < 0.05.

3. Results
The study group, consisting of fifteen patients receiving the new extension traction,
was compared with the fifteen control participants who received standard care only (IR
and stretching exercises). Patient demographics are shown in Table 1 where it is shown
that the two groups were statistically matched for age, weight and height. Patient retention
throughout the study is shown in Figure 4.

Table 1. Baseline participant demographics.

Study Group (n = 15) Control Group (n = 15) p‡

Age (years) 46.3 ± 2.05 45.9 ± 2.1 0.5
Weight (kg) 73.3 ± 8.9 77.5 ± 9 0.2
Height (cm) 171.6 ± 5 168.3 ± 7.9 0.18
Male 6 5
0.7
Female 9 10
Smoker 5 4
0.69
Non smoker 10 11
‡ Two-sided two-sample t-test; SD: standard deviation, the values are mean (± SD) for age, height, weight and as
the number for the term ‘other’.

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J. Clin. Med. 2022, 11, 6515

Figure 4. A diagram of patients’ retention and randomization throughout the study is shown.

3.1. Pain Outcomes

At 10 weeks of treatment, pain intensity was significantly improved (p < 0.0001) for
both the study and control groups; indicating a reduction in pain due to interventions
in both groups. Using Tukey’s Multiple Comparison Test, we identified that the study
group’s pain was unchanged at the 3-month follow-up compared to the 10-week values;
p > 0.05. While at the 2-year follow-up the study group’s pain continued to improve
with a statistically significant decrease in pain at 2 years compared to 3 months, mean
difference of 1.1 and p < 0.05. In contrast, the control group revealed a significant increase
(worsening) in the mean pain at 3 months and 2 years compared to their 10 weeks of
treatment evaluation; p < 0.05 at 3 months. The between-group analysis identified that the
study group had statistically significant reductions in pain compared to the control group
at each of the three follow-up measurements; p < 0.0001. See Table 2 and Figure 5.

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Table 2. The results for the repeated measures one-way analysis of variance (ANOVA) for the absolute
rotation angle (ARA) cervical lordosis and pain intensity in both groups.

p
Measures Pretreatment At 10 Weeks At 3 Months At 2 Years Post Hoc Test (MD)
G T G×T
S 14.3 ± 4.1 20.87 ± 3 19.5 ± 3.2 18.8 ± 2.1 <0.001 <0.001 <0.001 1 vs. 2 −3.26 *
ARA C 14.6 ± 3.5 14.7± 3.3 14.1 ± 3.1 12.3 ± 2.7 1 vs. 3 −2.33 *
0.8 [−3.1–2.5] <0.001 [3.8–8.5] <0.001 [3.02–7.7] <0.001 [3.7–8.2] 1 vs. 4 −1.16 *
S 5.26 ± 0.96 3.2 ± 1.26 2.8 ± 1.27 1.71 ± 1.2 <0.001 <0.001 <0.001 1 vs. 2 1.7 *
Pain C 5.47 ± 1.18 3.9 ± 1.43 4.6 ± 1.49 4.3 ± 1.2 1 vs. 3 1.5 *
0.7 [−0.8–0.9] <0.001 [−1.7–0.29] <0.001 [−2.9–−0.79] <0.001 [−3.5–−1.8] 1 vs. 4 2.3 *
Study group: SG; Control group: CG; * Statistically significant difference: p-value; MD: mean difference.

Figure 5. Differences in pain on the numerical rating scale (NRPS) during the study reported as
mean ± SD for study and control groups at four time periods: baseline or pretreatment, after comple-
tion of the 10-week program, the 3-month follow-up, and the 2-year follow-up data. 1: pretreatment;
2: 10 weeks post-treatment; 3: at 3 months; 4: at 2-year follow-up.

3.2. ARA C2-C7 Cervical Lordosis

Regarding the cervical lordosis (ARA C2–C7), in the study group the one-way ANOVA
(baseline versus 10 weeks), identified an increased cervical lordosis ARA C2–C7, p < 0.0001
and F = 49.8. In contrast, the control group was identified to have no statistical change in
cervical lordosis; (p > 0.05). For the study group, using Tukey’s Multiple Comparison Test,
the ARA C2–C7 was unchanged at 3 months and 2 years in comparison to the 10-week
data (mean difference of 1.333 at 10-weeks; p > 0.05). In contrast, for the control group,
the post-test was not calculated due to insignificant differences; p > 0.05. The between-
group analysis identified that the study group had statistically significant increases in
ARA C2–C7 cervical lordosis compared to the control group at each of the three follow-up
measurements; p < 0.0001. See Table 2 and Figure 6.

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Figure 6. The cervical lordosis absolute rotation angle C2–C7 (ARA) for the control group and study
group is shown as the mean ± SD. Four different time periods are shown: baseline or pretreat-
ment, after completion of the 10-week program, the 3-month follow-up, and the 2-year follow-up.
1: pretreatment; 2: 10 weeks post-treatment; 3: at 3 months; 4: at 2-year follow-up.

3.3. DSSEPs
The repeated measures one-way ANOVA, comparing initial DSSEPs to 10-week treat-
ment values, identified statistically significant improvements for both groups (p < 0.0001).
A Tukey’s Multiple Comparison Test revealed significant increases in the mean of the
post-test compared with pretreatment values for both the study and controls. However,
only in the study group did the post-test reveal insignificant changes in DSSEPs at 3-month
and 2-year follow-ups compared to the 10-week data; p > 0.05. In contrast, at 3-month and
2-year follow-ups the control groups DSSEP measurements regressed back to baseline val-
ues. The between-group analysis identified that the study group had statistically significant
improvements in the DSSEPs for all three nerve root levels compared to the control group
at each of the three follow-up measurements; p < 0.0001. See Table 3 and Figures 7 and 8.

Table 3. The results for the repeated measures one-way analysis of variance (ANOVA) for the DSSEPs
amplitudes in the study and control groups for three nerve root levels: C6, C7, and C8.

p Post Hoc Test (MD)

Measures Pretreatment At 10 Weeks At 3 Months At 2 Years
G T G×T
S 0.41 ± 0.1 0.80 ± 0.19 0.79 ± 0.11 0.82 ± 0.14 <0.001 <0.001 <0.001 1 vs. 2 −0.267 *
C6 C 0.42 ± 0.2 0.56 ± 0.15 0.40 ± 0.15 0.42 ± 0.17 1 vs. 3 −0.18 *
0.8 [−0.16–0.13] <0.001 [0.11–0.37] <0.001 [0.272–0.5] <0.001 [0.31–0.48] 1 vs. 4 −0.21 *
S 0.4 ± 0.1 1.18 ± 0.33 1.0 ± 0.37 1.1 ± 0.37 <0.001 <0.001 <0.001 1 vs. 2 −0.38 *
C7 C 0.69 ± 0.2 0.7 ± 0.18 0.52 ± 0.21 0.51 ± 0.18 1 vs. 3 −0.24 *
0.05 [−0.26–0.02] <0.001 [0.32–0.72] <0.001 [0.30–0.76] <0.001 [0.36–0.81] 1 vs. 4 −0.26 *
S 0.6 ± 0.2 1.3 ± 0.5 1.4 ± 0.6 1.5 ± 0.6 <0.001 <0.001 <0.001 1 vs. 2 −0.35 *
C8 C 0.8 ± 0.2 0.9 ± 0.3 0.7 ± 0.3 0.7 ± 0.2 1 vs. 3 −0.32 *
0.15 [−0.33–0.05] 0.005 [0.17–0.84] <0.001 [0.30–1.1] <0.001 [0.32–1.08] 1 vs. 4 −0.33 *
Study group: SG; Control group: CG; * Statistically significant difference: p-value; MD: mean difference; 1: pre-
treatment; 2: 10 weeks post-treatment; 3: at 3 months; 4: at 2-year follow-up.

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Figure 7. Cont.

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Figure 7. Mean and ± SD of the DSSEPS for study and control groups at four time periods: baseline
or pretreatment, after completion of the 10-week program, the 3-month follow-up, and the 2-year
follow-up.

Figure 8. Example of DSSEPs at each of the levels C6–C8 at the four intervals of measurement for the
study group (2-way traction).

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3.4. Correlations
All correlation results for ARA C2–C7 lordosis and pain and the DSSEPs at each of the
three levels are presented as (1) a baseline correlation and (2) for follow-up treatment data
at the 2-year mark. At baseline, for both groups, increased cervical lordosis was inversely
correlated to pain intensity (r= −0.49; p = 0.005); however, this inverse correlation was only
maintained at follow-up for the study group receiving traction (r = −0.6; r= p = 0.01). See
Table 4. We identified a linear correlation between initial DSSEPs and ARA C2–C7 for both
groups at each of the three nerve root levels C6–C8 (r = 0.65, r= 0.57, r= 0.8, p < 0.0001).
Whereas this linear relationship between ARA C2–C7 became insignificant in the control
group but was maintained in the study group at a 2-year follow-up at C6 (r = 0.55; p = 0.033).
In contrast, both groups were found to have significant correlations at the 2-year mark for
C7 and C8 nerve root DSSEPs (p < 0.001). See Table 4

Table 4. Pearson correlation between ARA C2–C7 and DSSEPS and between ARA and pain. Post-
manipulating (post-treatment) data are shown for the 2-year follow-up compared to initial base-
line data.

Number of XY Pairs r p
ARA & DSSEP (C6) (baseline data) 30 0.65 <0.001 *
ARA & DSSEP (C7) (baseline data) 30 0.57 <0.001 *
ARA & DSSEP (C8) (baseline data) 30 0.8 <0.001 *
Post-manipulating data (C6) 15 0.55 0.033 *
study control 15 0.19 0.49
Post-manipulating data (C7) 15 0.74 <0.001 *
study control 15 0.62 <0.001 *
Post-manipulating data (C8) 15 0.8 <0.001 *
study control 15 0.58 <0.001 *
ARA C2–C7 and pain
30 −0.49 0.005 *
Baseline data
Post-treatment data
15 −0.6 0.01 *
Study group
Control group 15 −0.17 0.05 *
p: probability value; r: Pearson’s correlation coefficient; *: statistically significant difference.

3.5. Medication and Alternative Therapy Usage

At the 2-year follow-up, participants were asked if they were using alternative (non-
surgical) therapies and/or medications to aid in managing the frequency and intensity of
pains. Table 5 reports these interventional therapies utilized by the participants in the two
groups (Study Group and Control Group) tracked at the 2-year follow-up. The data are
reported by an individual participant in each group that the information was obtained
from and not the number of people in each group using each intervention. Thus, 11 total
participants were using medications and therapies (nine participants in the control group
and two participants in the study group) indicating alternative services and medications
were used by 4.5 times more participants in the control group and they were using a greater
number of services. Table 5.

Table 5. Medication and interventional therapies utilized by of the participants in the two groups
(Study Group and Control Group) tracked at the 2-year follow-up.

Medication Utilization & Therapy Used

Control Group
• NSAIDs
• Tricyclic antidepressants
• NSAIDs, hydrotherapy

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Table 5. Cont.

Medication Utilization & Therapy Used

• NSAIDS, Acupuncture
• Tricyclic antidepressants, semi-hard cervical collar
• Tricyclic antidepressants, semi-hard cervical collar
• Tricyclic antidepressants, soft tissue massage
• Opioid medications
• NSAIDS, Ultrasound therapy
Study Group
• NSAIDs
• Cervical spine epidural steroids
The data are reported by an individual participant in each group in each individual row that the information was
obtained from and not the number of people in each group using each intervention. Thus, 11 total participants
were using medications and therapies (nine participants in the control group and two participants in the study
group) indicating alternative services and medications were used by 4.5 times more participants in the control
group and they were using a greater number of services.

4. Discussion
This study compared outcomes of cervical spondylotic radiculopathy (CSR) in a group
receiving three-point bending cervical extension traction combined with neck stretches
and IR to a group receiving neck stretches and IR only. We had hypothesized that the
study group receiving traction would show cervical curve correction resulting in short and
long-term benefits on neurophysiological findings and improved pain. The differences
between our study and control groups’ short and long-term radiographic, DSSEPs, and
pain parameters indicate that this hypothesis is supported. This study provides objective
evidence that sagittal cervical curve malalignment, and not just pathoanatomy, influences
nerve root function and pain.

4.1. Cervical Lordosis Improvements

Concerning the cervical lordosis in the study group, a primary finding was a significant
increase in the ARA C2–C7 (mean 7.5◦ ) after 10 weeks of three-point bending traction treat-
ment with no significant loss of lordosis at 3-month and 2-year follow-up. In contrast, the
control group receiving IR and neck stretches revealed no significant differences in cervical
lordosis between baseline, 10 weeks of treatment, 3-month, and 2-year follow-up mea-
surements. Our study group’s results are in agreement with a previous non-randomized
controlled trial on three-point bending traction conducted by Harrison et al. [24] Here, [24]
three-point bending cervical traction combined with cervical manipulation was found to
improve segmental and global cervical lordosis by a mean of 14◦ in thirty-seven sessions
over the course of 8 to 10 weeks. In a pilot randomized trial on cervical radiculopathy due
to disc herniation, Moustafa and colleagues [16] demonstrated that their group receiving
a novel extension traction device termed the Denneroll, was found to have an improvement
in lordosis of approximately 13◦ after 10 weeks of care. An explanation for the reduced
cervical curve improvements (about 50% less) found in the current study compared to the
Moustafa et al. [16] and Harrison et al. [24] investigations is likely a result of the different
types of spine disorder populations being studied; chronic neck pain vs. CSR patients in
the current study and the modification to the extension traction position for CSR patients.
Though our trial is the first to assess lordotic improvements in a specific population with
CSR receiving three-point bending cervical extension traction, the results are qualitatively
comparable to previous investigations reporting cervical curve correction with these types
of traction [25].
Loss of cervical lordosis is often attributed to muscles spasm. Thus, it may be specu-
lated that our study group’s increased lordosis was attributed to the relief of muscle spasms

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and or tightness. However, we found no statistically significant differences in the control

group’s cervical lordosis who were subjected to neck stretches and IR; which should also
reduce muscle spasm/tightness. The lack of a cause-and-effect association between muscle
spasm and hypo-lordosis in our study is consistent with a study of acute and chronic neck
pain patients by Helliwell et al. [35] and with the biomechanical investigation performed
by Fedorchuk et al. [36].

4.2. Pain Improvements

Our study findings offer initial encouragement for pain management in CSR patients
using conservative care. For our control group, the transient short-term effect of traditional
exercises and IR alone are in agreement with Ylinen et al. [1] who conducted a study to
compare the effects of manual therapy and stretching exercise on neck pain and disabil-
ity. The difference in effectiveness between the two treatments was minor and low-cost
stretching exercises were recommended in the first instance as an appropriate intervention
to relieve pain, at least in the short term. The randomized trial by Levoska and Keinänen-
Kiukaanniemi [37] also found that stretching, light exercises, clay, and massage treatments
reduced the occurrence of chronic neck pain. Regarding the efficacy of traction therapy
on the outcomes of CSR, a recent randomized trial with a 3-month follows up found that
distraction traction therapy provided improvements that reached minimally important
clinical differences in about 50% of treated patients [38]. However, in a systematic literature
review, Colombo and colleagues [13] identified that, compared to matched controls, the
reduction in pain intensity after traction was statistically significant but did not reach
meaningful clinically important differences at follow-up. The conflicting, transient, and
limited effect of conservative therapies for CSR management reported in some trials is
likely multi-factorial and may be attributed to the unique variables of the individual pa-
tient. For example, sustained postural imbalance, represented by cervical hypolordosis or
kyphosis, causes increased and altered mechanical loading [4–8,20–22]. Once abnormal
sagittal cervical alignment becomes established and maintained beyond a critical threshold,
the result will be an increase in the probability of pathologies in both the soft and hard
tissues of the spine [4–7,20–22]. To this point, in both our study and control groups, we
identified a statistically significant negative correlation between cervical lordosis and neck
pain for the pre-treatment data (r = −0.49). In other words, as the cervical lordosis became
straighter, the pain intensity increased.
Of importance, comparing the 10-week to the 3-month data, there was a correlation
between the amount of change in lordosis and pain intensity for the traction group; while
there was an insignificant association for the control group. These findings indicate that
the improvement in pain intensity in the study group at 3-month and 2-year follow-up
is probably a result of restoring the cervical lordosis. Overall, our findings support a me-
chanical relationship between loss of lordosis and pain intensity in this CSR population,
particularly at long term follow-up. This mechanical relationship between loss of cervical
lordosis and neck pain has previously been identified in two separate investigations. Both
McAviney et al. [28] and Harrison et al. [29] identified moderate to good sensitivity and
specificity for a hypo cervical lordosis (less than 20◦ ) to discriminate between normal
controls and chronic neck pain subjects without significant spinal degeneration. In contrast,
in a prospective study of 107 volunteers aged over 45 years with moderate-severe degen-
eration, Grob et al. [39] examined the correlation between the presence of neck pain and
alterations in cervical lordosis concluding that the presence of such structural abnormalities
in the patient with neck pain is not related to their cause of pain.
The discrepancy and conflict regarding cervical lordosis found in the results obtained
by the previous authors [28,29,39] cannot be directly compared with our current study
for several reasons. First, the previous studies [28,29,39] were cross-sectional correlation
studies without the ability to ascribe cause and effect. Second, the selection criteria for
patient inclusion in the previous studies were patients complaining of primary lower
extremity pain in the Grob et al. [39] study and acute and chronic neck pain patients

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without CSR in the McAviney et al. [28] and Harrison et al. [29] study. In the current
study, after 30 sessions, the study group’s cervical curve closely approximated the 20◦
benchmark as reported previously [28,29]. However, note-worthy is that over the 2-year
time period, the study groups’ ARA-lordosis is becoming slightly decreased compared
to the 10-week post-treatment value. It is interesting to speculate the need for further
corrective interventional care in this group to maintain the ARA above the 20◦ mark; future
studies are needed to evaluate multiple 10-week programs of care and supportive care
over the course of 2-year follow-up in an effort to maintain the cervical curve above the
20◦ mark.

4.3. DSSEPs Improvement

We used DSSEPs to measure depressed and improved nerve root function resulting
from CSR. DSSEPs overcome the inherent problems associated with mixed nerve stimu-
lation as in the case of F wave measures and mixed nerve SSEPS will be minimized. At
10 weeks of treatment, we found statistically significant improvements in DSSEPs for both
groups (one-way ANOVA, p < 0.0001). However, at 3-month and 2-year follow-ups, the
control group’s values regressed back to baseline values whereas the traction group contin-
ued to show statistically significant improvements. Our findings indicate only a transient
effect on DSSEPs for stretching exercises and infrared radiation when used alone for the
treatment of CSR populations visible at the 10-week immediate post-treatment follow-up.
Qualitatively, our findings are in agreement with the clinical trial on CSR by Moustafa
and Diab [14] where they used three different cervical traction setups in an attempt to
identify the optimum angle of combined distraction traction. The authors identified that
distraction combined with slight head extension was found to be associated with the best
improvement in neurophysiological measures in patients with cervical radiculopathy and
this result was maintained at 1-year follow-up. Though these authors discuss their findings
relative to an abnormal cervical lordosis and the extension traction position likely benefits
the lordotic configurator; no radiographic data was supplied [14].
Significantly, we identified a linear correlation between initial DSSEPs and cervical lor-
dosis (ARA C2–C7) for both groups at initial evaluation (r = 0.65; p < 0.0001); whereas, this
relationship was only maintained in the study group at the final follow-up for all measured
cervical root levels. Thus, our findings support a relationship between abnormal cervical
lordosis and altered neurophysiological deficits on the one hand and that the consequent
improvement in neurophysiology is related to the restoration of cervical lordosis. Still,
it seems logical and, is generally accepted, that ventro-flexion traction (especially for the
lower cervical spine) is more beneficial in improving the nerve root function in CSR due
to its effects on the intervertebral foramen [12,13,38]. For example, Wainner and Gill [40]
evaluated the nonsurgical treatment of cervical disc herniations with flexion distraction and
reported that flexion distraction might be an effective therapy in the treatment of cervical
disc herniation and improving neural function as indicated by a reduction in pain. Though
contradictory as it seems, our findings support a strong correlation between lordosis in-
creases and peak-to-peak amplitude of DSSEPs for pre-and-post manipulating data. To the
best of our knowledge, this is the first study to explicitly examine these relationships in
detail in a clinical trial on CSR patients.
Mechanically, the current study findings make sense and agree with Schnebel et al. [41]
who investigated the role of spinal flexion and extension in changing nerve root compres-
sion (transverse load). It was found that the amount of compressive force and tension in
the nerve root was increased with flexion of the spine and decreased with the extension
of the spine. This tension and compression may adversely affect the CNS and nerve root
function due to the absence of any perineurium, the primary load-carrying structure [17,18].
The observations of Abdulwahab and Sabbahi [42] also correlate well with this mechanical
explanation. These authors [42] found that neck retraction appeared to increase the H
reflex amplitude in patients with radiculopathy; the opposite effect was found with cervical
flexion posture.

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The conflicts found in the results of the previous investigations and the current study
findings regarding nerve root function and flexion distraction vs. two-way extension
traction can be explained in two ways. Previous studies have referred to an increase in
the volume of the intervertebral foramen as a direct cause of decompression; while si-
multaneously disregarding the adverse mechanical tension and shear experienced by the
spinal cord and nerve roots as they make contact with any infringing pathology [17,18].
This concept is in agreement with Albert et al. [43] and supported by Brian et al. [44] who
reported that although foraminal height and foraminal area increase significantly after ante-
rior cervical discectomy and fusion in a patient with cervical radiculopathy, no correlation
was found with relief of clinical symptoms. The second reason explaining the above conflict
is that many studies [5] refer to the improvement in patient pain as a direct measure for
improvement in the nerve root function; ignoring the fact that neurophysiological deficits
in CSR often occur without overt pain or symptomatology. Pain seems to have a strong
correlation only when there is inflammation, especially when the dorsal root ganglia are
involved [45].

4.4. Limitations
The current study has several limitations, each of which points toward directions
of future study. The primary limitations were the lack of investigator blinding and the
sample was a convenient sample of patients with CSR rather than a random sample of
the whole population. Further, the sample size was just above the minimum number for
statistical significance with only 15 participants per group; 14 were needed. Larger sample
sizes in future RCTs need to be performed to confirm or refute our findings; specifically,
the 2-year follow-up in the control group where the sample size of 12 participants’ data
was just under the minimum of 14 needed for robust statistical claims to be made. Ideally,
it would have been beneficial to provide a 5-year follow-up of our population to truly
understand the impact of cervical curve restoration in the long term. However, due to the
smaller sample size of our trial (15 participants in each group), it was not possible to follow
our patients past 2-years as we would not have had enough data for statistical analysis.
Additionally, in terms of the existing conservative care literature on CSR outcomes in RCTs,
it is clear that studies use 1–2 year follow-ups as their definition of ‘long term’. In fact,
most CSR RCTs only offer 3-month to 1-year follow-up and it is rare that studies go on
for 2 years and longer [2,8–13]. Still, future investigations should provide results at 1, 2,
5-year, and 10-year follow-ups using the type of extension two-way traction as reported
in our investigation to truly understand the long-term results of curve correction in CSR.
Lastly, biomechanical investigations via computer simulation would be beneficial in future
experimental designs to understand the soft tissue deformation and strain/strain effects of
three-point-bending extension traction methods for cervical curve restoration in patients
with cervical spondylotic radiculopathy.

5. Conclusions
Our investigation identified that the correction of the cervical lordosis, in hypolordotic
spines of patients suffering from CSR, had improved pain and neurophysiology. The group
receiving three-point bending cervical traction attained a significant increase in cervical
lordosis, improvement in their pain intensity, and nerve root function measured with
DSSEPs. Follow-up measurement revealed stable improvement in all measured variables.
These observed effects of sagittal curve correction offer insights to clinicians working with
patients with cervical spine disorders such as chronic CSR. Future trials should continue to
investigate the rehabilitation of the abnormal cervical curve in CSR populations focusing on
larger sample sizes, who are the optimum candidates, what an adequate curve correction
is, and longer follow-up time periods.

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Author Contributions: I.M.M. and A.A.D. conceived the research idea and D.E.H. participated in
its design. I.M.M., A.A.D. and D.E.H. contributed to the statistical analysis. I.M.M. and A.A.D.
participated in the data collection and study supervision. I.M.M., A.A.D. and D.E.H. contributed to
the interpretation of the results and wrote the original and final drafts. All authors have read and
agreed to the published version of the manuscript.
Funding: This research received no external funding.
Institutional Review Board Statement: The study was conducted in accordance with the Declara-
tion of Helsinki and approved by the Ethics Committee of the Faculty of Physical Therapy, Cairo
University with the ethical approval No Cairo23-987-12 M.S. Recruitment began after approval was
obtained from the participants and they signed informed consent prior to data collection. The trial
was retrospectively registered with ClinicalTrials.gov (NCT05547997) accessed on 20 September
2022. The reason for retrospective trial registration was that legislation in Egypt only required local
registration for clinical trials at the time of the study design and this is what was conducted initially
by prospectively registration in a non-WHO-approved registry.
Informed Consent Statement: Written informed consent was not obtained for the person depicted
in Figure 1 as this is a photo from a model production shoot and the copyright holder is an author
(DEH) on the manuscript and has provided consent for this image to be reproduced.
Data Availability Statement: The datasets analyzed in the current study are available from the
corresponding author on reasonable request.
Conflicts of Interest: D.E.H. teaches rehabilitation methods and products to physicians for patient
care as used in this manuscript. D.E.H. is not a patent holder for the 2-way traction depicted and
described herein. All the other authors declare that they have no competing interests.

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 Journal of
Clinical Medicine

Article
Does Improvement towards a Normal Cervical Sagittal
Configuration Aid in the Management of Lumbosacral
Radiculopathy: A Randomized Controlled Trial
Ibrahim Moustafa Moustafa 1,2 , Aliaa Attiah Mohamed Diab 1,2 and Deed Eric Harrison 3, *

1 Department of Physiotherapy, College of Health Sciences, University of Sharjah,

Sharjah P.O. Box 27272, United Arab Emirates
2 Faculty of Physical Therapy, Cairo University, Giza 12511, Egypt
3 Private Practice and CBP Non-Profit, Inc., Eagle, ID 83616, USA
* Correspondence: [email protected]

Abstract: A randomized controlled study with a six-month follow-up was conducted to investigate
the effects of sagittal head posture correction on 3D spinal posture parameters, back and leg pain,
disability, and S1 nerve root function in patients with chronic discogenic lumbosacral radiculopathy
(CDLR). Participants included 80 (35 female) patients between 40 and 55 years experiencing CDLR
with a definite hypolordotic cervical spine and forward head posture (FHP) and were randomly
assigned a comparative treatment control group and a study group. Both groups received TENS
therapy and hot packs, additionally, the study group received the Denneroll cervical traction orthotic.
Interventions were applied at a frequency of 3 x per week for 10 weeks and groups were followed
for an additional 6-months. Radiographic measures included cervical lordosis (CL) from C2–C7
and FHP; postural measurements included: lumbar lordosis, thoracic kyphosis, trunk inclination,
Citation: Moustafa, I.M.; Diab, lateral deviation, trunk imbalance, surface rotation, and pelvic inclination. Leg and back pain scores,
A.A.M.; Harrison, D.E. Does Oswestry Disability Index (ODI), and H-reflex latency and amplitude were measured. Statistically
Improvement towards a Normal significant differences between the groups at 10 weeks were found: for all postural measures, CL
Cervical Sagittal Configuration Aid (p = 0.001), AHT (p = 0.002), H-reflex amplitude (p = 0.007) and latency (p = 0.001). No significant
in the Management of Lumbosacral
difference for back pain (p = 0.2), leg pain (p = 0.1) and ODI (p = 0.6) at 10 weeks were identified. Only
Radiculopathy: A Randomized
the study group’s improvements were maintained at the 6-month follow up while the control groups
Controlled Trial. J. Clin. Med. 2022,
values regressed back to baseline. At the 6-month follow-up, it was identified in the study group that
11, 5768. https://doi.org/10.3390/
improved cervical lordosis and reduction of FHP were found to have a positive impact on 3D posture
jcm11195768
parameters, leg and back pain scores, ODI, and H-reflex latency and amplitude.
Academic Editor: Panagiotis
Korovessis Keywords: randomized controlled trial; traction; disc herniation; cervical lordosis; lumbosacral radiculopathy
Received: 13 September 2022
Accepted: 24 September 2022
Published: 29 September 2022
1. Introduction
Publisher’s Note: MDPI stays neutral
with regard to jurisdictional claims in
Lumbosacral radiculopathy associated with disk herniation is one of the most common
published maps and institutional affil- health-related complaints [1]. Radiculopathy of the S1 nerve root is a frequent pathology,
iations. strongly associated with delayed recovery, persistent disability, and increased health care
utilization and costs [2]. Despite the high prevalence of this condition [3], its conservative
treatment has long remained a challenge for the clinician [4], since there is no strong
evidence of the effectiveness of most treatments, particularly for long-term management
Copyright: © 2022 by the authors. outcomes [5].
Licensee MDPI, Basel, Switzerland. The challenge clinicians face is merging an understanding of the patient’s local pathol-
This article is an open access article ogy (e.g., disc herniation) as an etiological factor of their lower back pain (LBP) with an
distributed under the terms and understanding of how altered regional and full spine alignment and biomechanics play a
conditions of the Creative Commons role in the patient’s unique condition. The interaction of tissue pathology and spine dys-
Attribution (CC BY) license (https://
function is clearly ellicudated by Murphy’s concept [6], “pathoanatomy and dysfunction
creativecommons.org/licenses/by/
4.0/).

J. Clin. Med. 2022, 11, 5768. https://doi.org/10.3390/jcm11195768 https://www.mdpi.com/journal/jcm

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often interact to produce clinical symptoms”. In terms of local biomechanical dysfunc-

tion, several investigations have identified that altered trunk posture [7,8] and lumbar
spine hypolordotic alignment [9,10] are important etiological factors contributing to the
development of and with the presence associated LBP.
In the past decade several publications have identified that head and neck alignment
plays a role in whole body pain and impairment including LBP and related disorders [11,12];
whether this is a pure mechanical phenomenon remains unclear. Studies have identified
that several of the postural upright postural neurophysiological reflexes, are located within
the head and neck region [13]. This implies that correction of the altered cervical spine
alignment could be required to achieve optimal full spine postural correction, where the
rest of the spine orients itself in a top-down fashion [14].
Besides the surgical outcomes of adult spine deformity linking head and neck align-
ment to health quality of life in thoraco-lumbar deformity patients [11,12], relatively few
correlational studies were identified linking cervical spine alignment to thoracic spine
ailments and full spine alignment to LBP [15,16]. However, considering the effect that
abnormal cervical posture (flexion and translation) has on the stress and strain experienced
in the entire spinal cord and nerve roots [17,18], it would seem logical that alterations
in cervical spine alignment would influence, at least to some extent, pain and radicu-
lopathy in lumbosacral disorders. It would seem that lumbosacral radiculopathy and
LBP conservative treatment today is universally lacking investigations seeking to under-
stand the influence of alignment of the cervical spine relative to pain, disability, and other
management outcomes [19,20].
Despite the fact that there is some evidence of a link between lower back pain disorders
and head/neck posture [11,12,21], there is limited experimental data to support a cause-
and-effect relationship and interventional outcomes. Accordingly, the primary hypothesis
of this study was that cervical curve restoration and forward head posture reduction will
have short- and long-term effects on three-dimensional (3D) spinal posture parameters as
well as lumbar radiculopathy management outcomes such as symptoms, disability, and
neurophysiological findings [19,20].
In the current study we used a cervical traction orthotic device termed the
Denneroll™ to help restore normal sagittal spinal configuration based on principles of
3-point bending traction methods [22]. The Denneroll device uses sustained cervical spine
extension loading in a prone position in order to create visco-elastic creep-deformation in
the connective tissues of the spine leading to more consistent and effective correction of the
cervical sagittal alignment. This was the primary reason for choosing this device to test our
working hypothesis.

2. Methods
A prospective, randomized, controlled study was conducted at a research laboratory
of our university. All the patients were conveniently selected from our institution’s out-
patient clinic. Recruitment began after approval was obtained from the Ethics Committee
of the Faculty of Physical Therapy, Cairo University; all participants signed informed
consent prior to data collection. Patients were recruited from May 2011 to June 2011 for
a 10-week treatment investigation with a six-month follow-up. This trial was retrospec-
tively registered at ClinicalTrials.gov (accessed on 10 September 2022) with registration
number: NCT05553002.
 Participant inclusion
Pain, disability, and symptoms: Patients were included if they had a confirmed chronic
unilateral lumbosacral radiculopathy associated with L5-S1 lumbar disc prolapse with
symptoms lasting longer than 3 months to avoid the acute stage of inflammation. All the
patients had unilateral leg pain with mild to moderate disability according to the Oswestry
Disability Index (ODI) (up to 40%) [23]. All patients had side-to-side H-reflex latency differ-
ences of more than 1 ms. Further, patients were selected with lumbar hyperlordosis (sway
back posture), which is considered a common posture aberration in CLBP patients [24].

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 Participant exclusion criteria

Exclusion criteria included previous history of lumbosacral surgery, metabolic sys-
tem disorder, cancer, cardiac problems, peripheral neuropathy, history of upper motor
neuron lesion, spinal canal stenosis, rheumatoid arthritis, osteoporosis and any lower
extremity deformity that might interfere with global postural alignment. The demographic
characteristics of the patients are shown in Table 1.

Table 1. Baseline participant demographics and tests of significance of between group variables.

Study Group (n = 40) Control Group (n = 40) p‡

Age (y) 46.3 ± 2.05 45.9 ± 2.1 0.391
Height (cm) 172 ± 9 175 ± 10 0.162
Weight (kg) 75 ± 9 80 ± 10 0.021 *
Gender 1.000
Male 22 23
Female 18 17
Work 0.087
Sedentary 25 18
Mobile 11 10
Sedentary and mobile 4 12
Previous back pain treatment (yes/no) 0.580
Surgery 0 0
Medication 29 30
Physical therapy 5 7
Other 6 3
‡: Two-sided 2-sample t test for continuous variables and Fisher’s exact test for categorical variables. SD: Standard
deviation; values are mean (±SD) for age, height, weight and number for the term ‘other’. *: Statistically significant
difference between groups for weight.

Radiography: Participants were screened prior to inclusion by measuring their lateral

cervical for a cervical absolute rotatory angle (ARA) formed by two lines intersecting from
the posterior body margins of C2–C7 and forward head distance (AHT measured as the
horizontal displacement of the posterior superior body corner of C2 vertebra relative to a
vertical line extending superiorly from the posterior inferior body corner of C7). Lateral
cervical X-rays were obtained with the participant in an upright, neutral, standing posture.
If the ARA angle was less than 25◦ and greater than 0, then a participant was included in
the study; thus, straightened and kyphotic cervical curvatures were excluded. Also, if the
AHT distance was greater than 15 mm then a participant was included in the study. These
X-ray cut-points for ARA and AHT were based on the mean values reported in the study
by Harrison et al. [25].
 Randomization assignment
The patients were randomly assigned to to either the treatment group (n = 40) or the
control group (n = 40). An independent person, blinded to the research protocol and not
otherwise involved in the trial, operated the random assignment through picking one of
the sealed envelopes which contained numbers chosen by a random number generator.
A diagram of patients’ retention and randomization throughout the study is shown in
Figure 1.

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ȱ
Figure 1. Flow of study participants.

 Interventions
The patients in both groups received hot packs (15 min) and TENS therapy to control
pain and eliminate the causal role of muscle spasms and/or tightness in changing the

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posture parameters; these procedures were applied with the patient in the prone position on
an examination bench. The TENS treatment was introduced using an electrotherapy device
(Phyaction 787, The Netherlands). The TENS therapy was delivered at the lumbosacral
region for 20 min. The frequency was set to 80 Hz and pulse width to 50 μs due to its
analgesic effect [26]. These conventional treatments were repeated three times per week
over the course of 10 weeks for 30 total sessions. Those in the control group received this
conventional treatment only.
The experimental group additionally received Deneroll cervical extension traction
(Denneroll Industries (www.denneroll.com (accessed on 10 September 2022)) of Sydney,
Australia). Here, the patient lies flat on their back (supine) on the ground with their legs
extended and arms by their sides. The patient is encouraged to relax whilst lying on the
Denneroll [22]. The Denneroll was placed on the ground and postioned in the posterior
aspect of the neck depending on the area needing to be addressed (Figure 2). Participants
were screened and tested for tolerance to the extended position on the device to insure
they were capable of performing this position; while the Denneroll takes the segments
of the cervical spine near the apex of the curve to their end range of extension motion, it
does not create hyperextension of the skull relative to the torso. See Figure 2. Patients
began with 3 min per session and progressed to a maximum of 20 min per session in an
incremental fashion.

Figure 2. The Denneroll cervical traction orthotic. The participant must lie on a firm surface, such as
the floor, and place the peak of the Denneroll just distal to the apex of their cervical lordotic abnor-
mality as shown on the lateral cervical X-ray. Shown is a mid-cervical spine placement. ©Copyright
CBP Seminars. Reprinted with permission.

The apex of the Denneroll orthotic was placed in one of three regions based on lateral
cervical radiographic displacements:

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1. In the upper cervical region (C2–C4) region. This position allows extension bending
of the upper cervical segments while causing slight anterior head translation (AHT).
One subject received this placement location.
2. The apex of the Denneroll orthotic is placed in the mid-cervical region (C4-C6) region.
This position allows extension bending of the mid-upper cervical segments while
creating a slight posterior head translation. Ten subjects received this placement
location.
3. The apex of the Denneroll orthotic is placed in the upper thoracic lower-cervical
region (C6-T1) region. This position allows extension bending of the lower to middle
cervical segments while creating a significant posterior head translation. Twenty-nine
subjects received this placement location.
 Outcome Measures
A repeatable and reliable method [27,28] was used to quantify the main outcome
measurement represented in cervical lordosis (ARA C2–C7) and any amount of anterior
head posture AHT (C2–C7). Standard lateral cervical radiographs were obtained at three
intervals (pretreatment, 10-weeks post-treatment, and at the six-month follow-up). A
representative example of a lateral cervical X-ray in a study group patient at three intervals
of measurement is given graphically in Figure 3.

Figure 3. Sample of lateral cervical X-ray findings of a participant in the study group receiving
Denneroll traction application at the three intervals of measurement. Pre-treatment prior to study
participation, 10-week post-treatment participation, and at the 6-month study follow up radiographs
are shown demonstrating improved cervical lordosis and reduced anterior head posture.

Other outcome measures used to compare effectiveness of the treatment between

the study and control groups included the 3D spinal posture parameters, disability, and
neurophysiological findings.
Rasterstereography (Formetric 2, Diers International GmbH, Schlangenbad, Germany)
was used to examine posture and back shape characteristics. All testing procedures were
done following Lippold et al.’s protocol [29]. The Formetric scans were taken in a relaxed
standing position. The patient was positioned in front of the black background screen at
a distance of two meters from the measurement system. The column height was aligned
to move the relevant parts of the patient’s back into the center of the control monitor
by using the column up/down button of the control unit; to ensure the best lateral and
longitudinal position of the patient a permanent mark on the floor was used. The patient’s
back surface (including upper buttocks) was completely bare in order to avoid image
disturbing structures.

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After the patient and the system were correctly positioned, the system was ready for
image recording. The image processing consisted of automatic back surface reconstruction
and shape analysis. The sagittale plane parameters (lumbar angles, thoracic angles, and
trunk inclination), the frontal plane parameters (trunk imbalance and lateral deviation)
and the transversal plane parameters (vertebral surface rotation and pelvis torsion) were
selected to cover the posture profile in three planes. A representative example of the
Formetric system’s print out is given graphically for a study group participant (Figure 4).

Figure 4. Formetric findings at the three intervals of measurement for a representative patient in
the study group: In the left-hand column is the sagittal plane surface profile of the thoracic and
lumbar spines while the right-hand column is the posterior view of the coronal and transverse
aspects of posture deformity for the thoracic, lumbar, and top of the pelvic regions. (A) pre-treatment;
(B) 10-weeks post-treatment; and (C) is the 6-month follow up.

Disability was measured using the Oswestry Disability Index. The total score is trans-
ferred onto a scale ranging from 0 to 100, where 0 indicates no disability and 100 indicates
worst possible disability [23].
The back and leg pain intensity were measured using the numerical pain rating scale
(NPRS), which is considered a valid and reliable scale [30]. The patients were asked to
place a mark along a line to denote their pain level; 0 reflecting “no pain” and 10 reflecting
the “worst pain”.
Latency and peak-to-peak amplitude of the H-reflex, the recommended H-reflex di-
agnostic criteria for lumbosacral radiculopathy [20], were used in the current study. An
electromyogram device (Tonneisneuroscreen plus version 1.59, Germany) was used to mea-
sure this variable for all patients before starting the treatment, at the end of 10 weeks, and
at the six-month follow-up. All testing procedures were done following Al-Abdulwahab
and Al-Jabrb’s protocol [31]. The patient was lying supine on a wooden padded table, with

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arms on the side. The knee was flexed 20 degrees by placing a small cushion under the
knee to relax the gastrocnemius muscle. The tibial nerve was stimulated at the popliteal
fossa, midway between the tendon of the biceps femoris and semimembranosus, using
a silver–silver chloride surface-stimulating bar electrode with the cathode proximal to
the anode.
For recording, surface bar electrodes were placed 3 cm distal to the bifurcation of
the gastrocnemii and superior to the Achilles tendon. A ground surface metal electrode
was positioned midway between the stimulation and recording electrodes to minimize the
stimulus artifact. Before attaching the recording electrodes, the underlying skin was shaved
and cleaned with a piece of cotton soaked with alcohol. The stimulation parameters were
1.0 ms pulse duration and intensity that elicited H-maximum with minimum and stable M-
response at a frequency of 0.2 Hz. Four readings of the maximum H-reflex with minimum
and stable M-responses were recorded and averaged from the involved leg. The signals
were amplified 500–2000 × using differential amplification and filtered at 3 Hz–10 kHz,
digitized (10 kHz) and stored on a computer for analysis.
 Sample size determination
A prior power calculation indicated that 27 patients were needed in each group to
detect a difference in cervical lordotic angle between the groups with 90% power and a
5% significance level; a 2-tailed test, and an expected effect size of d = 0.9 based on a pilot
study consisted of 10 patients who received the same program. The sample size estimation
was based on an unpublished pilot randomized controlled clinical trial that used a similar
protocol for patients with discogenic lumbosacral radiculopathy. The population was in
the same age range with minimal change in the control treatment (stretching vs. hot backs
herein). In this pilot, the traditional therapy was TENS, back and lower limb stretching
exercises, and ARA C2–C7 cervical lordosis for our primary outcome. The pilot project
had no long-term follow-up; therefore, the sample size was calculated based on pre-post
lordosis changes. The mean change and standard deviation of the cervical lordosis were
estimated at 3.2 and 3.7, respectively. To account for the possibility of significant drop-out
rates, the sample size was increased by 40%.
 Data analysis
To compare the experimental group and the control group, statistical analysis was
based on the intention-to-treat principle, and p-values less than 0.05 were considered
significant. We used multiple imputations to handle missing data. To impute the missing
data, we constructed multiple regression models including variables potentially related to
the fact that the data were missing and also variables correlated with that outcome. We
used Stata (Stata Corp, College Station, TX, USA). The 2-way repeated-measures analysis
of covariance was used to compare between groups. The model included one independent
factor (group), one repeated measure (time), and an interaction factor (group * time). The
baseline values of the outcomes were used as covariates to assess the between-group
differences, to center the baseline covariates, everyone’s score value was subtracted from
the overall mean. A t-test at two follow-up points (after 10 weeks of treatment and at
the six-month follow-up) was performed to test the between group differences at the
different intervals.

3. Results
A diagram of patients’ retention and randomization throughout the study is shown
in Figure 1. One hundred and fifty patients were initially screened. After the screening
process, 84 patients were eligible to participate in the study and 80 completed the first
follow up at 10 weeks, while 71 of them completed the entire study including the 6-month
follow up. The study design did not include a pre-determined adverse event protocol.
However, participants were formally asked during their treatment sessions if they were
experiencing any unusual adverse events or increased pain due to the interventions. No
adverse events were documented by the treating therapist aside from minimal and transient

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discomfort in the neck as the patient acclimatized to using the Denneroll device at the point
of cervical spine contact.
Results are summarized and presented as mean (±SD) in Table 2. After 10 weeks of
treatment, the analysis of covariance (ANCOVA) revealed a significant difference between
the study and control groups adjusted to baseline values for all following variables: ARA
(p = 0.001), AHT (p = 0.002), neurophysiological findings represented in H-reflex amplitude
(p = 0.007) and H-reflex latency (p = 0.001); 3D postural parameters in terms of trunk
inclination (p = 0.001), lumbar lordosis (p = 0.002), thoracic kyphosis (p = 0.001), trunk
imbalance (p = 0.001), pelvic inclination (p = 0.005), and surface rotation (p = 0.01).

Table 2. Means, standard deviations (±SD), and statistical significance for all outcome variables in
the control group versus the study subjects at initial, 10 weeks of treatment, and 6-month follow up.

Initial 10-Weeks 6-Month p-Value

Dependent Variables Baseline Post Follow Up
G T G*T
Study G 6 ± 1.0 5.1 ± 1.1 5.5 ± 1.4
<0.001 <0.001 <0.001
Trunk inclination Control G 6.7 ± 1.3 6.5 ± 1.1 6.8 ± 1.3
Between group analysis 0.01 0.04
Study G 64.9 ± 4.2 62.0 ± 5.3 63.1 ± 5.1
<0.001 <0.001 <0.001
Thoracic kyphosis Control G 62.2 ± 4.9 61.5 ± 4.9 61.9 ± 5.2
Between group analysis 0.001 0.001
Study G 49.5 ± 3.4 46.7 ± 3.5 47.1 ± 3.3
<0.001 <0.001 <0.001
Lumbar lordosis Control G 49.1 ± 3.2 48.3 ± 3.2 48.9 ± 3.4
Between group analysis 0.002 0.001
Study G 20.4 ± 2.9 17.4 ± 2.8 17.8 ± 2.7
<0.001 <0.001 <0.001
Trunk imbalance Control G 20.1 ± 2.9 19.3 ± 2.4 19.5 ± 2.6
Between group analysis 0.001 <0.001
Study G 3.2 ± 0.6 1.9 ± 0.8 2.0 ± 1
<0.001 <0.001 <0.001
Pelvic inclination Control G 3.0 ± 0.6 3.0 ± 0.9 3.3 ± 0.8
Between group analysis 0.005 0.02
Study G 5.6 ± 1.1 5.01 ± 1.3 5.6 ± 1.6
<0.001 <0.001 <0.001
Surface rotation Control G 6.4 ± 1.0 6.3 ± 0.9 6.7 ± 1.0
Between group analysis 0.01 0.05
Study G 13.3 ± 3 18.25 ± 2.6 17.6 ± 2.8
<0.001 <0.001 <0.001
+ Cervical ARA Control G 13.5 ± 2.7 14 ± 2.8 14 ± 2.9
Between group analysis 0.001 0.01
Study G 29 ± 5.6 25.3 ± 5.4 25 ± 5
<0.001 <0.001 <0.001
Functional index Control G 31.9 ± 5.8 31.6 ± 5.5 33 ± 6.2
Between group analysis 0.6 <0.001
Study G 2.4 ± 0.3 2.8 ± 0.4 2.7 ± 0.3
<0.001 <0.001 <0.001
H-reflex amplitude Control G 1.9 ± 0.2 2.1 ± 0.4 2 ± 0.6
Between group analysis 0.007 <0.001

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Table 2. Cont.

Initial 10-Weeks 6-Month p-Value

Dependent Variables Baseline Post Follow Up
G T G*T
Study G 33.5 ± 0.7 32.4 ± 0.7 32.5 ± 0.6
<0.001 <0.001 <0.001
H-reflex latency Control G 33.8 ± 0.6 33.5 ± 1.1 34 ± 2.1
Between group analysis 0.001 0.004
Study G 5.2 ± 0.8 3.5 ± 1.1 3.3 ± 1.5
<0.001 <0.001 <0.001
Back pain Control G 4.6 ± 1 3.4 ± 1 4.7 ± 1.5
Between group analysis 0.27 <0.001
Study G 6.9 ± 0.7 4.8 ± 1.3 4.7 ± 1.5
<0.001 <0.001 <0.001
Leg pain Control G 6.4 ± 1.1 4.7 ± 1.4 6.1 ± 1.6
Between group analysis 0.1 <0.001
Study G 26.5 ± 5.7 21 ± 5.3 22.0 ± 5.3
<0.001 <0.001 <0.001
++ AHT Control G 26.1 ± 3.9 24.9 ± 3.8 25.3 ± 3.2
Between group analysis 0.002 0.028
T2-way repeated-measures analysis of covariance was used to compare between groups. The model included
one independent factor (group: G), one repeated measure (time: T), and an interaction factor (group * time: G*T).
+ ARA: Absolute rotation angle for cervical lordosis along the backs of vertebral body margins of C2 and C7.
++ AHT: Forward or anterior head translation posture.

At the six-month follow-up, the analysis showed that there were still significant differ-
ences between the study and control groups for all the previous variables: radiographic
measurements of cervical lordosis ARA (p = 0.01), AHT (p= 0.028); neurophysiological find-
ings represented in H-reflex amplitude (p < 0.001) and H-reflex latency (p = 0.004); as well
as the 3D postural parameters of trunk inclination (p = 0.04), lumbar lordosis (p = 0.001),
thoracic kyphosis (p = 0.001), trunk imbalance (p < 0.001), pelvic inclination (p = 0.02),
and surface rotation (p = 0.05). Table 2 presents this data. Figure 3 depicts an example of
radiographic changes in the study group across the 3 time periods of evaluation. Figure 4
depicts an example of the 3D posture changes in the study group across the 3 time periods
of evaluation.
At the 10-week post-treatment analysis, for back pain, leg pain and the ODI disability
index, the between group analysis revealed insignificant difference between the groups at
the first measurement interval: back pain, p = 0.27; leg pain, p = 0.1; and ODI, p = 0.6. In
contrast, at the 6-month follow up, there was statistically significant differences between
the groups for back pain (p < 0.001), leg pain (p < 0.001), and ODI (p < 0.001). These
data are reported in Table 2. Specifically, the 6-month follow up data indicated that the
control group’s scores regressed back to pre-intervention levels while the study groups’
improvements in these variables were maintained.

4. Discussion
This study tested the hypothesis that correction of sagittal cervical alignment would in-
fluence management outcomes of chronic lumbosacral radiculopathy. We compared TENS
and hot packs in a control group to the outcomes of a study group receiving the control in-
terventions plus the addition of an extension cervical traction device (the Denneroll) known
to correct sagittal cervical spine alignment. [22] As expected, after 10 weeks of treatment,
the study group (traction group) was found to have improvements in the cervical lordosis
and anterior head translation compared to no change in the control group. Additionally, at
10 weeks, the study group was found to have improved 3D thoraco-lumbar-pelvic posture
as well as improved neurophysiology as measured with the H-reflex.
Unexpectedly, the patient perceptive outcomes of lower back pain, leg pain, and lower
back disability showed no differences between the groups; both groups improved equally at

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10 weeks of treatment. However, after the 6-month follow-up with no further interventions,
the control groups improvements regressed back to baseline values while the study group
showed improved lumbar radiculopathy management outcomes for all variables. Thus,
the difference in our study groups 6-month outcomes compared to the control group of
improved radiographic, 3D postural parameters, clinical, and neurophysiological variables
all indicate that our hypothesis is supported; improved cervical sagittal alignment does
have a significant effect on the management outcomes of lumbosacral radiculopathy.
 Back pain, leg pain improvements at 10 weeks
The outcomes of back pain, leg pain, and disability for both the study group and
control group showed similar improvements at the 10-week post-treatment assessment.
The temporal reduction of pain in both our groups can be attributed to the short-term effect
of TENS and hotpacks. For instance, Escortell-Mayor et al. [32] reported that the effect of
TENS significantly decreased 6 months after the intervention. Similarly, the systematic
review of Gaid and Cozens [33] provides evidence to support the use of TENS as a short-
term effective treatment modality for chronic lower back pain. This is likely the explanation
for the worsening (waning of treatment effect) of pain and disability in our control group
at 6 months.
 Sagittal Cervical Alignment
The improvement in the forward head posture and cervical lordotic curve recorded
by the study group receiving the Denneroll was anticipated in as much as previous in-
vestigations have identified that this device does indeed improve the cervical lordosis
and reduce anterior head translation [22]. Sustained extension loading on devices like the
Denneroll causes stretching of the visco-elastic tissues (discs, ligaments, muscles) of the
cervical spine in the direction of the neutral head and neck posture and increased lordosis;
this is the likely explanation and rationale for sustained extension loading restoring the
cervical lordosis and improving anterior head translation [22,34,35].
Our study identified a smaller mean improvement in cervical lordosis compared to
previous investigations using extension traction devices [22,34,35]. These smaller mean
changes are likely a result of our use of only 30 sessions on the Denneroll and the pre-
determined inclusion criteria of hypolordosis with AHT, thoracic hyperkyphosis, and
lumbar hyperlordosis for subject participation. It is possible that if we allowed straight and
reversed cervical curves in our population, the corrections would have been greater as the
potential for improvement would be more. We suggest it is likely that the improved cervical
sagittal alignment played a role in the improved outcomes of lumbosacral radiculopathy in
our study group for the reasons discussed below.
 3-D Posture Changes
The study group receiving the Denneroll traction experienced significant changes in
posture parameters occurring in the sagittal, transverse, and coronal planes. These postural
changes suggest an important role for the cervical spine on global spinal posture via
complex neurophysiological reflex mechanisms [13]. For instance, studies have identified
neurological regulation of static upright human posture that is largely dependent on head
posture [36,37] and consequently a normal joint afferentation process.
Our results are conceptually in agreement with Lewit [31] who highlighted the associa-
tion between head posture and the pelvo-ocular reflex, where an anterior pelvic translation
to balance the head’s center of gravity may occur; this interdependence between body
segments has been reported by others as well [38,39]. Additionally, in the study group
receiving the Denneroll traction, the resultant changes in the sagittal contour of the whole
spine may have contributed to the significant improvements of posture parameters in the
transverse and coronal planes as well. For example, the relationship between the sagittal
and coronal spinal contours [40–42] and between the sagittal configuration of the spine and
axial rotation displacements [43] has been detailed.

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It is likely that the continuous asymmetrical loading from altered postures (forward
head posture, loss of cervical lordosis, sagittal, transverse and coronal displacements) may
be the possible explanation for the decline in the functional status for the control group at
the 6-month follow up as supported by predictions from experimental and biomechanical
spine-posture modelling studies [44,45], surgical outcomes [11,12] and large cohort investi-
gations [15]. Abnormal posture is considered as a predisposing factor for pain because it
elicits abnormal stresses and strains in many structures, including bones, intervertebral
discs, facet joints, musculotendinous tissues, and neural elements [11,12,17,18,44,45]. Thus,
the 6-month improvement of pain for the study group seems reasonably attributable to the
restoration of normal posture.
In contrast to our findings, other studies in the literature have reported that postural
abnormalities were of minor importance for LBP and disability [46–48]. The lack of a
clear correlation between sagittal spine curves and health was suggested in a systematic
review conducted by Christensen and Hartvigsen [47]. However, the contradictory findings
between the correlation between posture and pain in previous studies might simply be
due to a lack of uniform classification and measures; most of the previous research is
based on 2D posture analysis and poor experimental design. Further, when taken as a
whole, comprehensive literature reviews including systematic literature reviews and meta-
analyses on the topic, suggests a correlation between sagittal plane posture and patient
outcomes [11,12,15,49,50]; especially in the cervical spine [51–53].
 Neurophysiological improvements
The current investigation assessed neurophysiological responses at the nerve root by
evaluating the H-reflex. Notably, we identified significantly improved H-reflex latency and
amplitude in the study group compared with the control group at the 10-week evaluation
and this improvement was maintained at the 6-month follow-up. The only explanation that
seems reasonable herein, is that improved posture and cervical spine alignment in the study
group reduced longitudinal stress and strain in the central nervous system and in the lum-
bosacral nerve roots. This concept is supported by biomechanical investigations confirming
that abnormal posture of any part of the spinal column will induce abnormal stresses in the
entire cord and nerve roots while normal posture will minimize these stresses [17,18]. This
concept of altered postures of the thoraco-lumbar spine increasing tension on the nerve
root and increasing the likelihood of radiculopathy has been documented elsewhere [54].
Specific to the cervical spine, Breig and Marions [18] demonstrated the effect that slight
cervical spine flexion (straightening of the cervical lordosis) has on the lumbosacral nerve
roots where increased tension was found as far down as the cauda equina and the sacral
plexus. With loss of the cervical lordosis causing increased tension in the lumbosacral nerve
roots, a disc herniation in the lumbosacral region would be associated with an increased
shear load at the interface between the disc and the nerve root [17]. Finally, it has recently
been confirmed that improvement of the sagittal cervical radiographic alignment does
improve neurophysiological amplitudies and latencies of somatosensory evoked potentials
in the cervical spine, both measured in the peripheral (nerve root) and central systems
(central condition time) [22,55]. Thus, it seems logical that our study findings indicate that
improved cervical sagittal alignment and improved 3D posture were the explanations for
the improvements in the H-reflex identified in our study group.
 Study limitations
Our study has some potential limitations, each of which points towards directions of
future investigations. The primary limitations were the lack of investigator blinding and
the sample was a convenient sample rather than a random sample of the whole population.
Further, it remains to be seen what effect a greater frequency and number of traction
sessions will produce and what effect the Denneroll would have on improvement of altered
cervical curves with other types of primary lumbar disorders.

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5. Conclusions
Our study identified that both groups experienced improvement in lower back pain,
leg pain and disability levels after 10 weeks (30 sessions) of interventions. However, cervical
lordosis, 3D posture of the trunk and the neurophysiological findings, represented in the
H-reflex, identified greater improvements in the study group receiving the Denneroll. At
the 6-month follow up, the control groups improvement in lower back pain, leg pain and
disability reverted back to pre-study values. In contrast, at the 6-month follow-up the
Denneroll traction study group showed improvements in all variables, including lower
back pain, leg pain, disability, the 3D posture parameters, neurophysiological, and sagittal
cervical alignment. These findings suggest that improving the cervical sagittal radiographic
alignment offers benefits to this population suffering from chronic lower back pain and
lumbosacral radiculopathy.

Author Contributions: I.M.M., A.A.M.D. and D.E.H. conceived the research idea and participated
in its design. I.M.M., A.A.M.D. and D.E.H. all contributed to the statistical analysis. I.M.M. and
A.A.M.D. participated in the data collection and study supervision. I.M.M., A.A.M.D. and D.E.H. all
contributed to the interpretation of the results and wrote the original and final drafts. All authors
agree with the order of presentation of the authors. All authors have read and agreed to the published
version of the manuscript.
Funding: This research project received funding of the cervical Dennerolls used for the participants
from CBP NonProfit, Inc. Eagle, ID, USA (836161).
Institutional Review Board Statement: The study was conducted in accordance with the Declara-
tion of Helsinki and approved by the Ethics Committee of the Faculty of Physical Therapy, Cairo
University; all participants signed informed consent prior to data collection. This trial was retro-
spectively registered at ClinicalTrials.gov (accessed on 10 September 2022) with registration number
(NCT05553002).
Informed Consent Statement: Written informed consent was not obtained for the person depicted
in Figure 2 as this is a photo from a model production shoot and the copyright holder is an author
(D.E.H.) on the manuscript and has provided consent for this image to be reproduced.
Data Availability Statement: The datasets analyzed in the current study are available from the
corresponding author on reasonable request.
Conflicts of Interest: D.E.H. teaches rehabilitation methods and sells the Denneroll products to
physicians for patient care as used in this manuscript. D.E.H. is not a patent holder for the Denneroll
products. All the other authors declare that they have no competing interests.

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 Journal of
Clinical Medicine

Article
Randomized Feasibility Pilot Trial of Adding a New
Three-Dimensional Adjustable Posture-Corrective Orthotic
to a Multi-Modal Program for the Treatment of Nonspecific
Neck Pain
Ahmed S. A. Youssef 1,2 , Ibrahim M. Moustafa 3 , Ahmed M. El Melhat 4,5 , Xiaolin Huang 1 ,
Paul A. Oakley 6 and Deed E. Harrison 7, *

1 Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of
Science and Technology, 1095#, Jiefang Avenue, Wuhan 430030, China
2 Basic Science Department, Faculty of Physical Therapy, Beni-Suef University, Beni-Suef 62521, Egypt
3 Department of Physiotherapy, College of Health Sciences, University of Sharjah, University City,
Sharjah 27272, United Arab Emirates
4 Department of Physical Therapy for Musculoskeletal Disorders and their Surgeries, Faculty of Physical
Therapy, Cairo University, Cairo 12613, Egypt
5 Department of Physical Therapy, Faculty of Health Sciences, Beirut Arab University,
Beirut P.O. Box 11-5020, Lebanon
6 Independent Researcher, Newmarket, ON L3Y 8Y8, Canada
7 CBP NonProfit, Inc., Eagle, ID 83616, USA
* Correspondence: [email protected]

Abstract: The aim of this study was to investigate the feasibility and effect of a multimodal program
Citation: Youssef, A.S.A.; Moustafa,
for the management of chronic nonspecific neck pain CNSNP with the addition of a 3D adjustable
I.M.; El Melhat, A.M.; Huang, X.; posture corrective orthotic (PCO), with a focus on patient recruitment and retention. This report
Oakley, P.A.; Harrison, D.E. describes a prospective, randomized controlled pilot study with twenty-four participants with
Randomized Feasibility Pilot Trial of CNSNP and definite 3D postural deviations who were randomly assigned to control and study
Adding a New Three-Dimensional groups. Both groups received the same multimodal program; additionally, the study group received
Adjustable Posture-Corrective a 3D PCO to perform mirror image® therapy for 20–30 min while the patient was walking on a
Orthotic to a Multi-Modal Program treadmill 2–3 times per week for 10 weeks. Primary outcomes included feasibility, recruitment,
for the Treatment of Nonspecific adherence, safety, and sample size calculation. Secondary outcomes included neck pain intensity by
Neck Pain. J. Clin. Med. 2022, 11,
numeric pain rating scale (NPRS), neck disability index (NDI), active cervical ROM, and 3D posture
7028. https://doi.org/10.3390/
parameters of the head in relation to the thoracic region. Measures were assessed at baseline and
jcm11237028
after 10 weeks of intervention. Overall, 54 participants were screened for eligibility, and 24 (100%)
Academic Editor: Hiroshi Horiuchi were enrolled for study participation. Three participants (12.5%) were lost to reassessment before
Received: 12 September 2022
finishing 10 weeks of treatment. The between-group mean differences in change scores indicated
Accepted: 21 November 2022 greater improvements in the study group receiving the new PCO intervention. Using an effect size of
Published: 28 November 2022 0.797, α > 0.05, β = 80% between-group improvements for NDI identified that 42 participants were
required for a full-scale RCT. This pilot study demonstrated the feasibility of recruitment, compliance,
Publisher’s Note: MDPI stays neutral
and safety for the treatment of CNSNP using a 3D PCO to a multimodal program to positively affect
with regard to jurisdictional claims in
CNSNP management.
published maps and institutional affil-
iations.
Keywords: neck pain; orthotic; mirror image® therapy; reverse posture training

Copyright: © 2022 by the authors.

Licensee MDPI, Basel, Switzerland. 1. Introduction
This article is an open access article Chronic nonspecific neck pain (CNSNP) is a common musculoskeletal disorder world-
distributed under the terms and
wide. Because of CNSNP, disability-adjusted life years increased from 17 million (95% con-
conditions of the Creative Commons
fidence interval (CI), 11.4–23.7) in 1990 to 29 million (95% CI, 19.5–40.5) in 2016 [1,2]. Treat-
Attribution (CC BY) license (https://
ment of CNSNP according to the clinical guidelines of APTA [3] includes manual therapy,
creativecommons.org/licenses/by/
therapeutic exercises, and posture education or correction. A study by Bernal-Utrera et al.,
4.0/).

J. Clin. Med. 2022, 11, 7028. https://doi.org/10.3390/jcm11237028 https://www.mdpi.com/journal/jcm

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2020 concluded that manual therapy achieved a faster reduction in pain perception than
therapeutic exercise, but therapeutic exercise reduced disability faster than manual ther-
apy [4].
Although the exact relationship between posture and CNSNP is unsettled, poor
posture of the cervical spine appears to influence dorsal neck muscle activity at rest and
during movement [5]. Additionally, forward head posture (FHP) is associated with thoracic
hyper-kyphosis and indirectly affects cervical flexion and the rotational range of motion
(ROM) [6]. In addition, sustained computer work and prolonged use of smartphones
appear to modify neck posture, as well as scapular positioning and upper trapezius muscle
activity [7,8].
A recent systematic review conducted by Szczygieł et al., 2020 found that the posture
of the head has a significant effect on the human body [9]. Abnormal head positions affect
muscle activity, proprioception, and respiratory patterns and contribute to neck pain [9].
Another review, by Anabela et al., 2009 [10], concluded that head posture assessment is
useful for neck patients, but it must be considered in relation to the patient’s symptoms
and related functional problems [11–13].
Harrison [14,15] detailed posture displacements of the head, ribcage, and pelvis in
three dimensions (3D) as translations and rotational displacements. Therefore, 3D postural
assessment and correction during the treatment of CNSNP or postural neck pain should
be considered [9,11]. There is also a growing body of research regarding patients with
spinal dysfunction using mirror image® therapy, which is prescribed specifically to help
normalize the patient’s neuromuscular dysfunction and postural deformation by reflecting
the patient’s posture across different planes [14–17]. The majority of interventions for
improvement of abnormal posture focus on single or double combination movements (e.g.,
1 or 2 movements at a time) as it is difficult to maneuver a patient’s head and neck in
multiple planes and postures at once [14–17].
In the current investigation, we designed an adjustable 3D posture corrective orthotic
(PCO) for the patient to wear for a short time (patent number CN201921929736.1). The
PCO has the ability to reflect all translation and rotational displacements of the head in
combination (3D planes). This mirror image therapy is designed to be delivered via the use
of the adjustable PCO while the patient is walking at approximately 2–3 miles per hour on
a standard, motorized treadmill. The PCO reverses the poor posture according to the 3D
posture analysis data.
To the best of our knowledge, no randomized controlled trial (RCT) has evaluated
the addition of a 3D adjustable PCO to a care program and investigated the short-term
improvement effects on CNSNP management outcomes. The primary aim of our study was
to perform a pilot RCT investigation to evaluate the feasibility of conducting a full-scale
RCT considering recruitment, compliance to study protocols, adverse events, adherence,
sample size calculation, and safety. The secondary aim was to investigate the effect size of
adding the 3D PCO for mirror image therapy (reverse posture training) while the patient
is walking on a motorized treadmill compared to a control group receiving standard
interventions for neck pain intensity, disability, active ROM and 3D posture parameters
after 10 weeks of intervention.

2. Methods
2.1. Study Design
This study was a double-blind (the different investigators and outcome assessor were
blinded to group allocation) superiority pilot RCT with 2 parallel groups. The study was
performed according to CONSORT guidelines. The ethics committee of Tongji Hospital,
Tongji Medical College, Huazhong University of Science and Technology (HUST), Wuhan,
China, approved the study protocol (certificate of approval number TJ-IRB20170703),
which was prospectively registered at clinicaltrials.gov (Id: NCT03331120). The study was
performed in the rehabilitation department at Tongji Hospital, affiliated with HUST, China.

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2.2. Procedures
Participants were recruited through advertisements in orthopedic and rehabilitation
department clinics and via mobile applications, such as WeChat (Tencent Ltd., Shenzhen,
China). Participants first completed a written informed consent form, provided demo-
graphic data, and completed patient-reported outcome measures, including numeric pain
rating scale score (NPRS) and neck disability index (NDI). Then, the outcome assessor mea-
sured the rotational and translational displacements of the head in relation to the thoracic
region using a global postural system (GPS) device. After eligibility confirmation, another
research assistant randomized participants to either a study or a control group receiving
standard interventions only using sealed numbered envelopes using a randomization
list generated by a random integer generator (www.random.org). A blinded investigator
performed all outcome assessments at baseline and after 10 weeks of intervention. Partici-
pants were not blinded to their group allocation because of the difference in interventions
between the two groups.

2.3. Participants
2.3.1. Inclusion Criteria
Male and female participants aged 17–40; Ability to continue treatment for 10 weeks;
Signature on informed consent form; Neck pain that was equal to or greater than 3/10 on
the NPRS and pain lasting more than 3 months (chronic neck pain) [18,19]; A neck disability
score on the NDI of at least 5 from a total score of 50 [20]; A 3D postural assessment, known
as the Global Posture System (GPS) 600, (Chinesport, Udine, Italy).

2.3.2. Posture Translations Displacements Included the Following

Anterior head translation (Tz) more than 2.5 cm [21,22]; Side shifting of the head (Tx)
in relation to the thoracic region of more than 0.5 cm [16].

2.3.3. Posture Rotations Displacements Included the Following

Rotation of head about vertical gravity (Ry) more than or equal to 3◦ [23]; Side bending
of head (Rz) more than or equal to 3◦ [10]; Flexion or extension position of head (Rx).
The average angle is 18◦ ; if the angle was greater than this, it means extension in the
upper cervical region, and if it is less, it means flexion in the upper cervical region [10].
Participants were included if they had at least two posture displacements, whether they
were translations or rotations. We included more obvious amounts of translations of the
head posture related to the thoracic region to avoid variability of measurement between
participants such that the posture deviations could be visually examined. The mean
absolute differences within examiners’ measurements (MADOMs) were 0.4 cm or less for
lateral translations (Tx Head, Tx Thoracic, and Tx Pelvic) and 0.71 cm or less for forward
translational measurements (Tz Head, Tz Thoracic, and Tz Pelvic). The MADOMs were
3.2◦ or less for flexion-extension rotational measurements (Rx Head, Rx Thoracic, and Rx
Pelvic) and 1.4◦ or less for all axial rotations (Ry Head, Ry Thoracic, and Ry Pelvic) and
lateral bending rotations (Rz Head, Rz Thoracic, and Rz Pelvic) [23].

2.3.4. Exclusion Criteria

Neck pain associated with whiplash injuries, medical red flag history (such as tu-
mor, fracture, metabolic diseases, rheumatoid arthritis, or osteoporosis) [19]; Neck pain
with cervical radiculopathy or associated with externalized cervical disc herniation [19];
Fibromyalgia syndrome, because its diagnosis is similar to that of CNSNP [24]; Surgery
in the neck area, regardless of the cause neck pain accompanied by vertigo caused by
vertebra-basilar insufficiency or accompanied by non-cervicogenic headaches [19]; Current
pain treatment, psychiatric disorders, or another problem that would contraindicate the
use of the techniques in this study [19]; Any of the following conditions: (1) history of
cervical or facial trauma or surgery, (2) congenital anomalies involving the spine (cervical,
thoracic, or lumbar), (3) bony abnormalities, such as scoliosis, (4) any systemic arthritis,

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(5) recurrent middle ear infections over the last 5 years or any hearing impairment requiring
the use of a hearing aid, (6) persistent respiratory difficulties over the last 5 years that
necessitated absence from work, required long-term medication, or interfered with daily
activities, (7) any visual impairment not corrected by glasses, (8) any disorder of the central
nervous system, or (9) pregnancy or breast-feeding because these conditions affect head
posture [25–28]; Inability to attend a 10-week treatment program.

2.4. Examination Procedures

All participants had histories taken. The history included demographic variables
(age, sex, the mode of onset, duration of symptoms, nature and location of symptoms, and
mechanism of injury, if it happened previously), as well as questions regarding aggravating
and relieving factors, such as posture modifications and changed positions and any prior
history of NP. All patients had a recent MRI study, no more than two weeks before the start
of the study. In addition to the MRI. In addition to the MRI, other tests were performed to
rule out the presence of space-occupying masses such as tumors, extruded intervertebral
disks, osteophytes, nerve root irritation, or radiculopathy (specific neck pain), such as
the Valsalva test, Spurling test (Foraminal compression test), distraction test, and Jackson
compression test, followed by reflexes, cutaneous distribution, joint play movements,
palpation, and diagnostic imaging. All participants underwent a physical examination.
Pain level, neck function, and 3D posture analysis of the head in relation to the thoracic
region and active cervical range of motion were measured before and after treatment [3,29].

2.4.1. Primary Outcomes

The primary outcome of our study was to determine the feasibility of conducting
an RCT; thus, we monitored the integrity of the study protocol, recruitment and reten-
tion, randomization procedures, primary outcome measures, and the sample-size calcu-
lation [30–32]. Further details and the results of each aspect of the primary outcomes are
provided in the results section.

2.4.2. Secondary Outcomes

(1) Numeric pain rating scale (NPRS)
The NPRS is an 11-point numeric pain intensity scale ranging from 0 (“no pain”) to 10
(“as much pain as possible or intolerable pain”). A change of 2 points or more was identified
as the minimal clinically important difference (MCID) in participants with chronic neck
pain [33].
(2) Neck disability index (NDI)
The NDI is a patient-completed, condition-specific functional status questionnaire
with 10 items. The total score of this questionnaire ranges between 0 and 50 points, with
higher scores indicating higher levels of disability, which is expressed as a raw score with a
maximum score of 50. The MCID of the NDI is 5.5 [20,33,34].
(3) Active cervical range of motion (CROM)
Active CROM was measured in a sitting position using a CROM goniometer (CROM
Deluxe model; Performance Attainment Associates, Roseville, MN, USA). The CROM
allows measurement of ROM in three planes (flexion/ extension, lateral flexion, and
rotation about gravity). Participants sat upright and were asked to move their necks in
each direction 3 times. Documentation of cervical ROM was expressed in the form of full
range, a total value for the sagittal (flexion and extension), frontal (lateral flexion right and
left), or transverse plane (rotation right and left), in the form of 3 measurements [35,36].
(4) Three-dimensional posture parameters of the head in relation to the thoracic region
A 3D postural assessment, known as the Global Posture System (GPS) 600, (Chinesport,
Udine, Italy), was used to examine the postural displacement variables [37–39]. This device
was used per the manufacturer’s instructions [37]. The device has a unit for podoscopic
analysis, a unit for postural analysis, and a stability measuring platform, and it comes with

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an image acquisition system and custom software. The camera of the image acquisition
system was positioned 107 cm from the ground and 190 cm from the subject. The reliability
and validity of this device have been verified previously where measurements demon-
strated excellent within-rater reliability (ICC = 0.89) and standard error of measurement
(SEM) = 1.5 degrees with a minimum detectable change (MDC) = 1.9 degrees; while inter-
rater reliability is good to excellent (ICC= 0.7) [40,41]. We analyzed the posture of the head
in relation to the thoracic region in terms of translations and rotations.

2.4.3. Assessment Procedures

A. Preparation of patients:
The patients were asked to wear tight-fitting clothes to allow the examiners to find
various anatomical sites. The examiners placed 13 markers on each patient before taking
the four photographs.
B. Marker placement:
Antero-posterior and lateral view marker locations are shown in Figure 1. The points
over which the markers were fixed were well-cleaned with alcohol to remove any moisture
and to ensure good fixation. Four photographs or four views were obtained for every
patient, one anterior and one posterior view and two lateral (right, Rt, and left, Lt) views.

Figure 1. The photographs taken using the Global Posture System (GPS). (A) Anterior and posterior
views. (B) Sagittal plane or lateral views. The six reflective markers used in the analysis are:
acromion, anterior superior iliac spine, posterior superior iliac spine, glabella, tragus, C7, and middle
sternal notch.

C. Starting position of the patients:

For the photographs, patients were instructed to stand on the lux postural analyzer
part of the GPS, to take a deep breath 3–5 times for full relaxation, to nod their head up
and down twice with their eyes closed, and to assume what they felt to be a neutral body
posture then participants’ eyes were opened, and they remained still, without any motion,
during this stance. Four digital photographs were taken using a computer mouse. The set
of photographs was processed through secure software analysis using GPS.

2.4.4. Measured Items (the Postural Parameters) of the Head Region in Relation to the
Thoracic Region
A right-handed Cartesian coordinate system with x-axis positive to the left, y-axis
positive vertically, and z-axis positive to the anterior was used to describe postures of the
head as translation displacements in centimeters (Tx, Ty, and Tz) along these axes and,
in addition, as rotation displacements (Rx, Ry, and Rz) in degrees from a normal upright
stance. Vertical translations (Ty), which would require radiographic analysis of hypo- or
hyper-lordosis, were not calculated in the present study as is shown in Figure 2 [23].

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Rx1 (pre) Ry1 (pre)

Rz1 (pre) Tx1 (pre)

Tz1 (pre)

Figure 2. Three-dimensional postural parameters of the head region in relation to the thoracic region.
Postural rotations (Rx, Ry, Rz). Postural translations (Tx, Tz).

2.4.5. Postural Translations of the Head in Relation to the Thoracic Region

Tx (Rt. or Lt. side shifting or lateral translation), is the measure of the horizontal
distance from the vertical line passing through the middle sternal notch to the vertical line
passing through the nose [16].
Tz (anterior head translation), is the measure of the horizontal distance from the
vertical line crossing the middle acromion process to the vertical line crossing the tragus of
the ear [22].

2.4.6. Postural Rotations of the Head in Relation to the Thoracic Region

Rx (flexion or extension position of upper cervical), is the measurement of the angle
between the tragus of the ear, the canthus of the eye, and the horizontal line [10].
Ry (Rt. or Lt. rotation), is the measurement of the angle between the glabella of the
forehead or tip of the nose, the middle point of the chin, and the vertical line [23].
Rz (Rt. or Lt. side bending), is the measurement of the angle between the inferior
margins of the right and the left ear and the horizontal line [10].

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2.5. Interventions
Both groups received conventional or local treatment consisting of a moist hot pack,
soft tissue mobilization, manual therapy, and therapeutic exercises [42–45] (Table 1). Only
the study group received 3D PCO to perform the mirror image therapy (reverse posture
training) for 20–30 min while the patient was walking on a motorized treadmill 2–3 times
per week for 10 weeks. The CONSORT flow chart diagram for this trial is presented in
Figure 3.

54 participants responded to

advertisements at clinics.

Assessed for eligibility according to

Excluded, n = 30
inclusion and exclusion criteria.
• No time, n = 11
•NPRS ! 3, NDI ! 5, n = 9.
Recruitment

•Did not match with criteria of

3D posture analysis,
n = 10.

Randomization
Allocation

Study group (n = 12) received Conventional TTT + 3D

Control group (n = 12) received conventional
PCO to make mirror image therapy (reverse posture
treatment consisting of moist hot pack, soft tissue
training) for 20–30 min during the patient walking on
mobilization, manual therapy, therapeutic
motorized treadmill, 30 times/10 weeks.
exercise. 30 times/10 weeks.

Drop out before finishing treatment and reassessment Drop out before finishing treatment and
reassessment due to travel to other city, n = 1.
due to travel to other city, n = 2.

Feasibility outcomes assessment Reassessment of Feasibility outcomes assessment. Reassessment of

NPRS + NDI + active cervical ROM + 3D postural NPRS + NDI +active cervical ROM + 3D postural

analysis using GPS, n = 10. analysis using GPS without using PCO, n = 11.

Analysed n = 10 Analysed n = 11

Figure 3. The CONSORT flow chart diagram for the trial.

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Table 1. Both the study and control groups received conventional or local treatment consisting of a
moist hot pack, soft tissue mobilization, manual therapy, and therapeutic exercises. Description of
this conventional treatment, exercise prescription, and progression are presented herein. Participants
in both groups attended 30 physical therapy treatment sessions over a 10-week period at 3 sessions
per week. See methods section for complete details of progressions.

Conventional Treatment Description

Applied to the area of pain at neck region muscles, such as the upper part of the trapezius, levator
Moist hot pack
scapulae, splenius capitis, and cervicis muscles, for 15 min.
Deep stroking massage performed along the entire length of the taut band within the painful or
Soft tissue mobilization
tight muscles.
Low-velocity passive mobilization techniques to the symptomatic cervical segments as determined
by the physiotherapist’s clinical examination. Physiotherapists could be able to select from what
Cervical mobilization
were termed passive accessory and physiological movement techniques as believed appropriate to
the individual participant based on the initial and progressive reassessments.
Level 1 Re-education of CCF movement pattern
1. Supine, knees bent
-Gentle and controlled nodding action facilitated with eye movement 10 reps
Holding.
2. Supine, knees bent
-Repeated and sustained CCF 10 s holds × 10 reps
Level 2 Interaction between the deep/superficial cervical flexors
Therapeutic exercises 1. Sitting
Cervical flexors -Controlled head movement through range of extension and return to neutral 10 reps
Co-contraction of the deep cervical flexors/extensors.
Level 3 Strength/endurance of the cervical flexors
1. Sitting
-Isometric CCF in a range of cervical extension 10 s holds × 10 reps
-Lifting the head off the wall (with the chair up to 30 cm away from the wall) 10 s holds × 10 reps
2. Supine
-Lifting the head off a pillow (2 or 1 then 0 pillows as per participant’s capacity) 10 s holds × 10 reps.
Level 1 Re-education of extension movement pattern
1. Prone on elbows/four-point kneeling positions
-Cranio cervical extension 3 sets of 5 reps.
-Cranio cervical rotation (<45◦ ) 3 sets of 5 reps.
-Cervical extension while keeping the cranio cervical region in a neutral position 3 sets of 5 reps.
Cervical extensors Level 2 Co-contraction of the deep cervical flexors/extensors
1. Sitting
-Isometric cervical rotation facilitated with eye movement (left/right sides) 5 s holds × 5 reps.
Level 3 Strength/endurance of the cervical extensors
1. Prone on elbows/four-point kneeling positions
-Isometric hold in range of cervical extension 10 s holds × 10 reps.
Level 1-Re-education of scapular movement control
Cervico scapular muscle control
1. Sitting
-Arm movement without load (external rotation/abduction/flexion < 30◦ ) 10 reps
-Arm movement without load throughout range 10 reps
2. Prone on elbows/four-point kneeling position
-Thoracic lift (serratus anterior) and isometric hold 5 s holds × 5 reps.
Cervico Scapular control
Level 2 Strength/endurance of cervico scapular muscles
1. Sitting
-Arm movement with load using Thera-band (external rotation/abduction/flexion < 30◦ ) 10 reps.
-Arm movement with load throughout the range 10 reps.
2. Prone
-Lift the shoulder off the bed and hold without arm load 10 s holds × 10 reps.
-Lift the shoulder off the bed and hold with arm load using Thera-band 10 s holds × 10 reps.

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Table 1. Cont.

Conventional Treatment Description

Level 1 Correction of spinal posture
Sitting
-Active upright sitting initiated with lumbo-pelvic movement 10 s holds × 10 reps
Level 2 Correction of spinal posture and scapular orientation
Sitting
-Actively positioning the scapular in a neutral posture while maintaining spinal posture
Postural correction 10 s holds × 10 reps
Level 3 Spinal and scapular correction plus occipital lift
Sitting
-Actively lengthen the back of the neck while maintaining spinal and scapular posture
10 s holds × 10 reps.
Standing on wall
Actively extend spine then chin in cervical with squeezing abdomen 10 s holds × 10 reps.
CCF: craniocervical flexion; reps: repetitions.

Study Group 3D PCO Performed the Mirror Image® Therapy (Reverse Posture Training)
While the Patient Was Walking on Motorized Treadmill
Mirror image therapy (reverse posture training) was delivered via the use of the ad-
justable PCO (patent number CN201921929736.1), as shown in Figure 4. The PCO was
applied, to reverse the abnormal posture according to the 3D posture analysis data, while
the patient was walking at approximately 2–3 miles per hour on a standard motorized
treadmill for 20–30 min per session. To facilitate tissue remodeling and to stretch ligamen-
tous tissues reverse posture training was applied in the mirror image traction or therapeutic
position; an example of participant data is shown in Table 2. Then, walking training using
the treadmill was performed during which the participant’s mirror image traction could
be held by the adjustable PCO based on mirror image therapy, which has been previously
used in other studies based on Harrison et al., 2004 [16,17,46]. The rationale for walking on
the treadmill while maintaining a patient’s mirror image position is based on the concept
of neuromuscular retraining of motor patterns that have developed over time in both
static and dynamic posture tasks and is based on the earlier randomized trial by Diab and
Moustafa [17]. This program was repeated 2–3 times/week for 10 weeks, as in Figure 5 (as
shown in the Supplementary Video File).
Table 2. Example of 3D posture analysis data and mirror image therapy (reverse posture training)
using the posture corrective orthotic PCO.

3D Posture Analysis of Head in Relation to Thoracic Reverse 3D Posture Data by PCO (Mirror Image Therapy)
1. Rx (extension position of the head) = 25◦ − 18◦ = 7◦ extension. 7◦ flexion of the head.
2. Ry (right or left rotation of the head) = 6◦ left rotation. 6◦ right rotation of the head.
3. Tz (anterior head translation = 5.8 cm anterior head translation. 5.8 cm posterior head translation.
4. Rz (right or left side bending) = 5◦ right side bending. 5◦ left side bending.
5. Tx (side shifting of the head = 1.4 cm right side shifting. 1.4 cm left side shifting.

Participants in both groups attended 30 physical therapy treatment sessions over a

10-week period at 2–3 sessions per week. Short-term follow-up evaluations were performed
after 10 weeks of interventions. To minimize therapist variation and to increase consistency,
the same physiotherapist independently delivered the entire intervention program for every
participant. Every physiotherapist had 10 years of experience and received training for the
application of the specific interventions for one week before starting the study. Participants
in both groups were advised to perform all therapeutic exercises once daily as their home
routine during non-treatment days and to follow the posture correction advice. Record
sheets were collected every week and were subsequently analyzed to calculate the mean

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exercise frequency per week and the mean exercise time per day. To monitor the exercise
times and the number of sets performed during the study accurately, videos of the exercises,
photos of postural correction, and a record sheet were distributed to the participants.

Figure 4. Posture corrective orthotic (PCO) demonstrating the availability to move in different
directions and lock the head in its opposition position. Top row: lateral translation of the head left
and right (Tx). Second row: anterior and posterior translation of the head (Tz). Third row: rotation of
the head about vertical gravity left and right (Ry). Fourth row: side bending of the head left and right
(Rz). Bottom row: extension and flexion of the head (Rx). See Figure 5 for a sample patient setup.

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Figure 5. Three-dimensional PCO to perform the mirror image therapy (reverse posture training)
while the patient was walking on motorized treadmill.

2.6. Statistical Analysis

Primary outcome measures and their results described in our study protocol [47] are
discussed descriptively in Table 3. To estimate the sample size for a future full-scale RCT,
between-group effect sizes and 95% confidence intervals (CIs) with Hedges’ correction
were calculated for the change in the secondary outcomes of NPRS, NDI, active cervical
ROM, and 3D posture parameters. The mean ± standard deviation (SD) value for each
of the secondary outcomes was used in the calculation of the effect size. The estimated
sample size was then determined using the between-group effect size with a minimum of
80% power (α = 0.01 or 3D posture parameters and α = 0.05 for other secondary outcomes)
using G power software. The sample size will be increased by 20% to allow for an estimated
dropout rate in the future RCT. Statistical methods for the secondary outcome measures
were evaluated by comparing the change within groups (from baseline to post-treatment)
and then estimating the within-group effect size. Complete analyses were conducted
to include outcomes from all participants who completed baseline and post-treatment
evaluations as recommended in CONSORT guidelines [48]. The between-group difference
in change scores for each outcome measure from baseline to post-treatment was calculated
as the mean and 95% CI. All statistical analyses were performed with SPSS Version 2.2
software (IBM Corporation, Armonk, NY, USA). Correlations (Pearson’s r) were used to
examine the relationships between the 3D postural parameters and all measured outcomes.

Table 3. Results of primary aim (feasibility).

Primary Aim/Criteria Description

Integrity of the study protocol With 45% of interested participants being eligible.
• Recruitment: minimum requirement of 80% of eligible 100% of eligible participants enrolled in the study. Inclusion criteria of the study
participants entering study. protocol appeared acceptable.
The eligibility criteria were followed with another published paper [19], and our
Validity of eligibility criteria
protocol that was published previously [47].
During the post-study interview, physical therapists said that one-week training
Understanding and integrity of intervention for treating before study was appropriate and enough, continuous communication with the
physical therapists study authors was essential to ensure that the protocol was followed
throughout the study.
During the post-study interview, participants upraised the concern that with one
treating physical therapist, appointments availability were limited. They felt that
Convenience of intervention for participants
more availability of appointments would enhance recruitment and retention or
more than treating physical therapist for every participant.

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Table 3. Cont.

Primary Aim/Criteria Description

During the post-study interview, participants in both groups said that they
believed the intervention was valuable, and they would participate in the study
Integrity and suitability of intervention to participants again. Only one issue was that the treatment period was too long and, hope to
reduce treatment period of intervention in the future, and none expressed offense
about being randomized to the control intervention.
During the post-study interview, while participants stated that a large time
commitment was required to participate in the study, they all acknowledged that
Feasibility of study time requirement and study facilities this was necessary for improvement. However, they advised us to reduce
for participants treatment sessions to less than 30 times although ten weeks was good time to
make improvement in posture deviations. All participants felt that the services in
which the interventions were delivered were appropriate.
Fifty-four people responded to recruitment at rehabilitation clinic over a 9-months
Recruitment and retention procedures inclusion period. Of these, 45% fulfilled inclusion criteria, and all were included in
• Goals for minimum requirement for adequate recruitment the study at rehabilitation clinic.
and retention: at least 80% of participants attended 75% of Of the 24 participants, 21 attended all treatment sessions and 3 lost before finishing
appointments and completed 75% of the prescribed exercises treatment. No adverse events were recorded. Exercise intervention compliance
was measured using either record sheet diaries or via WeChat application.
At the end of the study, all 21 participants who finished the study completed
Testing of outcome measurement collection
patient-reported outcome questionnaires, neck ROM and 3D posture parameters.
• Determined by completeness of outcome data collected, and
The blinded outcome assessor, with no missing data, collected it for
through post-study interview
all participants.
Suitability of randomization procedure and methods used to
ensure blinding The randomization procedure was appropriate, with the treating physical
• Determined during post-study interviews of treating therapist informed of group allocation but outcome measurement assessor was not
physical therapist, blinded outcome assessor. aware of group allocation of any participants.
Selection of the most appropriate primary outcome measure All participants knew group allocation because of heterogeneity of interventions.
for a full-scale RCT NDI (0.79), as a measure of neck disability and quality of life, and 3D posture
Determined based on outcome measure with largest between parameters of head in relation to thoracic (Tx, Tz, Rx, Rz, Ry) were selected.
group effect size
A sample size of 42 participants (21 in each group) provides a minimum of 80%
Estimation of required sample size for a fully powered study power (α = 0.05) and is required for an effect size of 0.79. To account for an
• Based on NDI estimated 20% dropout, the recommended sample size is 50 participants (25 in
each group).
NDI: neck disability index; ROM: range of motion; 3D: three-dimensional.

3. Results
Of 54 people who responded to advertisements in orthopedic and rehabilitation
department clinics and were interested in participating in the study, 11 people did not
have time to complete the intervention, 9 people had NPRS less than 3 and NDI less than
5, and 10 people did not meet the inclusion criteria of 3D posture measurements of the
head in relation to the thoracic region. In the end, 30 people were excluded and 24 people
were included (45% who fulfilled inclusion criteria and 100% of included participants
enrolled in the study), as shown in Figure 3. Those 24 participants fulfilled all procedures
of assessment and interventions, but 3 (12.5%) participants were lost and did not make
the final assessment (2 from the control group and 1 from the study group). Complete
demographic characteristic data of participants are shown in Table 4.
The results of the primary outcome aspects related to feasibility are provided in
Table 3. Using the extension of the CONSORT statement for pilot and feasibility studies
when developing the protocol our findings were informed by our previously published
protocol. The recruitment into our study was achieved in an acceptable period, and less
than 15% of participants were lost to follow-up before the final assessment because they
had to travel to other cities and did not have time to continue the treatment and assessment.
We used complete case analyses, where 12.5 % (3 of 24) of participants were excluded
because of missing data.

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Table 4. Demographic characteristic data of participants.

Study Group (n = 12) Control Group (n = 12) p-Value

Age (y) mean ± SD 27.4 ± 5.5 27.2 ± 4.7 0.7
Weight (kg) mean ± SD 64.58 ± 6.9 67.2 ± 5.8 0.3
Height (m) mean ± SD 1.65 ± 0.5 1.67 ± 0.6 0.6
BMI (kg/m2 ), mean ± SD 23.5 ± 1.2 24.2 ± 0.97 0.2
Male, n (%) 8 (66.7%) 7 (58%) 0.5
Female, n (%) 4 (33.3%) 5 (42%) 0.5
Participants Employment
University student, n (%) 7 (58%) 6 (50%) 0.6
Desk office worker n (%) 4 (33.3%) 4 (33.3%) 0.5
House wife, n (%) 1 (8.3%) 2 (16.7%) 0.6
Married, n (%) 4 (33.3%) 3 (25%) 0.7
Duration of Pain, n (%)
3–24 months 8 (66.7%) 9 (75%) 0.6
>24 months 4 (33.3%) 3 (25%) 0.7
Current use of Medications, n (%)
Yes 2 3 0.6
No 10 9 0.7
Referred pain, n (%) 6 (50%) 7 (58%) 0.5
Current smoker, n (%) 2 (16.7%) 3 (25%) 0.6
Mean ± SD: standard deviation; BMI: body mass index.

Table 5 shows the within-group change in each of the secondary outcome measures
for each group. In general, larger improvements and greater effect sizes were found in the
study group for pain, disability, postural measures, and cervical spine range of motion.
Between-group differences in change scores, effect size, and estimated sample size for
each of the secondary outcome measures of NDI, NPRS, and range of motion are shown
in Table 6. While Table 7 presents the between-group differences in change scores, effect
size, and estimated sample size for each of the secondary outcome measures of 3D posture
displacements of Tx, Tz, Rx, Ry, and Rz. In general, larger improvements and greater
effect sizes were found in the study group for pain, disability, postural measures, and
cervical spine range of motion in Tables 6 and 7. Sample size estimates for the full-scale
RCT indicated that a minimum of 14 participants (ROM for flexion and extension) and
a maximum of 80 participants (ROM y-axis rotation) would be needed for full statistical
evaluation. A full-scale RCT using our multimodal program for participants with CNSNP
related to poor posture would require a sample of 42 participants (without calculating any
dropout) to demonstrate a clinically meaningful functional improvement based on the NDI.
Table 6.
We found a moderately positive correlation between pre- and post-treatment changes
in 3D postural parameters and pre- and post-treatment changes in pain and NDI, indicating
that as posture displacement decreased in our population, so did pain intensity and NDI
scores. However, as shown in Table 8, we discovered a moderately negative correlation be-
tween cervical ROM values and pre- and post-treatment changes in 3D postural parameters.

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Table 5. Within-group change in secondary outcome measures for each group. Postural translations
(Tx and Tz) are measured in centimeters, postural rotations (Rx, Ry, Rz), and ranges of motion (ROM)
are measured in degrees. The mean difference (MD) is the difference between the baseline and
after-treatment values. A negative value for the change (MD) in range of motion indicates an increase
in the overall motion for the variable.

Baseline Post Intervention MD † ES

Mean ± SD Mean ± SD (p Value 95% CI) (d)
NDI (0–50) 9.1 ± 4.3
12.42 ± 4.54 3.33 ± 2.42 2.5
Study G <0.001 * (6.4, 11.8)
7 ± 1.13
Control G 12.41 ± 3.02 5.41 ± 2.35 2.5
<0.001 * (6.4, 7.7)
NPRS (0–10) 3.2 ± 1.26
5 ± 1.4 1.8 ± 1.03 2.6
Study G <0.001 * (2.4, 3.9)
2.6 ± 0.4
Control G 4.91 ± 1.2 2.29 ± 0.87 2.49
<0.001 * (2.4, 2.9)
0.56 ± 0.37
Tx Study G 0.97 ± 0.4 0.41 ± 0.13 1.87
<0.001 * (0.3, 0.8)
0.075 ± 0.05
Tx Control G 0.75 ± 0.35 0.68 ± 0.31 0.2
0.29 (0.04, 0.1)
1.6 ± 1.05
Tz Study G 3 ± 1.3 1.34 ± 1.1 1.2
<0.001 * (0.9, 2.4)
0.24 ± 0.28
Tz Control G 3.1 ± 1.4 2.85 ± 1.6 0.15
0.23(0.06, 0.4)
5.4 ± 3.2
Rx Study G 24.8 ± 4.17 19.41 ± 2.54 1.56
<0.001 * (3.4, 7.45)
1.5 ± 2.3
Control G 23.8 ± 3.95 22.3 ± 3.98 0.38
0.013 (0.03, 2.96)
2 ± 1.88
Ry Study G 3.5 ± 1.6 1.58 ± 0.67 1.35
<0.001 * (0.7, 3.1)
0.5 ± 0.52
Ry Control G 3 ± 1.3 2.33 ± 1.4 0.29
0.16 (0.2, 0.8)
1.83 ± 1.8
Rz Study G 3.3 ± 1.5 1.5 ± 0.79 1.34
<0.001 * (0.7, 2.97)
0.5 ± 0.52
Rz Control G 3 ± 1.4 2.33 ± 1.4 0.29
0.2 (0.2, 0.8)
ROM flex and extension −21 ± 0.18
87.1 ± 4.18 108.1 ± 4 5
Study G <0.001 * (−21.3, −20.7)
−13.9 ± 0.37
Control G 86.7 ± 4.37 100.6 ± 4 3.3
<0.001 * (−14.4, −13.5)
ROM lateral flexion −14.5 ± 0.5
65.75 ± 4.5 80.25 ± 4 3.4
Study G <0.001 * (−14.7, −14.3)
−9.5 ± 0.4
Control G 63.91 ± 4.6 73.41 ± 4.2 2.1
<0.001 * (−9.8, −9.4)
ROM rotation −17 ± 0.33
101.8 ± 2.33 118.8 ± 2 7.8
Study G <0.001 * (−17.1, −16.96)
−15.9 ± 0.02
Control G 101.58 ± 2.2 117.48 ± 2 7.5
<0.001 * (−16, −15.8)
Mean. MD, mean difference NDI, neck disability index. NPRS, numeric pain rating scale. ROM, range of motion.
Flex. flexion. ES (d), effect size (Cohen’s d), Tx, side shifting of head. Tz, Ant. head translation. Rx, upper
extension of head. Ry, R.t or l.t rotation of head. Rz, side bending R.t or l.t of head. † Values in parentheses are
95% confidence interval. G, group. Sig.; significant, 001, Sig; 0.01. * Significant for TZ, TX, Rx, Ry, Rz. Sig; 0.05,
* significant for all other outcomes.

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Table 6. Between-group differences in change scores, effect size, and estimated sample size for each
of the secondary outcome measures with significance level of 0.05. The mean difference (MD) is the
difference between the two groups’ change score values. A negative value for the change (MD) in
range of motion indicates an increase in the overall motion for the variable for that group whereas
the difference between the group is a positive number indicating greater improvement for the study
group. Ranges of motion (ROM) are measured in degrees.

Study Group Change Score * Control Group Change Score * MD † ES Estimated Total Sample Size
(Baseline to Posttreatment) (Baseline to Posttreatment) (p Value 95% CI) (d) for Outcome Measure, n ‡
2.08
NDI (0–50) 9.1 ± 4.3 7 ± 1.13 0.79 42
<0.001 * (4.11, 0.06)
0.458
NPRS (0–10) 3.2 ± 1.26 2.6 ± 0.4 0.58 76
<0.001 * (1.26, 0.35)
7.42
ROM flex and exten. −21 ± 0.18 −13.9 ± 0.37 1.78 14
<0.001 * (3.79, 11.1)
6.8
ROM lateral flexion −14.5 ± 0.5 −9.5 ± 0.4 1.26 22
<0.001 * (2.97, 10.7)
1.35
ROM rotation −17 ± 0.33 −15.9 ± 0.02 0.56 80
<0.001 * (−0.49, 3.2)
NDI, neck disability index. NPRS, numeric pain rating scale. ROM, range of motion. Flex and exten., flexion and
extension. MD, mean difference. * Values are mean ± SD. † Values in parentheses are 95% confidence interval.
‡ Estimated sample size determined using Student t test sample size calculation, without adjusting for anticipated

dropouts and losses to follow-up (α = 0.05, β = 0.80). Sig; 0.05. ES (d), effect size (Cohen’s d).

Table 7. Between-group differences in change scores, effect size, and estimated sample size for 3D
posture parameters of head related to thoracic with significance level 0.01. Postural translations (Tx
and Tz) are measured in centimeters and postural rotations (Rx, Ry, Rz) are measured in degrees.

Study Group Control Group MD † ES Estimated Total Sample Size for

Change Score * Change Score * (p Value 95% CI) (d) Outcome Measure, n ‡
.48
Tx (side shifting of head) 0.56 ± 0.37 0.07 ± 0.04 1.70 18
<0.001 * (−0.48, −0.05)
1.36
Tz (Ant. H. Translation) 1.6 ± 1.05 0.24 ± 0.28 1.1 38
<0.001 * (−2.6, −0.28)
3.9
Rx (upper extension of head) 5.4 ± 3.2 1.5 ± 2.3 1.12 36
<0.001 * (−5.75, −0.09)
1.5
Ry (rot. R.t or l.t of head) 2 ± 1.88 0.5 ± 0.52 0.96 48
<0.001 * (−1.72, 0.22)
1.33
Rz (side bending R.t or l.t of head) 1.83 ± 1.8 0.5 ± 0.52 0.90 52
<0.001 * (−1.8, 0.15)

H, head. rot., rotation. * Values are mean ± SD. Values in parentheses are 95% confidence interval. ‡ Estimated
†

sample size determined using Student t test sample size calculation, without adjusting for anticipated dropouts
and losses to follow-up (α = 0.01, β = 0.80). Sig; 0.01. ES (d), Effect size (Cohen’s d).

Table 8. Correlations (Pearson’s r) were used to examine the relationships between the 3D postural
parameters and all measured outcomes for the entire sample. * Indicates a statistically significant
difference at p < 0.001.

Change in Changes in Changes in ROM Flex Changes in ROM Changes in ROM

Neck Pain NDI and Exten Lateral Flexion Rotation
0.5 −0.48 −0.51 −0.41
Change in Tx (side shifting of head) 0.5
<0.001 * <0.001 * <0.001 * 0.01
0.6 0.31 −0.53 −0.43 −0.33
Change in Tz (Ant. H. Translation)
<0.001 * 0.06 <0.001 * 0.04 0.05
0.3 0.49 −0.51 −0.32 −0.3
Change in Rx (upper extension of head)
0.06 <0.001 * <0.001 * 0.05 0.06
0.5 0.62 −0.4 −0.56 −0.71
Change in Ry (rot. R.t or l.t of head)
<0.001 * <0.001 * 0.01 <0.001 * <0.001 *
0.4 0.46 −0.3 −0.51 −0.54
Change in Rz (side bending R.t or l.t of head)
0.01 <0.001 * 0.06 <0.001 * <0.001 *

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4. Discussion
Our promising results suggest that it is feasible to conduct a full-scale RCT using a 3D
PCO to perform mirror image therapy (reverse posture training) while a patient is walking
on a motorized treadmill. Based on our data, a full-scale RCT using our multimodal
program for participants with neck pain related to poor posture or postural neck pain
would require a sample of 42 participants (without calculating any dropout) to demonstrate
a clinically meaningful functional improvement based on the NDI. While feasible, our
results also suggest that some modifications to the protocol may enhance participant
enrolment, including access to the intervention and the effectiveness of various aspects
of the intervention in future studies. Furthermore, since study participants indicated that
the treatment sessions were quite lengthy, a reduction in treatment time is needed in a
future full-scale trial. This can be accomplished by reducing the number of interventions
(hot packs and one of the mobilization procedures) and reducing the walking time on the
treadmill to 15–20 min instead of 20–30 min.
In our pilot study, 54 people responded to advertisements, 24 (45%) of whom were
eligible. Therefore, at least 93 potential participants would be required to respond to adver-
tisements to obtain a sample of 42 participants. This information will assist in planning the
extent of the intervention, timelines for recruitment, and budgets for future studies.
The diagnosis was based on physical examination, including history, demographic
variables, the mode of onset, duration of symptoms, nature, and location of symptoms, as
well as questions regarding aggravating and relieving factors, such as posture modifications
and change positions and any prior history of neck pain (3). The assessment also depended
on pain level, neck disability, 3D posture analysis of the head in relation to the thoracic
region, and active cervical range of motion. We subsequently used an X-ray to exclude
any specific cause of pain. Notably, a large number (30/54, 55%) of participants were
excluded; they had neck pain, but their NPRS was less than 3 and NDI was less than 5, and
posture modifications or poor posture were not the risk factor for the problem occurring.
Those symptoms were diagnosed as myofascial pain syndrome. Other participants had
NPRS and NDI and a score of more than 3 and 5, respectively, but did not match the 3D
posture analysis criteria; the cause of the problem was not due to posture modifications or
poor posture. We tried to include participants who had poor posture according to the 3D
analysis, and to modify poor posture, which affects participant symptoms and function;
ultimately, we attempted to include only participants with postural components to their
neck pain [10,13].
We included neck pain and a disability score from moderate to severe on the NPRS
and NDI. Most participants had a fixed position during smartphone use or in the workplace
for long periods or had a monotonous constrained vision-related task such as computer
programming. Only three participants were housewives using smartphones for extended
times in the flexed neck position; the other participants were university students and desk
office workers who were often using computers in a slumped seated position in FHP for a
prolonged time.
To the best of our knowledge, this intervention was the first to use a 3D PCO for
mirror image therapy (reverse posture training) of the cervical spine while the patient
is walking on a motorized treadmill and to utilize a supervised, tailored brace for each
participant according to 3D posture analysis, as well as functional walking training for at
least 20 min using the PCO as active not passive therapy. Within-group effect sizes for
improvement of 3D posture analysis data of the head, in relation to the thoracic region
(five posture variables, two translation displacements, and three rotational displacements),
in the study group were very large (1.19–1.87). Interestingly, the control group also had
small to medium gains in 3D posture analysis data (effect size, 0.15–0.38). Likely speaking,
the larger changes in the study groups’ postures are due to the targeted mirror image
therapy using the PCO with functional walking training on a treadmill. The training
was thus tailored according to each participant’s 3D analysis data. Because both groups
practiced a therapeutic exercise program as shown in Table 1, this might explain the posture

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improvement in some parameters (Rx, Ry, and Rz) of 3D posture analysis in the control
group. In addition, the study group reported large within-group improvements in pain,
function, and quality of life, but due to the limitation in the sample size, we can only infer
that this was due to the PCO training and postural correction.
Future fully powered RCTs should explore whether greater improvements in pain and
quality of life are associated with improvements in 3D posture parameters and whether
or not these continue to improve after follow-up for 3 to 6 months or longer. Our future
RCT will include these specifications, especially a follow-up period of 6 months (Clinical-
Trials.gov ID: NCT04263883), and will use a sham or a placebo brace for the control group.
In our pilot study, the effect size for between-group differences in change scores is
moderately large in the study group for all secondary outcomes, such as NDI, NPRS, and all
active neck ROM, as well as all parameters of 3D posture analysis. The changes visualized
on photographic measurements would be due to the application of traction forces to the
lateral cervical structures or the reverse posture traction (reverse posture training) on
3D planes. The muscles and ligamentous structures of the spine are viscoelastic. The
deformation of these structures is, mechanically, time-dependent and force-dependent [16].
When under loading, spinal ligaments complete a stress relaxation process in approximately
500 s (8.33 min). However, the intervertebral disc will continue to deform for 20 min to
60 min [16,49,50]. For this reason, we progressively increased the PCO therapy up to
20 min in the form of functional training, such as walking, to attain the maximum amount
of deformation to the paraspinal structures in a clinically efficient time.
The strengths of our study included using the extension of the CONSORT statement
for pilot and feasibility studies when developing the protocol [48,51]. In addition, our
findings were informed by our previously published protocol [47]. The recruitment into
our study was achieved in an acceptable period, and less than 15% of participants were lost
to follow-up before the final assessment because they had to travel to other cities and did
not have time to continue the treatment and assessment. We used complete case analyses,
where 12.5% (3 of 24) of participants were excluded because of missing data. Despite
options for the statistical imputation of missing data, minimizing the dropout rate should
be a priority in our future studies.

5. Limitations
The study had some potential limitations, each of which points toward directions for
future study. The first limitation of our study was the lack of blinding of participants and
physiotherapists because of the nature and difference of the interventions. It was difficult to
blind participants and healthcare providers. However, the investigator, outcome assessor,
and data analyst were blinded to the participant allocation group. We can overcome this
issue in future studies by adding a placebo-treated group for mirror image traction using
another orthotic intervention, such as another cervicothoracic brace without adjustment
according to 3D posture analysis. Additionally, our study results are limited to the outcome
measurements chosen to evaluate CNSNP. It is possible that using different outcome
measures of neck pain, such as muscle endurance, motor control, and proprioceptive tasks,
would produce different findings between the intervention and control groups. Third, the
assessment of psychosocial models, such as depression and fearful avoidance of movement,
were not included in our pilot, and we will assess them in a future RCT. Fourth, our study
did not include a true natural history group with chronic neck pain and participants must
not have had physical therapy treatment in the previous 6 months, but it was unknown
which other treatment they might have received prior to the previous 6 months.
The last limitation was the small sample size, which weakens any strong interpretation
regarding the effectiveness of our intervention. We could not solve all these limitations
at the same time in one study because the PCO used in the study is a new device for
therapeutic use. Instead, we focused on the design of a new postural mirror image brace
and first assess its feasibility, the pilot study outcomes, and the secondary assessment of its

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direct effect on 3D posture parameters and its indirect effect on neck pain, disability, and
active neck ROM.

6. Conclusions
It was demonstrated that a full-scale RCT of a 3D PCO to perform mirror image
therapy (reverse posture training) is feasible. Adding a 3D PCO to a multimodal program
positively affected neck pain management outcomes by reducing neck pain, improving
neck function, and increasing active ROM, which was likely due to improved 3D posture
alignment of the head. Adequately powered and improved studies are needed to confirm
or refute this association.

Supplementary Materials: The following supporting information can be downloaded at: https:
//www.mdpi.com/article/10.3390/jcm11237028/s1, Video S1: Mirror image postural neuromuscular
retraining of motor patterns.
Author Contributions: A.S.A.Y., I.M.M., A.M.E.M., X.H. and D.E.H. conceived the research idea and
participated in its design; A.S.A.Y., I.M.M., A.M.E.M. and X.H. contributed to the statistical analysis;
A.S.A.Y., I.M.M., A.M.E.M. and X.H. participated in the data collection, A.S.A.Y., I.M.M., A.M.E.M.,
D.E.H. and P.A.O. contributed to the interpretation of the results and wrote the original and final
drafts. All authors have read and agreed to the published version of the manuscript.
Funding: This research received no external funding.
Institutional Review Board Statement: The study was conducted in accordance with the Declaration
of Helsinki and approved by the Institutional Review Board from the Ethical Committee of Tongji
Hospital, Tongji Medical College, Huazhong University of Science and Technology (HUST), Wuhan,
China (certificate of approval number TJ-IRB20170703) approval date 3 July 2017. All participants
provided written informed consent before the beginning of the study.
Informed Consent Statement: Written informed consent was obtained from the person depicted
in Figures 1, 2 and 5, and the supplementary video for the publication of picture and video in the
manuscript. A copy of the written consent is available for review by the Editor-in-Chief of this journal.
Data Availability Statement: The datasets analyzed in the current study are available from the
corresponding author upon reasonable request.
Conflicts of Interest: P.A.O. is a paid consultant for CBP NonProfit, Inc. D.E.H. teaches rehabilitation
methods and sells products to physicians for patient care similar to that used in this manuscript. All
the other authors declare that they have no competing interests.
Trial Registration: ClinicalTrials.gov Identifier: NCT03331120. Registered 6 November 2017, https:
//clinicaltrials.gov/ct2/show/NCT03331120.

Abbreviations
CNSNP: chronic nonspecific neck pain; 3D: three-dimensional; PCO: posture corrective orthotic;
ROM: range of motion; NPRS: numeric pain rating scale; NDI: neck disability index; GPS: global
posture system; RCT: randomized control trial; Tx: r.t or l.t side shifting of head; Tz: anterior head
translation; Rx: extension of upper cervical; Ry: r.t or l.t rot. of head; Rz: R.t or l.t side bending of
head; Ant.: anterior; Rot.: rotation; FHP: forward head posture; SD: standard deviation; CI: confi-
dence interval.

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Clinical Medicine

Article
Reduction of Thoracic Hyper-Kyphosis Improves Short and
Long Term Outcomes in Patients with Chronic Nonspecific
Neck Pain: A Randomized Controlled Trial
Ibrahim Moustafa Moustafa 1,2 , Tamer Mohamed Shousha 1,2 , Lori M. Walton 1 , Veena Raigangar 1
and Deed E. Harrison 3, *

1 Department of Physiotherapy, College of Health Sciences, University of Sharjah,

Sharjah P.O. Box 27272, United Arab Emirates
2 Faculty of Physical Therapy, Cairo University, Giza 12511, Egypt
3 Private Practice and CBP Non-Profit, Inc., Eagle, ID 83616, USA
* Correspondence: [email protected]

Abstract: This study investigates thoracic hyper kyphosis (THK) rehabilitation using the Denneroll™
thoracic traction orthosis (DTTO). Eighty participants, with chronic non-specific neck pain (CNSNP)
and THK were randomly assigned to the control or intervention group (IG). Both groups received
the multimodal program; IG received the DTTO. Outcomes included formetric thoracic kyphotic
angle ICT—ITL, neck pain and disability (NDI), head repositioning accuracy (HRA), smooth pursuit
neck torsion test (SPNT) and overall stability index (OSI). Measures were assessed at baseline, after
30 treatment sessions over the course of 10 weeks, and 1-year after cessation of treatment. After
10 weeks, the IG improved more in neck pain intensity (p < 0.0001) and NDI (p < 0.001). No differences
were found for SPNT (p = 0.48) and left-sided HRA (p = 0.3). IG improved greater for OSI (p = 0.047)
and right sided HRA (p = 0.02). Only the IG improved in THK (p < 0.001). At 1-year follow-up, a
Citation: Moustafa, I.M.; Shousha, regression back to baseline values for the control group was found for pain and disability such that all
T.M.; Walton, L.M.; Raigangar, V.; outcomes favored improvement in the IG receiving the DTTO; all outcomes (p < 0.001). The addition
Harrison, D.E. Reduction of Thoracic of the DTTO to a multimodal program positively affected CNSNP outcomes at both the short and
Hyper-Kyphosis Improves Short and 1-year follow-up.
Long Term Outcomes in Patients
with Chronic Nonspecific Neck Pain: Keywords: neck pain; thoracic kyphosis; randomized trial; postural kyphosis; sensorimotor control
A Randomized Controlled Trial. J.
Clin. Med. 2022, 11, 6028. https://
doi.org/10.3390/jcm11206028

Academic Editor: Hiroshi Horiuchi 1. Introduction

Received: 13 September 2022
Neck pain is the fourth leading cause for sustaining years of disability with an annual
Accepted: 10 October 2022 prevalence exceeding 30%, most often in females [1]. Biomechanically, the cervical, thoracic,
Published: 13 October 2022 and lumbar spines are interrelated [2]. Although structural causes of neck pain are not
completely understood, they are believed to be related to the interrelated functions of
Publisher’s Note: MDPI stays neutral
anatomical structures connected to the cervical spine [3]. Potentially, any event leading to
with regard to jurisdictional claims in
altered joint mechanics or muscle functions can cause neck pain [4].
published maps and institutional affil-
The thoracic spine acts as a base of support for the cervical spine and influences
iations.
its kinematics through the cervicothoracic junction [3]. Several studies have highlighted
the effect of thoracic spine abnormalities on the kinematics of the cervical spine [5–7].
Specifically, mobility restrictions in the cervico-thoracic and upper thoracic regions were
Copyright: © 2022 by the authors. reported to be associated with neck pain [5,6]. Furthermore, it has been reported that
Licensee MDPI, Basel, Switzerland. the incidence of neck disorders is increased in older adults with a concomitant higher
This article is an open access article prevalence of thoracic hyper-kyphosis [6]. This would implicate postural impairments in
distributed under the terms and the thoracic spine leading to a dysfunction of cervico-thoracic musculature such as serratus
conditions of the Creative Commons anterior, levator scapulae, and trapezius [8–10].
Attribution (CC BY) license (https:// Lau et al. reported a positive correlation between a higher upper thoracic angle and
creativecommons.org/licenses/by/ neck pain, but failed to link this to neck pain intensity [3]. In addition, Kaya and Çelenay
4.0/).

J. Clin. Med. 2022, 11, 6028. https://doi.org/10.3390/jcm11206028 https://www.mdpi.com/journal/jcm

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reported a positive correlation between thoracic curvature and neck pain and reported a
negative correlation with neck pain intensity [11]. Furthermore, neck pain populations
have been reported to have reduced trunk rotations during different speeds of walking [12].
Because changes in sagittal thoracic alignment have been reported to alter the mechan-
ical loading of the cervical spine [10,13] and decreased thoracic mobility has been identified
as one of the predictors for neck and shoulder pain [3], it makes sense that thoracic articular
treatment improves local kinematics and that simultaneously neck pain improves [7,8,14].
Thoracic kyphosis has not been uniformly correlated with neck pain intensity and
there is a general lack of investigations determining the role that rehabilitation of thoracic
kyphosis plays in improving chronic cervical spine disorders. The purpose of this study
was to investigate the immediate and 1-year effects of a multimodal program, with thoracic
hyper kyphosis rehabilitation using the Denneroll™ thoracic traction orthosis (DTTO),
applied to participants with chronic non-specific neck pain and thoracic hyper-kyphosis.
Regarding the DTTO, it is likely that a significant reduction in thoracic kyphosis will occur
due to the visco-elastic effect of the three-point bending extension traction during sustained
supine loading while on the DTTO; this has been previously reported for extension traction
devices for all regions of the sagittal plane of the spine [15–17].
The study hypothesis is two-fold: (1) the DTTO, as a three-point bending thoracic
extension device, will cause a significant reduction in thoracic kyphosis; and (2) that
the reduction in thoracic kyphosis will improve the short and long-term outcomes of
participants with chronic non-specific neck pain.

2. Methods
A prospective, investigator-blinded, parallel-group, pilot randomized clinical trial was
conducted at a research laboratory of our university and was retrospectively registered with
the Pan African Clinical Trial Registry (PACTR2019107484227). Recruitment began after
approval was obtained from the Ethics Committee of the Faculty of Physical Therapy, Cairo
University with the ethical approval No. Cairo-6-2018-11M.S. Following Ethics Committee
approval, participant recruitment began in September 2018. The participants were followed
up for 1 year (till 2019 October); all participants signed informed consent prior to data
collection. The reason behind the retrospective registration was that legislation in Egypt
only requires local registration for clinical trials and this what was completed at the outset
by prospectively registering in a non-WHO-approved registry.
We recruited a sample of 80 patients from our outpatient facility at the University of
Cairo. The Consort participant flow diagram for our study is shown in Figure 1. Participants
were screened prior to inclusion by measuring the sagittal thoracic kyphotic angle ICT-ITL
(max) using a 4D formetric device (Figure 2). After being screened by a physiotherapist, all
potential participants were invited to undergo comprehensive assessment by an orthopedist
where other causes of thoracic kyphosis were excluded. Participants were included if the
angle measured more 55 degrees. Furthermore, the patients were included if they had
chronic nonspecific NP lasting for at least 3 months, and were able to read and speak
English.
Exclusion criteria included the presence of any signs or symptoms of medical “red
flags”, a history of previous spine surgery, signs or symptoms of upper motor neuron
disease, vestibular basilar insufficiency, amyotrophic lateral sclerosis, bilateral upper ex-
tremity radicular symptoms, a history of spinal column fracture, spinal tumors and related
malignancies, congenital spinal anomalies, cancer, or rheumatoid arthritis. Furthermore,
individuals with spinal scoliosis were excluded.
Participants were randomly assigned to an intervention group (n = 40) or control group
(n = 40) according to a random number generator and restricted to permuted blocks of
different sizes, with the researcher blinded to the sequence designated for each person. The
participants in both groups completed a 10-week, 3× per week, 30 sessions total multimodal
program consisting of physical pain relief methods, thoracic spine manipulation, myofascial

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release, and therapeutic exercises. The beneficial effects for this multimodal program have
been previously reported [1,14,18–20].

Figure 1. Flow chart of participants in the study over time.

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J. Clin. Med. 2022, 11, 6028

Figure 2. The 4D Formetric device measurement of Thoracic Kyphosis and Trunk Inclination where
kyphotic angle ICT-ITL (max) is measured between tangents of cervicothoracic junction (ICT) and
of thoracolumbar junction (ITL). ICT: Inflectional points from cervical to thoracic spine. ITL: Inflec-
tional points from thoracic to lumbar spine. KA: kyphosis angle. LA: lordosis angle. VP: Vertebra
prominence. DM: Dimple.

2.1. Multimodal Program

The multimodal program was delivered by the same physiotherapist, with 10 years
of experience and training in the specific manual techniques in order to minimize inter-
therapist variation and enhance fidelity. The participants in both the control and interven-
tion groups received the multimodal program. Both groups received the same length of
multimodal treatments and the sessions lasted 30–45 min each. However, the participants
in the intervention group received an extra intervention (and time) using the Denneroll™
traction device. Thus, we attempted to provide the same time of attention equivalence in
each group provided by the treating therapist during the intervention sessions.

2.2. TENS and Heat Therapy

The participants in both groups received conventional TENS therapy (20 min). TENS
was applied over the painful area, using a frequency of 80 Hz; pulse width of 50 μs;
intensity (mA) set at the person’s sensorial threshold; modulation up to 50% of variation
frequency; symmetrical, and rectangular biphasic waveform. These parameters were set for
an optimum analgesic effect [18]. Moist hot packs (15 min) were applied prior to electrical
stimulation. The TENS and heat therapy were repeated three times per week for 10 weeks.

2.3. Soft Tissue Mobilization

Soft tissue mobilization was performed on the muscles of the upper quarter with the
involved upper extremity positioned in abduction and external rotation to preload the
neural structures of the upper limb [19]. Manual pressure was applied to the soft tissues of
the upper quadrant in a deep, stroking manner. The therapist concentrated on any tissues
on the cervical and scapular region and upper extremity that were graded as tight or tender
in the evaluation. This soft tissue mobilization was repeated three times per week for
10 weeks (30 sessions, 20 min face-to-face sessions)

2.4. Thoracic Spine Manipulation

Following the protocol previously outlined by Flynn [21], the participants were placed
in the supine position with their arms crossed and with one hand, the clinician established a
hand contact over the inferior vertebra of the identified hypomobile motion segment. With

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their second hand, a downward high velocity thrust was applied with the weight of the
clinician’s body through the patient’s elbows or forearms. This procedure was performed
at each identified segment with extension restriction range of motion determined clinically.
The initial treatment for all patients included thrust manipulation procedures consist-
ing of a high-velocity, low amplitude end-range procedure, directed at the upper, mid, and
lower spines of spinal segments identified as hypomobile during segmental mobility test-
ing. Therapists were required to perform at least 1 technique targeting the upper thoracic
spine, 1 technique targeting the mid thoracic spine, and 1 technique targeting the lower
thoracic spine during each visit for each patient. If a pop (cavitation) occurred, then the
therapist moved on to the next procedure. If not, the participant was repositioned, and
the technique was performed again. This procedure was performed for a maximum of
2 attempts.

2.5. Functional Exercises

A functional and strengthening exercise program was administered that focused
on deep cervical flexors, shoulder retractors, and serratus anterior activation and was
conducted according to the protocol described in Harman et al. [20].
Strengthening deep cervical flexors through chin tucks in supine lying with the head
in contact with the floor, the progression of this exercise was to lift the head off the floor
in a tucked position and hold it for varying lengths of time (this was to progress by
two second holds starting at two second i.e., 2, 4, 6, and 8 s). Shoulder retractors were
strengthened first while standing using a TheraBand™ by pulling the shoulders back; then
the participant was progressed to shoulder retraction in the prone position using weights.
In the standing position, the patient was asked to pinch their scapulae together without
elevation or extension in the shoulder holding this position for at least six second then
relaxing. Participants performed each of these progressive exercises for two weeks prior to
advancing to a more difficult version. At the consultation, if they could complete 3 sets of
12 repetitions correctly for the strengthening, they were progressed to the next exercise.
The progression of exercises was as follows:

(1) TheraBand™;
(2) 3 lbs;
(3) 3 lbs and TheraBand™;
(4) 5 lbs;
(5) 5 lbs and TheraBand™;
(6) 8 lbs;
(7) Using 8 lbs and TheraBand™.

The dynamic hug was performed to strengthen the serratus anterior while standing
with the back toward the wall. The participant began with the elbow flexed 45◦ , the
arm abducted 60◦ , and the shoulder internally rotated. The participant then horizontally
flexed the humerus by following an arc described by his hands. Once the participant’s
hands touched together, they slowly returned to the starting position. Participants were
instructed to complete three sets of 12 repetitions of the dynamic hug exercises. The
complete functional exercise program was to be repeated three times per week for 10 weeks.
The participants in both groups were instructed to perform neck retraction/extension,
scapular retraction, and deep upper cervical flexor strengthening exercises at home, twice
daily as their home routine. To monitor the exercise frequency performed during the study,
participants were given a pamphlet illustrating the exercises and a record sheet and were
instructed to record the time and sets of the home exercises. Mean exercise frequency per
week and mean exercise duration per day were recorded. Participants were encouraged to
perform all exercises at least twice a week for up to one year after treatment. All persons
were contacted by telephone every three months to collect the record sheets and encouraged
to maintain the training.

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2.6. Denneroll™ Thoracic Traction Orthotic (DTTO)

In addition, the participants in the intervention group received the DTTO (Denneroll
Industries, Sydney, NSW, Australia), solely during the clinical setting. Thus, the only
difference in treatments between the intervention and the control group was the application
of the DTTO Figure 3. The participants were instructed to lie flat on their back on the
ground with their knees slightly bent at 20–30◦ for comfort and arms gently folded across
their stomach. The examiner positioned the apex of the DTTO in one of three regions: lower
thoracic (T9–T12); mid-thoracic (T5–T8); and upper-thoracic (T1–T4) depending on the apex
of each participant’s thoracic kyphosis deformity. For lower thoracic kyphosis (T9–T12) the
DTTO is turned 180◦ so the peak contacts the lower thoracic spine (T10) while the tapered
end supports the mid thoracic region (Figure 3). For persons with mild–moderate posterior
thoracic or backwards tilt translation postures with more of an upper thoracic kyphosis
and anterior head translation, the DTTO is placed centered on top of a 20 mm block in
order to cause anterior shift of the thoracic spine; set up not shown. All participants began
at 3-min per session of DTTO application; at each visit they were encouraged to increase
the duration by 2–3 min, until such time they were able to reach the goal of 15–20 min
per session.

ȱ
Figure 3. Denneroll™ Thoracic Traction Orthosis (DTTO). The DTTO can be placed in the upper
(T3–T4), mid thoracic spine (T5–T8)-shown in B; or lower thoracic region (T9–T12) pending the apex
of a participant’s thoracic kyphosis and sagittal balance alignment. Each participant began lying
supine over the apex of the DTTO for 1–3 min and progress 1–3 min per session until the target of
15–20 min per session was reached. Images copyright CBP Seminars, Inc. Reprinted with permission.
Note: The individual used in the figures in this manuscript was a paid model and provided consent
for commercial use.

2.7. Outcome Measures

A series of outcome measures were obtained at three intervals: (1) baseline; (2) one
day following the completion of 30 visits after 10 weeks of treatment; and (3) one year after
the participants’ 30 session re-evaluation. The sequence of measurements was identical
for all persons. Outcome measures included: (1) kyphotic angle ICT-ITL (max) as a
primary outcome; (2) neck pain and disability (NDI); (3) sensorimotor control outcomes; (4)
head repositioning accuracy (HRA); (5) smooth pursuit neck torsion test (SPNT); and (6)
overall stability index (OSI) as secondary outcomes. All outcome assessments were carried
out with two data collectors who were blinded to group allocation to prevent potential
recorder and ascertainment bias. Participants were blinded to their measurement scores to
address potential expectation bias and were instructed not to inform the assessors of their
intervention status.

2.8. ICT-ITL (Max)

Thoracic kyphosis was assessed using a valid and reliable [22], 4D formetric device
where determination of thoracic kyphosis angle ICT-ITL (max) is measured between tan-

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gents from the cervicothoracic junction (ICT-T1) and that of the thoracolumbar junction (ITL-
T12). Participants were included if the angle measured 55◦ or more [23]. There was a good
correlation between the formetric vs. Cobb angle of thoracic kyphosis (Pearson’s r correla-
tion = 0.799) but formetric measurements consistently over-estimate thoracic kyphosis by
an average of 7◦ [23]; indicating that the T1–T12 radiographic would be a minimum of 48◦ ,
which is the upper end of normal in young adults, when the formetric angle is 55◦ [24]. See
Figures 2 and 4 for the formetric analysis in our participants.

(A)ȱ (B)ȱ

ȱ
(C)ȱ

Figure 4. Kyphosis formetric posture alignment outcomes for a sample intervention group participant
receiving the DTTO. (A) Initial baseline; (B) after 10-weeks and 30-sessions of intervention; and (C)
the 1-year follow-up assessment where no further treatment was provided over the course of one year.

2.9. Neck Disability Index

The neck disability index (NDI) to assess activities of daily living impact was adminis-
tered. The NDI has good reliability, validity, and responsiveness to change [25].

2.10. Numerical Rating Score (NRS)

Neck pain average intensity over the previous week was assessed using a 0–10 NRS
where 0 = no pain, . . . , 10 = bed ridden and incapacitated. The reliability [26] and valid-
ity [27] of the NRS is good to high.

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2.11. Sensorimotor Control Measures

Assessment of sensorimotor function included: (1) cervical joint position sense testing;
(2) head and eye movement control; and (3) evaluation of postural stability.

2.12. Cervical Joint Position Sense Testing

The valid and reliable technique [28] of head repositioning accuracy (HRA) assessment
with the CROM device was performed according to a previous protocol [29]. In an upright
seated posture on a stool with no backrest, the CROM device was placed on the participant’s
head, both feet were firmly on the floor with knees bent at an approximate 90◦ angle. The
neutral head position (NHP) was established as the beginning and reference positions
where the CROM device was adjusted to zero for the primary plane of rotational movement.
Individuals were instructed to close their eyes, memorize the starting position, actively
rotate their head 30◦ about the vertical axis, and reposition their head to the starting position
with no requirements for speed, only accuracy was encouraged. HRA was measured as the
difference in degrees in the primary plane of movement between the origin and the return
positions [30]. Participants performed three repetitions within 60 sec in each rotational left
and right directions, for a total of six sessions.

2.13. Head and Eye Movement Control: Smooth Pursuit Neck Torsion Test (SPNT)
Electro-oculography was used for the SPNT, which is an accurate means of assessing
disturbances in eye movement control [31]. The method has been described elsewhere
in detail [32]. The test was performed with the participant’s head and trunk in a neutral
forward position and then a trunk rotation position (head neutral, trunk in 45◦ rotation).
The participants were instructed to perform three blinks (for recognition and elimination
in data analysis) and then to follow the path of a light as closely as possible with their
eyes. The SPNT test value was calculated as the difference between the average gain in the
neutral and torsion positions for both left vs. right rotation.

2.14. Postural Stability

Postural stability was evaluated with a Biodex Balance System SD (BBS) (Biodex
Medical Systems, Inc., Shirley, NY, USA). Dynamic balance testing was assessed allowing
simultaneous displacements in both the anterior/posterior (AP) and medial/lateral (ML)
directions. BBS measures the deviation of each axis in the horizontal plane of the platform
during dynamic balance assessments and reports indices for ML, AP, and an overall stability
index (OSI) whereby a reduced balance correlates with large variance. Balance indices
were calculated over three 10-s trials, with 20 s of rest between trials; the average of the
three trials was recorded. The BBS was set to a dynamic position of 4 out of 8 [33]. Several
studies have used the device and have been proven to be reliable and valid for clinical
studies [34–36].
All outcome assessments were carried out by 2 assessors blinded to group allocation.
The: kyphotic angle ICT-ITL (max); neck pain and disability (NDI); sensorimotor control
outcomes; head repositioning accuracy (HRA); and overall stability index (OSI) were per-
formed by a physiotherapist with 20 years of experience in these measurement techniques
(T.S). The SPNT was conducted by an ophthalmologist (not an author) with 5 years of
experience (R. W., MD).

3. Statistical Analysis
3.1. Sample Size
A priori sample size calculation based on a non-published pilot study conducted for
9 patients, indicated that 35 participants per each group were required to detect an effect
size of 0.7 at 80% power and a significance level of 0.05 (5% chance of type 1 error). The
mean difference of the primary outcome thoracic kyphosis angle ICT-ITL (max) was 11 and
the standard deviation of this differences was 15. To account for possible drop-outs, the
sample size was increased by 10% to 40 per group.

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3.2. Data Analysis

Variance homogeneity was tested with Levene’s test, obtaining a 95% confidence
level and p-value > 0.05, and confirming variance equality. Descriptive statistics (means
± SD unless otherwise stated) were summarized at each time point. Student’s t-test for
continuous variables or chi-squared for categorical variables were performed.
The design used an intention-to-treat approach with alpha set at 0.05 level of signifi-
cance for all analyses. Comparative treatment effects of the two alternative treatments over
the course of the 1-year follow-up were examined with two-way analysis of covariance
with repeated measures, followed by the Bonferroni post hoc test. The models included
one independent factor (group), one repeated measure (time), and an interaction factor
(group × time) and gender as covariate If interactions were found (p < 0.05), the baseline
value of the outcome as covariates was used to assess between group differences. Cohen’s
d was calculated to examine the average impact of the intervention [37].
All data were analyzed using SPSS version 20.0 software (SPSS Inc., Chicago, IL, USA)
with normality and equal variance assumptions ensured prior to the analysis.

3.3. Imputation of Missing Values

To impute any missing values for the intervention and control groups, we constructed
models that included the variables related to the missing data and the variables correlated
with that outcome. The main cause of the missing data was patient dropout at the long-term
follow-up measurement interval at 1 year. The outcome measures at 1-year follow up were
missing for three patients from the experimental group and seven patients from the control
group (reasons for dropout are depicted in Figure 1). As the missing data were at the
end of the trial, the last present value was carried forward. Imputation models included
corresponding outcome values measured at baseline, then at 10 weeks. Other variables
included in the imputation model were selected based on maximizing the correlation with
the variable imputed. The characteristics which were associated with the variable imputed
in the regression analysis were age, sex, and smoking status. This imputation created five
complete datasets according to Rubin’s method [38]. Pooled results were used for data
analysis. We conducted a sensitivity analysis comparing the results from the imputed data
to the original dataset, and the results were similar.

4. Results
Two hundred participants were initially recruited and screened, of whom 80 met the
inclusion criteria and agreed to participate in the study. Three persons in the intervention
group and seven in the control group resigned at 1-year follow-up for business and personal
reasons. Figure 1 presents this information.

4.1. Baseline Demographics and Characteristics

The intervention and control groups were comparable for age, weight, sex, marital
status, pain duration, and smoking status, indicating randomization was successful for
these variables. Table 1 reports this data.

Table 1. Baseline participant demographics. Interventional group (Int.) is the group receiving stan-
dard care plus the Denneroll™ thoracic traction orthotic (DTTO). Control group (Con.) is the group
receiving standard care only. Values are expressed as means ± standard deviation where indicated.

Int. Group (n = 40) Con. Group (n = 40)

Age (y) 25.05 ± 3 24 ± 4.2
Weight (kg) 66 ± 10 60 ± 9
Sex
Male 28 (70%) 30 (75%)
Female 12 (30%) 10 (25%)
Single 31 (77.5%) 29 (72.5%)
Married 9 (22.5%) 11 (27.5%)

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Table 1. Cont.

Int. Group (n = 40) Con. Group (n = 40)

Separated, divorced, or widowed 0 0
Pain duration (%) [Mean ± SD]
11 (27.5%) 9 (22.5%)
1–3 y
[5.3 ± 2] [5.8 ± 1]
16 (40%) 18 (45%)
3–5 y
[4.9 ± 1.5] [5.4 ± 1.3]
13 (32.5%) 15 (37.5%)
>5 y
[4.8 ± 2] [5.7 ± 0.9]
Smoking
Light smoker 15 (37.5%) 18 (45%)
Heavy smoker 4 (10%) 2 (5%)
No Smoker 21 (52.5%) 20 (50%)

4.2. Between Group Analysis

A general linear model using repeated measurements identified significant group ×
time effects in favor of the intervention DTTO group for the following outcomes: thoracic
kyphosis angle (ICT-ITL (max); NDI, NRS pain intensity; HRA for right and left rotation
repositioning accuracy; SPENT, posture stability measured as the OSI. Table 2 reports
the thoracic kyphosis outcomes, Table 3 reports the NDI and pain intensity while Table 4
reports the sensorimotor control outcomes.

Table 2. The changes in sagittal alignment management outcomes in experimental and control groups
vs. time. Kyphotic angle ICT-ITL max = angle of kyphosis between tangents of cervicothoracic junction
(ICT) and of thoracolumbar junction (ITL). Values are mean ± standard deviation. G = group; T = time;
I = intervention group; C = control group; C.I. [] = 95% confidence interval; p = statistical significance;
C.I. [] = 95% confidence interval; Cohen’s d value = d; * indicates statistically significant difference.

1-Year Cohen’s d Cohen’s d p-Value

Baseline 10-Weeks Follow up 10-Weeks vs. 1-Year vs.
Baseline Baseline G T G vs. T

ICT-ITL I 82.15 ± 5.3 63.40 ± 6.2 64.6 ± 5.7 d = 3.2 d = 3.18 <0.001 * <0.001 * <0.001 *
max C 83.15 ± 4.9 82.2 ± 4.5 83.8 ± 3.8 d = 0.2 d = −0.14
<0.001 *
p-value 0.5 <0.001 *
[−22.9,
C.I. [−4.3, 2.3] [−22.3, −16.1]
−15.8]

Table 3. The changes in pain and disability outcomes in interventional (DTTO) and control groups vs.
time. NDI = neck disability index; Pain intensity is 0–10 where 0 is no pain and 10 is incapacitated;
I = interventional group; C = control group; G = group; T = time; G vs. T = group vs. time; all values
are expressed as means ± standard deviation; C.I. [] = 95% confidence interval; Cohen’s d value = d;
* indicates statistically significant difference.

1-Year Cohen’s d Cohen’s d p-Value

Baseline 10-Weeks Follow up 10-Weeks vs. 1-Year vs.
Baseline Baseline G T G vs. T
I 31.1 ± 3.2 20.6 ± 4.5 10.9 ± 2.4 d = 2.6 d = 7.14 <0.001 * <0.001 * <0.001 *
NDI
C 32.2 ± 2 29 ± 3.9 28.1 ± 5.1 d = 1.03 d = 1.05
p-Value 0.6 <0.001 * <0.001 *
95% C.I. [−2.28, 0.08] [−10.27, −6.52] [−18.9, −15.4]

Pain I 5 ± 1.5 1.4 ± 1.2 0.5 ± 1 d = 2.65 d = 3.53 <0.001 * <0.001 * <0.001 *
intensity C 5.6 ± 1 2.9 ± 0.9 3.2 ± 1.6 d = 2.8 d = 1.7
p-Value 0.04 <0.001 * <0.001 *
95% C.I. [−1.16, −0.03] [−1.07, −0.12] [−3.29, −2.1]

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Table 4. The changes in posture control outcomes in experimental and control groups vs. time.
SPENT = smooth pursuit neck torsion test; OSI = biodex balance test; HRA = head repositioning error
in rotation right and left side; I = interventional group; C = control group; G = group; T = time; G vs.
T = group vs. time; all values are expressed as means ± standard deviation; C.I. [] = 95% confidence
interval; Cohen’s d value = d; * indicates statistically significant difference.

Cohen’s d Cohen’s d p-Value

1-Year
Baseline 10-Weeks 10-Weeks vs. 1-Year vs.
Follow-up G T G vs. T
Baseline Baseline
HRA I 3.4 ± 1.4 2.1 ± 1.3 2 ± 1.5 d = 1.4 d = 1.3 <0.001 * <0.001 * <0.001 *
Right C 4 ± 1.5 2.7 ± 1.1 3.2 ± 1.6 d = 0.9 d = 0.51
p-value 0.06 0.02 * <0.001 *
C.I. [−1.24, 0.04] [−1.13, −0.06] [−1.89, −0.5]

HRA I 4.3 ± 1.4 2.6 ± 1.4 1.8 ± 1.1 d = 1.21 d = 1.98 <0.001 * <0.001 * <0.001 *
Left C 3.7 ± 1.6 2.9 ± 1.6 2.8 ± 1.2 d = 0.5 d = 0.63
p-value 0.07 0.3 <0.001 *
C.I. [−0.06, 1.26] [−0.96, 0.36] [−1.51, −0.48]
I 0.41 ± 0.17 0.28 ± 0.1 0.18 ± 0.09 d = 0.93 d = 1.6 <0.001 * <0.001 * <0.001 *
SPENT
C 0.34 ± 0.16 0.3 ± 0.06 0.29 ± 0.12 d = 0.09 d = 0.35
p-value 0.06 0.48 <0.001 *
C.I. [−0.003, 0.14] [−0.06, 0.02] [−0.15, −0.06]
I 0.62 ± 0.13 0.46 ± 0.1 0.41 ± 0.2 d = 1.37 d = 1.24 <0.001 * <0.001 * <0.001 *
OSI
C 0.57 ± 0.11 0.52 ± 0.16 0.58 ± 0.19 d = 0.364 d = −0.06
p-value 0.06 0.047 * <0.001 *
C.I. [−0.003, 0.103] [−0.11, −0.0007] [−0.25, −0.08]

4.3. The 10-Week Evaluation

- Thoracic kyphotic angle
Significant differences were found between groups, favoring the intervention group
for kyphotic angle ICT-ITL (max) (p < 0.001) with an approximate 19◦ reduction in kyphosis
angle for the DTTO group. These data, including effect sizes for both groups, are reported
in Table 2. See also Figure 4 for a representative example of the changes.
- NDI and Pain Intensity
Following 30 treatment sessions, the between-group statistical analysis, showed better
improvements for the intervention vs. control group in NDI (p < 0.001) and pain intensity
(p < 0.001). These data, including effect sizes for both groups, are reported in Table 3.
- Sensori-motor control
Both groups improved similarly for two sensori-motor control outcomes where no
group differences were found for: left sided HRA (p = 0.3) and SPNT (p = 0.48). In
contrast, the intervention group had significantly greater improvements for two sensori-
motor control measurements: right sided HRA (p = 0.02) and OSI (p = 0.047). These data,
including effect sizes for both groups, are reported in Table 4.

4.4. One-Year Follow-up

Between group analysis identified a regression back to baseline values for the control
group outcomes. Thus, all variables were significantly different favoring the intervention
group at 1-year follow-up. Kyphotic angle ICT-ITL (max) maintained its improvement
(p < 0.001), with an 18◦ overall improvement from baseline in the DTTO group; see Table 2.
Pain and disability were significantly improved in the intervention group vs. the control
group: NDI (p < 0.001); neck pain intensity (p < 0.001). Sensori-motor measures were
also significantly improved in the intervention group compared to the control: HRA-right

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(p < 0.001); HRA-left (p < 0.001); SPNT (p < 0.001); OSI (p < 0.001); see Tables 3 and 4.
Cohen’s d and effect size (r) for both groups for all variables are reported in Tables 2–4.

5. Discussion
The current study presented a two-fold hypothesis: first, that the DTTO would cause a
significant reduction in thoracic kyphosis, and two, that the reduction in thoracic kyphosis
would improve the short and long-term outcomes of participants with chronic non-specific
neck pain with concomitant hyper thoracic kyphosis. The differences between our interven-
tion and control groups identified an 18–19◦ reduction in thoracic kyphosis in the group
receiving the DTTO at both the 10-week and 1-year follow-up, while the control group’s
kyphosis angle remained unchanged. Concerning the sensorimotor control group’s mea-
surements at 10-weeks, two out of the four assessments identified a significant difference
in favor of the DTTO group (OSI-balance and Right HRA) and at the 1-year follow-up all of
the measures were significantly different in favor of the DTTO group. Thus, both of the
hypotheses of our investigation were confirmed by these findings. To our knowledge, this
is the first study to provide clear evidence that rehabilitation of thoracic hyper-kyphosis
influences these specific outcomes in chronic neck pain sufferers with hyper-kyphosis.

5.1. Thoracic Kyphosis Improvement

Thoracic hyper-kyphosis represents one of the top four spine abnormalities associated
with adult spine deformity (ASD), a world-wide, known set of disabilities affecting adults
over the age of 18 years [39–41]. For example, Pellise et al. [39]. identified that patients
with thoracic kyphosis over 60◦ had significantly lower health-related quality of life scores
compared to patients afflicted with four other major health disorders (Type II diabetes,
rheumatoid arthritis, heart disease, pulmonary disease). While 60◦ is the recommended cut-
point for thoracic hyper-kyphosis in ASD populations, other investigations have identified
that the cut-point between those with pain, lower self-image, and decreased function is
45◦ [42–44].
Due to the volume of investigations, identifying thoracic kyphosis is a considerable
cause of pain, disability, and reduced quality of life outcomes, conservative treatment
strategies to reduce its magnitude are critically necessary. To this end, it is generally
considered that effective interventions for postural thoracic hyper-kyphosis should include
specific rehabilitation exercises and practiced forced idealized posture alignment in stance
and in sitting [44–46]. In more severe cases, or in cases with Scheuermann’s kyphosis, a
sagittal plane corrective orthosis brace is recommended [45].
A recent systematic literature review with meta-analysis identified that strengthening
exercises have a considerable effect on thoracic kyphosis reduction when applied over the
course of an average of 12.5 weeks with three sessions per week [44]. Considering only the
homogenous exercise studies, an approximate reduction in thoracic kyphosis of 5◦ or less
was identified [44]. More recently, in a small scale RCT with low power, Bezalel et al. [46].
identified a significant reduction in thoracic kyphosis (9◦ –10◦ reduction) in patients with
Scheuermann’s kyphosis receiving the Schroth series of exercises and stretches to reduce
kyphosis. Initially, patients had a 60◦ kyphosis on X-ray (Cobb T3–T10) and inclinometry
(T1–T12) that was reduced to approximately 50◦ .
In the current investigation, we used a four-D formetric scanner to evaluate thoracic
kyphosis and our average participant’s kyphosis was 82◦ which was reduced by 18◦ down
to 64◦ in the group receiving the DTTO. For comparison, it is known that the formetric
and inclinometry measures of external thoracic kyphosis overestimate the radiographic
determined thoracic kyphosis by approximately 7◦ and maybe more depending on the
unique population [23,46,47]. It is likely that our current participant population had
a radiographic determined thoracic kyphosis that averaged at least 60◦ depending on
the vertebral levels of measurement. Further, we estimated our radiographic kyphosis
reduction to be between 12◦ –15◦ based on existing comparative population data; making

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our results one of the largest conservative reductions in thoracic kyphosis reported in an
RCT in the literature to date [44,46].
Arguably, adults with a large increased thoracic kyphosis (60◦ –80◦ ) that is ‘fixed’
(Scheuermann’s kyphosis and other deformities) would seem not to be amenable to physical
maneuvers (exercise and manipulation); however, they are able to be reduced with three-
point bending thoraco-lumbar braces [45]. Similarly, extension traction devices such as the
DTTO use the principles of three-point bending as in braces; although extension traction
devices are shorter duration applications with higher loading [15–17]. Though we did not
specifically investigate the difference between more rigid vs. more flexible thoracic kyphotic
deformities, our population did indeed have a large increase in thoracic kyphosis compared
to that found in a healthy population [24,42–44]. We speculate that the large and significant
reduction in thoracic kyphosis found in our DTTO group is due to the visco-elastic effect
of three-point bending extension traction during sustained supine loading while on the
DTTO. Our results are generally consistent with previous investigations looking at patients
treated with different types of thoracic spine three-point bending extension traction devices;
however, these previous investigations suffer from a lack of controls and small sample
sizes [15]. Future investigations should use radiography to determine the type of thoracic
hyper-kyphosis, its flexibility, and its amenability to three-point bending extension devices
such as the DTTO.

5.2. Pain, Disability, and Sensorimotor Control

The assumption that restoring thoracic sagittal plane posture should improve cervical
spine pain and kinematics has evidence in the literature. For instance, it has been proposed
that upper thoracic kyphosis increases the T1-slope into a more flexed posture and this, in
turn, creates a situation of forward head posture, increased strain on the cervical-thoracic
muscles and ligaments [15,39,40]. For example, Kaya and Çelenay reported a positive
correlation between thoracic curvature and neck pain [11]. Furthermore, abnormal head
posture can result in altered joint position and dysfunction that can lead to pain and
abnormal afferent information [10,48].
Forward head translation causes both a reduced range of movement and an altered
segmental cervical spine kinematic pattern [10]. Thus, altered sagittal cervical spine align-
ment from thoracic hyper-kyphosis could potentially result in abnormal sensorimotor
integration through changes in afferent input as a direct consequence of altered cervical
spine kinematics and altered soft tissue strains [48]. The current study’s findings of reduced
neck pain, disability, and improved sensorimotor control in the DTTO group add credence
to the above biomechanical and clinical investigations detailing the effects of thoracic spine
abnormalities on the cervical spine. Treating the spine as a synchronized kinetic chain
should be considered the standard particularly in cases of chronic non-specific neck pain
with concomitant thoracic hyper-kyphosis.

5.3. Limitations and Summary

The current study has limitations to consider which should lead to future investi-
gations. First, we did not use participant and treatment provider blinding. However,
examiners did not discuss the clinical importance of correcting the thoracic kyphosis in
either group in order to account for the placebo effect in the DTTO group and a possible
nocebo effect in the control group at long term follow-up. Second, the participants were
a convenience sample of young adults from an out-patient facility and thus may not be
representative of all patients with chronic non-specific cervical spine complaints. Third, the
outcome measures we used to verify if correction of thoracic kyphosis alignment improves
sensori-motor control, pain, and disability may not be the only or the ideal assessments for
CNSNP outcomes. Fourth, we measured the thoracic kyphosis using an external posture
assessment device and this does not provide the same quantitative data as radiographic or
other advanced imaging methods for measurement of thoracic kyphosis.

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Finally, both groups received the same time and number of sessions for the multi-
modal treatments. However, the participants in the intervention group received an extra
intervention (and time) using the Denneroll™ thoracic extension traction device. We at-
tempted to provide the same time of attention equivalence in each group provided by the
treating therapist during the intervention sessions. However, as attention and interpersonal
interactions alone may influence pain, and other health outcomes, this is a limitation to the
study design in as much as the groups did not receive equal interventions. Importantly
though, previously, it has been identified that when a placebo device is added to the control
groups’ interventions to mimic the time and number of sessions on the Denneroll™ in the
cervical spine, that the placebo device did not influence the outcomes of neck pain and
disability [49]. Still, this is something that should be addressed in future projects.

6. Conclusions
Notwithstanding the study limitations, the unique contribution of the current inves-
tigation is that we determined thoracic hyper-kyphosis reduction plays a significant role
in improving both the short and long-term outcomes in patients suffering from chronic
nonspecific neck pain. In these relevant populations, it would seem of value to reha-
bilitate thoracic hyper-kyphosis abnormalities towards normal alignment as a primary
management strategy. The DTTO investigated in this study is a simple orthotic that can be
prescribed for home use or utilized under the supervision of a treating clinician as used in
this investigation.

Author Contributions: I.M.M., T.M.S. and D.E.H. conceived the research idea and participated in
its design; I.M.M., T.M.S., L.M.W., V.R. and D.E.H. all contributed to the statistical analysis; I.M.M.,
T.M.S., L.M.W. and V.R. participated in the data collection and study supervision; I.M.M., T.M.S.,
L.M.W., V.R. and D.E.H. all contributed to the interpretation of the results and wrote the original and
final drafts. All authors have read and agreed to the published version of the manuscript.
Funding: The thoracic Dennerolls used in this study were funded by Denneroll Industries, Inter-
national P/L of Wheeler Heights, NSW 2097, Australia. CBP NonProfit funded author travel and
conference fees to present this abstract at combined sections meeting of the Academy of Orthopaedic
Physical Therapy, Denver, CO, 2020.
Institutional Review Board Statement: The study was conducted in accordance with the Declara-
tion of Helsinki, and approved by the Ethics Committee of the Faculty of Physical Therapy, Cairo
University with the ethical approval No. Cairo -6-2018-11M.S. Following Ethics Committee ap-
proval, participant recruitment began in September 2018. The participants were followed up for
1 year (till October 2019); all participants signed informed consent prior to data collection. The
reason behind the retrospective registration was that legislation in Egypt only requires local regis-
tration for clinical trials and this what was completed at the outset by prospectively registering in a
non-WHO-approved registry.
Informed Consent Statement: Written informed consent was not obtained for the person depicted
in Figure 2 as this is a photo from a model production shoot and the copyright holder is an author
(DEH) on the manuscript and has provided consent for this image to be reproduced.
Data Availability Statement: The datasets analyzed in the current study are available from the
corresponding author on reasonable request.
Conflicts of Interest: D.E.H. teaches rehabilitation methods and sells the Denneroll™ products to
physicians for patient care as used in this manuscript. D.E.H. is not a patent holder for the Denneroll™
products. All the other authors declare that they have no competing interest.

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Clinical Medicine

Article
Post-Traumatic Atlanto-Axial Instability: A Combined Clinical
and Radiological Approach for the Diagnosis of Pathological
Rotational Movement in the Upper Cervical Spine
Bertel Rune Kaale 1, *, Tony J. McArthur 1 , Maria H. Barbosa 1 and Michael D. Freeman 2

1 Firda Medical Center AS, 6823 Sandane, Norway

2 CAPHRI School for Public Health and Primary Care, Faculty of Health, Medicine, and Life Sciences,
Maastricht University, 6211 LM Maastricht, The Netherlands
* Correspondence: [email protected]

Abstract: Post-traumatic rotational instability at the atlanto-axial (C1-2) joint is difficult to assess,
much less quantify, due to the orientation and motion plane of the joint. Prior investigations have
demonstrated that a dynamic axial CT scan, during which the patient maximally rotates the head
right and left, can be used to evaluate and quantify the amount of residual overlap between the
inferior articulating facet of C1 and the superior facet of C2, as an index of ligamentous laxity at
the joint. We have previously demonstrated that a novel orthopedic test of rotational instability, the
atlas-axis rotational test (A-ART), may have utility in identifying patients with imaging evidence
of upper cervical ligament injury. In the present investigation, we assessed the correlation between
a positive A-ART and a CT scan assessment of the relative quantity of residual C1-2 overlap, as a
percent of the superior articulating facet surface area of C2. A retrospective review was conducted of
the records of consecutive patients presenting to a physical therapy and rehabilitation clinic, over a
5-year period (2015–20) for chronic head and neck pain after whiplash trauma. The primary inclusion
criteria were that the patient had undergone both a clinical evaluation with A-ART and a dynamic
axial CT to evaluate for C1-2 residual facet overlap at maximum rotation. The records for a total
Citation: Kaale, B.R.; McArthur, T.J.; of 57 patients (44 female/13 male) were identified who fit the selection criteria, and among these,
Barbosa, M.H.; Freeman, M.D. there were 43 with a positive A-ART (i.e., “cases”) and 14 with a negative A-ART (i.e., “controls). The
Post-Traumatic Atlanto-Axial analysis demonstrated that a positive A-ART was highly predictive of decreased residual C1-2 facet
Instability: A Combined Clinical and overlap: the average overlap area among the cases was approximately one-third that of the control
Radiological Approach for the group (on the left, 10.7% versus 29.1%, and 13.6% versus 31.0% on the right). These results suggest
Diagnosis of Pathological Rotational that a positive A-ART is a reliable indicator of underlying rotational instability at C1-2 in patients
Movement in the Upper Cervical with chronic head and neck symptoms following whiplash trauma.
Spine. J. Clin. Med. 2023, 12, 1469.
https://doi.org/10.3390/jcm12041469
Keywords: upper cervical instability; atlas-axis rotational test (A-ART); CT scan; whiplash trauma
Academic Editors: Deed Harrison,
Ibrahim Moustafa and Paul Oakley

Received: 20 January 2023

1. Introduction
Revised: 8 February 2023
Accepted: 10 February 2023 Intervertebral instability secondary to intervertebral ligamentous injury is a relatively
Published: 12 February 2023 common finding among patients with whiplash trauma-related chronic neck pain [1]. The
clinical presentation can be particularly complicated when the instability is in the upper
cervical spine (i.e., between the occiput, atlas, and axis [C0-2]), as patients may suffer from
nonspecific symptoms of headache, vertigo, and neck pain, the origin of which can be
Copyright: © 2023 by the authors. difficult to pinpoint [2].
Licensee MDPI, Basel, Switzerland. The diagnosis of symptomatic spinal instability requires a combination of symptoms
This article is an open access article consistent with the condition, and radiographic evidence of extra-physiologic movement
distributed under the terms and
at the joint in the relevant plane and direction, which may or may not be accompanied by
conditions of the Creative Commons
MRI evidence of ligamentous disruption. A diagnosis of anterior or posterior instability of
Attribution (CC BY) license (https://
the sub-axial spine (C2–C7) may be made via flexion and extension radiographs, or more
creativecommons.org/licenses/by/
involved evaluations of wider range of movements can be accomplished via fluoroscopic
4.0/).

J. Clin. Med. 2023, 12, 1469. https://doi.org/10.3390/jcm12041469 https://www.mdpi.com/journal/jcm

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J. Clin. Med. 2023, 12, 1469

examination [1]. In contrast, the evaluation and diagnosis of instability in the upper
cervical spine is made more difficult by the anatomical complexity and predominant type
of movement of the joints, which is rotation about the vertical axis [3]. Thus, while lateral
flexion instability of C1 on C2 can be evaluated dynamically with anterior to posterior open
mouth radiographs, excessive rotational movement can only be evaluated via imaging in
an axial (up to down) orientation.
There are two prior studies that have described the use of CT scanning to assess the
degree of rotational movement at C1 on C2 by quantifying the loss of facet joint surface
overlap at maximum voluntary head rotation. The first study, from 1999, evaluated an
uninjured population of 10 children, and described a maximal joint contact loss of 74 to
85% [4]. The second study, published 10 years later, evaluated the percent decrease of joint
overlap in a healthy group of 40 adults at maximal head rotation, finding an average loss
of 70% of joint overlap (range 42–86%), thus leaving an average residual overlap area of
30% [5]. No other publications describing an investigation of the technique in either healthy
or injured populations were identified, following a search of the literature using key terms.
In 2008, Kaale and colleagues described a novel clinical examination protocol for
evaluating upper cervical rotational instability (UCRI) called the “atlas-axis rotational
test,” abbreviated as “A-ART” henceforth [6]. The orthopedic test is performed on a
passive seated patient, by palpating and stabilizing the transverse process of C2 while
rotating the patient’s head and palpating the degree of end play of the lateral mass of C1 at
maximal tolerable rotation, see Figure 1. Instability of C1 on C2 is graded 0–3 based on the
perceived degree of abnormality of end play. The authors compared the A-ART results of
122 patients to MRI evaluation of the integrity of the upper cervical ligaments (alar and
transverse) and tectorial and posterior atlanto-occipital membranes. When the clinical test
results were dichotomized as either normal (0–1) or abnormal (2–3), there was good to
excellent agreement (i.e., kappa coefficient of 0.7–0.9) between the ability of the A-ART
rotational test to detect abnormal joint end play and the MRI confirmation of ligamentous
abnormality. Although these results were encouraging, they could not confirm that the
instability inferred from the dynamic clinical examination was in fact correlated with actual
instability, as the MRI evaluations were performed in a neutral position, and thus cannot
be considered a “gold standard” test of rotational instability of C1 on C2. The validation of
A-ART for the detection of UCRI would have utility in the medicolegal investigation of
the pain source in patients with chronic symptoms suggestive of upper cervical instability
following whiplash trauma, as the test could help identify patients with a higher likelihood
of positive objective imaging indicative of traumatic injury.

Figure 1. Examiner hand position during the atlas-axis rotational test (A-ART). While standing
behind the seated patient, the examiner places both hands on the occipito-cervical junction, opposite
the side of head rotation. With the 2nd and 3rd fingers, the examiner’s lower hand (right, in the

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photograph) is used to stabilize and traction posteriorly against the transverse process of C2. The 2nd
and 3rd fingers of the other hand (left, in the photograph) contact the mastoid process of the occiput
and lateral mass of the atlas, respectively. The test is then performed with varying angles of cervical
rotation, to locate the position that yields maximal movement between C1 and C2, and graded by the
amount of C1 versus C2 movement described in the text. For the purposes of the present study, a
grade of 0–1 equates to little perceived relative rotational motion between the transverse processes of
C1 and C2 (subjectively gauged, less than ~5 mm), and 2 or more exceeds this threshold.

In this study we present the results of an investigation of the correlation between the
results of a dynamic orthopedic test for UCRI (the A-ART) and a dynamic imaging analysis
of UCRI, via residual C1-C2 facet overlap analysis. The purpose of the investigation is
to assess the diagnostic accuracy of the A-ART using a direct radiographic measure of
excessive joint excursion and instability.

2. Methods
2.1. Inclusion Criteria
The data used for the analysis were retrospectively abstracted from medical records
and imaging files for patients who had been referred by their general practitioner (GP) to a
single physiotherapy and rehabilitation practice for evaluation and treatment of chronic
post-traumatic neck pain (range 4 to 8 years after injury), from 2015 through 2020. The
primary inclusion criteria for the study were that (1) there was a relatively high clinical
suspicion of UCRI based on the clinical presentation, and (2) both the A-ART and a dynamic
rotational CT scan were performed on the patient.
The clinical suspicion of UCRI was based on the presence of chronic (i.e., >6 months
duration) neck pain complaints combined with symptoms potentially of a craniocervical
origin, including dizziness, headache, and a sense of head pressure, including a worsening
of the symptoms with head rotation, including during normal activities. The provoked
symptoms in some cases would persist for hours to days. The A-ART was performed
on the patients by 2 blinded clinicians, and graded 0 to 3. and the patient was subse-
quently referred to an outpatient imaging center for a CT scan of the upper cervical spine
which included a dynamic rotational stress protocol. As noted above, prior to the CT
scan, all of the patients had a cervical MRI study in order to rule out significant CNS or
musculoskeletal pathology.
A total of 57 patients (44 female/13 male) were identified for study, after the exclusion
of one patient with a suspected connective tissue disorder. For the purposes of the study,
most accurately described as a prospective cohort design, patients were dichotomized into
2 groups by A-ART grade, following the same protocol described by Kaale et al. [6], in
which a result of 2–3 was deemed “abnormal” or positive for UCRI (little to no stop feeling
of C1 lateral mass at the end of rotation), and 0–1 was deemed “normal” and negative
for UCRI (solid or soft stop feeling during rotation). See Figure 1. Two physiotherapist
examiners, both experienced with application of the A-ART, had to agree that the A-ART
grade was 2 or 3 for the patient to be categorized in the “abnormal” group. As these data
were gathered retrospectively, no protocol was in place to blind the second examiner to
the first examiner’s finding, and thus the level of inter-examiner agreement between initial
findings could not be reconstructed. For further analysis, the patients with an abnormal
A-ART result were deemed as “cases” and the patients with a normal A-ART test were
deemed “controls”.

2.2. CT Scan Protocol

Referral for the CT scan was provided by the referring GP, and was based on either a
high degree of suspicion of UCRI among the 43 patients with a positive A-ART, or to rule
out other cervical spine pathology (including UCRI) in the 14 A-ART negative patients.
The CT scan was performed on the same day (and at the same facility) as a cervical MRI
study, which was ordered at the same time at the CT scan. All patients were provided

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J. Clin. Med. 2023, 12, 1469

with information regarding the risks of the procedure, and given the alternative to opt out
of the diagnostic study as part of the procedures, alternatives, and risk (PAR) conference.
The scans were obtained from just above the base of the skull to the T1/T2 level, and
performed on a Toshiba Aquilion ONE CT scanner, using 80 kVp and 80 mAs, with a 0.5 s
scan time. Bone and soft tissue target algorithms were used, and the scans were performed
without gantry angulation. The scans were 0.5 mm thick and were obtained in one single
volume of 160 mm and reconstructed as 0.5mm axial slices every 0.25 mm, yielding a total
of 320 × 0.25 mm axial slices. The 2 rotational scan sequences were each approximately
4 min in duration.
The entire cervical spine scan was performed with the patient’s head in a neutral
position, and then upper cervical images were obtained with the head in maximal tolerable
rotation, so as to reproduce the conditions of the A-ART in a supine position, using
previously described upper cervical imaging protocol [7,8]. 3D Volumetric CT scans were
reviewed on a Vitrea (Vital Images) workstation using both 3D and cross-sectional imaging
techniques. The total scan dose was 2.2 mSv (millisieverts). For reference, the doses of an
abdominal CT scan and single chest X-ray are 10 and 0.02 mSv, respectively [9].

2.3. CT Scan Interpretation

The neutral position scans were first evaluated for significant pathology, which were
negative for all patients. To evaluate the atlas-axis facet coverage at maximal rotation, the
axial slices that optimized the view of the cortical rim around the facets was used. The
joint surface of the superior facet of C2 was then identified, and the online software pro-
gram GeoGebra Classic (http://www.geogebra.org/) was used to delineate the anatomical
perimeter of the articulating surface, as well as quantify the area [10]. Next, the posterome-
dial margin of only the part of the inferior articulating surface of C1 that was overlapping
with the C2 superior facet surface was outlined, and the area of overlap was calculated by
the software as a percentage of the area of the C2 joint surface, see Figure 2a–c.

Figure 2. (a) CT scan, axial view, with the patient’s head rotated maximally to the left. The notched
arrow points to the right superior articulating facet of C2, and the striped arrow points to the right
inferior articulating facet of C1. (b) The same scan as in Figure 2a, with the outer margin of the
right superior articulating facet of C2 outlined using the GeoGebra software, resulting in an area
of 18.9 cm2 . (c) The same scan as depicted in Figure 2a and b, but with the residual overlapping
area of C1 and C2 outlined using the GeoGebra software, resulting in an area of 0.9 cm2 . The area of
residual overlap, as a percent of the total area of the superior articulating facet of C2, is calculated as
(0.9/18.9 × 100%), and is thus 4.8%. (R—right, L—left, A—anterior, P—posterior).

2.4. Statistical Analysis

Welch’s Two-Sample t-test was used to analyze the differences in the mean values
of right and left overlap percentage, as well as the distribution of age between the case
and control groups. The multivariate relationships between right and left overlap and age

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J. Clin. Med. 2023, 12, 1469

between the 2 groups were analyzed using generalized linear modeling. The Kolmogorov–
Smirnov (K-S) test of normality was used to assess the distribution of the ages in each
group. A p-value of 0.05 or lower was considered statistically significant for all analyses,
which were performed using RStudio, version 2022.020 + 443 (RStudio Team: Integrated
Development for R. RStudio, PBC, Boston, MA, USA).

2.5. Consent
All patients were contacted and asked for consent for their anonymized archived
medical information to be used for the present investigation. All patients gave consent.
This study was exempted from ethics review because of the use of archived medical
information, which was described collectively, rather than individually.

3. Results
Both right and left overlap percentages were significantly lower among the patients
with an abnormal A-ART, versus the patients with normal tests (see Table 1). The average
percentage of overlap among the cases was approximately one-third of the average in
the control group (10.7% versus 29.1% on the left, and 13.6% versus 31.0% on the right).
Although the right side values were slightly higher than the left side values in both groups,
the difference was not significant. While normally distributed in both groups (i.e., K-S was
not significant), age was significantly lower in the patient group; on average, the cases were
8.1 years younger than the control group, with a range of ages among the cases of 15 to 70,
and 28 to 77 for the controls. There was a nominal disparity in sex distribution between
cases and controls, with 10/43 (23%) males in the former, and 3/14 (21%) males in the latter.
Multivariate linear regression was used to examine the role of age and sex as a predictor of
overlap; however, no significant associations were discerned.

Table 1. Mean Values (Standard Deviations, SD) of percent of atlanto-axial residual facet overlap at
the extreme of right and left rotation, and average difference between the 2 groups (95% confidence
intervals [CI]), and age distribution among 43 cases and 14 controls.

Mean Values (SD)

N Female/Male R Overlap L Overlap Age (Years)
39.8 (12.27)
Cases 43 33/10 13.6% (5.81) 10.7% (5.06)
Range 15–70
47.9 (12.83)
Controls 14 11/3 31.0% (10.11) 29.1% (11.15)
Range 28–77
p-value <0.001 <0.001 0.0499
Mean difference 17.4% 18.4% 8.1 years
(95% CI) (11.5, 23.3) (12.0, 24.8) (0.02, 16.2)

4. Discussion
The results of the present investigation are noteworthy in two respects; they demon-
strate the potential utility of axial CT scanning for the objective evaluation of rotational
instability in patients with symptoms consistent with upper cervical instability, and they
provide quantitative objective evidence of the clinical utility of the A-ART for identify-
ing rotational ligamentous instability at C1-2. Both findings are unique in the literature.
Prior investigations of upper cervical rotational instability have primarily focused on the
evaluation of injury to the alar ligaments.
Despite the fact that the 14 subjects in the control group were seeking treatment
for persisting craniocervical symptoms following a cervical spine trauma (i.e., whiplash
trauma), the average residual atlanto-axial overlap in the control group of approximately 29
to 31% (left and right, respectively) fell well within the range described by Mönckeberg and
colleagues in an asymptomatic population of 40 adults (30%) [5]. In contrast, the residual
overlap among the cases in the present investigation fell outside the range observed in

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the prior asymptomatic population study, in which the lowest residual overlap of any of
the subjects was 14.3%, versus the 10.7% and 13.6% (left and right, respectively) average
among the cases.
Aside from significantly lower residual overlap at C1-2, the distinguishing feature
among the cases, versus the controls, was an abnormal A-ART. It is thus reasonable to infer
from these findings that the A-ART is a relatively accurate test for atlanto-axial rotational
instability, although the degree of accuracy cannot be quantified from these data, as there is
no gold standard threshold or cut point to measure the individual findings against. While
the findings may also be attributable to an unexamined confounding factor related both to
instability and the A-ART (aside from sex and age, which were not found to be correlated
in the analysis), this explanation is unlikely, given that the pathomechanics resulting in the
decreased C1-2 facet overlap would also reasonably result in a palpable alteration in joint
end play (and abnormal A-ART result). The authors have not observed any negative effects
during administration of the A-ART; however, we advise a slow and cautious approach
any time maximal head rotation is assessed in the patient with suspected ligamentous
instability in the upper cervical spine, keeping in mind the proximity of the bony structures
to the upper cervical spinal cord.
As noted in Section 2, all of the patients underwent an upper cervical CT scan on
the same day that they underwent a cervical MRI study. A look back at the MRI images
revealed that the majority did not include the C1-2 levels, and thus the correlation between
the CT scan evidence of instability with possible MRI evidence of ligamentous integrity
was not feasible given the limitations of the available data. This may be a fertile avenue of
future investigation, however. Based on the results of the present study, it is reasonable
that for the patient with persistent symptoms of upper cervical instability and a positive
(i.e., Grade 2+) A-ART, that the next step in evaluating the source of the ongoing symptoms
would include both a cervical MRI and the CT scan of upper cervical rotation.
Prior investigations of upper cervical ligamentous injury have largely focused on non-
dynamic imaging of morphological changes in the upper cervical ligaments, with particular
focus on the alar and transverse ligaments, with the head in a neutral position [11,12].
The degree of association between such imaging findings and patient outcomes, if any, is
uncertain, however [13]. Dynamic CT evaluations of the upper cervical spine have been
described in the evaluation of instability secondary to rheumatoid arthritis or healing
odontoid fractures, but few describe the technique for the evaluation of ligamentous
integrity following traumatic injury [14,15]. In one such study, authors used CT scanning to
quantify rotational instability in 47 patients with chronic symptoms after whiplash trauma,
in comparison with 26 uninjured controls, by quantifying the relative segmental rotation at
each level versus total cervical rotation [16]. The authors found excessive rotation at C0-C1
in the injured group, but not at C1-2. In contrast with the present study, however, no prior
research has evaluated residual overlap at C1-2 in an injured population.
There are several potential weaknesses of the present investigation which prompts
caution in interpreting the results: the foremost is that the A-ART evaluation was performed
by two examiners with substantial experience with the test, and thus, the reliability of the
test when performed by other clinicians cannot be established with these results. Further,
there are no established norms for the amount of palpable rotational movement between
C1 and C2 that would fall into the negative (Grade 0–1) versus positive (Grade 2–3) A-ART
result, and the ~5 mm threshold described for the test is an unmeasured approximation.
Additionally, the average and range of values for the residual facet overlap evaluation in
healthy adults was only found in a single prior publication; thus the technique is relatively
novel and has not been validated on a more diverse population. The results of the present
study are the first to describe residual facet overlap in a symptomatic population with a
history of traumatic injury, however.
For patients with rotational instability at C1-2, therapeutic options are minimal, and
results uncertain. Some, but not all of the patients in the current study had positive results
from rehabilitation and physical therapy modalities. For patients with refractory symptoms,

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surgical fusion of C1-C2 is a viable option, although outcomes and complication rates are
not well established.
We cautiously interpret these results to suggest that the atlas-axis rotational test
(A-ART) is a potentially useful physical examination tool for identifying the pathological
source of persisting cervicocranial symptoms consistent with upper cervical rotational
instability. As such, the test offers potential benefits in the medicolegal investigation of
the pain generator in patients with persisting unexplained upper cervicocranial symptoms
after whiplash trauma, in that the patients most likely to have objective imaging evidence of
rotational instability at C1-2 can be identified with greater accuracy, thus providing legally
admissible proof of the location and extent of injury. Further investigation is warranted to
evaluate the practicality and diagnostic accuracy of the A-ART in larger patient populations.

5. Conclusions
An accurate diagnosis can be elusive for the patient with persisting whiplash trauma-
related craniocervical symptoms, in part because injury that results in rotational instability
can be difficult to identify or quantify. The use of the atlas-axis rotational (A-ART) or-
thopedic test may provide reliable evidence for the presence of upper cervical instability,
and should be considered as a useful initial test for differential diagnosis of the source
of persisting head and neck symptoms in patients with chronic pain following whiplash
trauma. For patients with a positive A-ART, an axial CT scan will provide a definitive
diagnosis, as well as quantification, of rotational instability.

Supplementary Materials: The following supporting information can be downloaded at: https:
//www.mdpi.com/article/10.3390/jcm12041469/s1.
Author Contributions: B.R.K., T.J.M., M.H.B. and M.D.F. all participated in the study conception,
design, analysis, and drafting of the manuscript, and all authors have approved the submitted version
of the manuscript and have agreed both to be personally accountable for their own contributions and
to ensure that questions related to the accuracy or integrity of any part of the work are appropriately
investigated, resolved, and the resolution documented in the literature. All authors have read and
agreed to the published version of the manuscript.
Funding: No outside funding was used for the study.
Informed Consent Statement: All of the study subjects consented to the procedures as part of
clinically indicated routine diagnostic procedures. The anonymized retrospective record review
protocol was exempt from ethics review.
Data Availability Statement: The data that served as the source material for the analysis are provided
in a supplemental file.
Conflicts of Interest: M.D.F. provides expert medicolegal consultation. No conflicts are declared for
the remaining authors.

Abbreviations
UCRI—upper cervical instability test; A-ART—atlas-axis rotational test; CT—computed tomography.

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 Journal of
Clinical Medicine

Article
Non-Surgical Management of Upper Cervical Instability via
Improved Cervical Lordosis: A Case Series of Adult Patients
Evan A. Katz 1 , Seana B. Katz 1 and Michael D. Freeman 2, *

1 Independent Researcher, Boulder, CO 80302, USA

2 Faculty of Health Medicine and Life Sciences, Maastricht University, 6229 ER Maastricht, The Netherlands
* Correspondence: [email protected]

Abstract: Injury to the head and neck resulting from whiplash trauma can result in upper cervical
instability (UCIS), in which excessive movement at C1 on C2 is observed radiologically. In some cases
of UCIS there is also a loss of normal cervical lordosis. We postulate that improvement or restoration
of the normal mid to lower cervical lordosis in patients with UCIS can improve the biomechanical
function of the upper cervical spine, and thus potentially improve symptoms and radiographic
findings associated with UCIS. Nine patients with both radiographically confirmed UCIS and loss of
cervical lordosis underwent a chiropractic treatment regimen directed primarily at the restoration
of the normal cervical lordotic curve. In all nine cases, significant improvements in radiographic
indicators of both cervical lordosis and UCIS were observed, along with symptomatic and functional
improvement. Statistical analysis of the radiographic data revealed a significant correlation (R2 = 0.46,
p = 0.04) between improved cervical lordosis and reduction in measurable instability, determined
by C1 lateral mass overhang on C2 with lateral flexion. These observations suggest that enhancing
cervical lordosis can contribute to improvement in signs and symptoms of upper cervical instability
secondary to traumatic injury.

Keywords: cervical lordosis; motor vehicle crash; digital motion X-ray; upper cervical instability

Citation: Katz, E.A.; Katz, S.B.;

Freeman, M.D. Non-Surgical
Management of Upper Cervical
1. Introduction
Instability via Improved Cervical Whiplash is an injury mechanism most typically associated with the rapid flex-
Lordosis: A Case Series of Adult ion/extension, compression and rotation of the cervical spine that can occur in a motor-
Patients. J. Clin. Med. 2023, 12, 1797. vehicle crash [1]. Injuries resulting from whiplash trauma are common; it is estimated
https://doi.org/10.3390/ that there are approximately 2.9 million cases of whiplash trauma-associated injury that
jcm12051797 occur annually in the US [2]. The constellation of chronic symptoms, largely affecting
Academic Editors: Deed Harrison,
the head and neck, that can result from acute injury after whiplash trauma can present
Ibrahim Moustafa and Paul Oakley a complex problem for both patients and clinicians [3]. Chronic symptoms associated with
“late whiplash” can include headaches, dizziness, neck and upper back pain, as well as
Received: 19 January 2023 widespread pain [4]. Cervical spine pathology associated with whiplash trauma includes
Revised: 16 February 2023
facet derangement, disk injury, and spinal ligament strain and rupture, often in the upper
Accepted: 20 February 2023
cervical spine [5].
Published: 23 February 2023
Whiplash trauma can also result in upper cervical instability (UCIS), a condition in
which excessive movement is observed at the C1–2 levels in combination with a wide
constellation of head and neck somatic signs and symptoms [6,7].
Copyright: © 2023 by the authors.
UCIS is typically identified and diagnosed by comparing radiographic findings in
Licensee MDPI, Basel, Switzerland. patients with clinical complaints to accepted normal radiographic values (Figure 1). Ra-
This article is an open access article diographic evidence of UCIS includes anterior translation of C1 on C2 such that the
distributed under the terms and atlanto-dental interspace exceeds 3.5 mm (as observed on lateral flexion radiographs), [8]
conditions of the Creative Commons and lateral translation of C1 on C2 such that there is more than 2.0 mm of lateral overhang
Attribution (CC BY) license (https:// of the lateral mass of C1 on the superior articulating facet of C2 (as observed in anterior to
creativecommons.org/licenses/by/ posterior (AP) open-mouth radiographs with lateral bending movements), in combination
4.0/).

J. Clin. Med. 2023, 12, 1797. https://doi.org/10.3390/jcm12051797 https://www.mdpi.com/journal/jcm

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with asymmetry of the peri-odontoid space. While the 2.0 mm overhang threshold has only
moderate sensitivity and positive predictive value (PPV) for upper cervical injury in the
whiplash-injured population with chronic symptoms (64% and 75%, respectively), and the
more subjective asymmetry assessment has low sensitivity (29%) but high PPV (95%), in
combination the two findings have a PPV of 100% [9].

(a)

(b)

Figure 1. (a) Actual rotational angles (ARA) measurement in a patient with a normal cervical lordosis.
The ARA (in red) indicates the angle between the posterior body margins of C2 (solid white line) and
C7 (dashed white line). (b) AP open mouth lateral bending still shots from the DMX study (left and
right lateral flexion on the left and right, respectively), with the green line indicating the lateral mass
margin of C1, and the red line indicating the lateral body margin of C2. The lines overlap, indicating
no overhang of C1 on C2.

The presence of instability is generally assumed to result from ligamentous and facet
capsule damage resulting from the incipient trauma [10]. The loss of ligamentous integrity
in the upper cervical spine in turn raises the concern of increased risk of future injury in
the unfortunate event of a subsequent trauma [11]. Patients with symptomatic UCIS may
complain of symptoms with varying degrees of specificity to the pathology—ranging from
seemingly high specificity (i.e., difficulty holding the head up without support, intolerance

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to prolonged static postures, persisting sensation of suboccipital clicking) to nonspecific

(i.e., head, neck, and shoulder pain) [12,13].
For UCIS patients with refractory symptoms, surgical fusion of the C1–C2 vertebrae is
a viable, albeit under-investigated therapeutic option, as success and complication rates for
the relatively rare procedure are not reliably established in the literature. Like all spinal
fusion surgeries, fusion for C1–2 instability is expensive, invasive, and carries some degree
of risk [14]. In addition to the immediate risks associated with surgery such as blood loss
and neurological injury, intermediate (i.e., infection, graft subsidence) and long-term risks
(adjacent segment pathology) are also potential complications of spinal fusion surgery [15].
In spite of the risks, upper cervical fusion is often the only option presented to the patient
with refractory symptoms and demonstrable UCIS.
Loss of the normal cervical lordotic curve is a common radiographic finding in patients
with chronic pain after whiplash [16], although there is no general consensus in the literature
as to whether the finding indicates true pathology or a normal variant [17–20]. It is well
established, however, that the normal cervical lordosis is the biomechanically ideal posture
of the cervical spine, as mechanical stresses in the spine are most evenly balanced between
the intervertebral disk and zygapophyseal joints when the “C”-shaped curve of the neck is
maintained [21]. The clinical benefits of a lordotic cervical curve have been demonstrated
in multiple studies. As an example, in a study of 300 neck pain patients under the age of
40, Gao and colleagues found an increased degree of disk herniation in the patients with
straight and kyphotic cervical spines, in comparison with the lordotic necks [22]. They also
reported an improvement in disk height and a decrease in disk herniation severity and
associated spinal cord compression in the patients who had an improvement in lordosis.
A recent systematic review of controlled clinical trials of lordosis restoration therapy for
neck pain patients demonstrated that when treatment included extension traction directed
at improvement of the lordotic curve, symptomatic improvements were maintained for
more than 1 year after cessation of therapy [23]. In comparison, control treatment groups
without extension traction were more likely to relapse after cessation of therapy.
A therapeutic model directed at methods of restoring the normal cervical curve is
called Chiropractic BiophysicsTM (CBP). CBP relies on a combination of common chiroprac-
tic modalities (e.g., manipulation), Mirror Image® exercises, and spinal extension traction
(Figure 2) [24]. There is evidence that suggests that CBP therapy is effective for restoring
cervical lordosis [25].
While it is the mid to lower cervical spine that benefits most from the restoration
of normal lordosis, there is evidence that the upper cervical spine can also benefit from
a normal cervical curve, as a straight or kyphotic cervical spine is compensated at the
C0–1–2 level by excessive craniocervical extension in an effort to keep the eyes level with
the horizon [26,27].
In the present investigation, we describe nine cases of radiographically confirmed and
symptomatically congruent UCIS in patients with chronic symptoms following whiplash
trauma. In all nine cases, the patients were also found to have a reduction in normal
cervical lordosis, and thus treatment was directed at restoring the lordotic curve via the
CBP® approach. Baseline and post-treatment radiographic parameters of both UCIS and
cervical lordosis are described, as well as subjective response to treatment.

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J. Clin. Med. 2023, 12, 1797

(a)

(b) (c)
Figure 2. (a) Cervical posture pump® demonstration. (b) Denneroll™ demonstration. (c) 2-way
extension traction demonstration. Note: the model in all figures is author EAK.

2. Materials and Methods

This case series includes nine patients (2 male, 7 female), ranging in age from 28 to
52 years with an average age of 39 years (Table 1). Each patient presented to the same
chiropractic practice (authors EK and SK) for evaluation of acute or chronic symptoms
consistent with upper cervical instability. The majority of the patients had undergone
evaluation with other clinicians, including neurosurgeons or orthopedic spine surgeons,
or had been previously treated with physical therapy or chiropractic manipulation. The
inclusion criterion for the cases was all consecutive patients presenting with radiographic
evidence of both UCIS and loss of cervical lordosis, following a history of traumatic injury
of the neck (primarily whiplash trauma). A finding of fracture, dislocation, or myelopathy
or other concerning neurological manifestation of the instability was an exclusion criterion,
as such patients would be uniformly referred for urgent neurosurgical or orthopedic
evaluation as part of the clinic protocol. The patient histories and treatment course varied
widely, and the median time between baseline and follow-up radiographic examination
was 16 weeks (with an interquartile range of 32 weeks).

Table 1. Patient characteristics.

Patient Gender Duration a

Age Symptoms b
Number (M/F) (Weeks)
1 F 46 7 Neck pain and weakness, dizziness.
2 F 36 10 Neck pain, headaches.
Pain at the base of the skull, clicking
3 M 37 12
sensation dizziness.
4 F 52 16 Head and neck pain, blurred vision.
Head and neck pain, blurred vision, arm
5 F 34 16
tingling, clicking sensation, sleep disruption.
Head and neck pain, occipital spasms,
6 M 28 19
blurred vision, dizziness.

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Table 1. Cont.

Patient Gender Duration a

Age Symptoms b
Number (M/F) (Weeks)
7 F 35 44 Head and neck pain, arm tingling.
Head and neck pain, head pressure, pain
8 F 53 52
behind left eye, sleep disruption
9 F 30 68 Debilitating Headaches, neck pain.
a Duration indicates the period of time between baseline radiographic measurement and follow-up evaluation.
b Symptoms listed are only those consistent with UCIS. Patients may have had other less UCIS-specific symptoms.

2.1. Radiographic Analysis

Video-Fluoroscopic (VF) examination of the cervical spine was performed using digital
motion X-ray (DMX). This imaging protocol allows for continuous examination of move-
ment within the cervical spine. DMX records 30 images per second of continuous X-ray and
captures an active range of motion allowing dynamic four-dimensional visualization of the
integrity of the ligaments of the upper cervical spine. DMX imaging, therefore, provides the
opportunity to assess both static and dynamic parameters of vertebral alignment [28,29].
Two DMX views were used to assess the degree of lordotic curvature and to identify
and quantify findings consistent with UCIS; a neutral lateral cervical (NLC) and anterior
to posterior open-mouth lateral cervical bending (APOM-LCB). Both examinations were
performed at the baseline and prior to initiation of therapy, and then repeated no less than
72 h after therapy was concluded, as the goal was to avoid imaging of any temporary
cervical curve improvement directly following extension traction. In order to produce
images that were consistent with each other, the patient was positioned in the same fashion
in both studies, each conducted by the same author, (either EAK or SBK), with the central
ray at C5, back or shoulder touching the image intensifier (depending on view), and with
a 20 mm marker on the patient’s skin for calibration of the PostureRay® measuring software.
Actual Rotational Angles (ARA) were calculated from sagittal NLC images using
PostureRay® software (PostureCo, Inc., Trinity, FL, USA) for Computerized Radiographic
Mensuration Analysis (see Figure 1a). The cervical ARA is the angular measurement
between the posterior vertebral body margins of C2 and C7, and the average ARA for
a maintained cervical lordosis is −34◦ [30]. All images include a standard X-ray marker for
calibration prior to each measurement in order to avoid magnification error.
The ARA was used to quantify the deviation of the segmental rotational angles from
C2–C7 from normal cervical lordosis values. Static images of right and left APOM-LCB
were taken as frames from DMX videos at the extremes of comfortable lateral flexion. The
images were analyzed using the PostureRay® software to quantify the amount of C1–C2
lateral mass overhang margin at maximum right and left lateral cervical bending (Figure 1b).
An overhang margin of >3 mm was used as the threshold for the study inclusion criterion
of potential C1 on C2 instability, in combination with asymmetry of the peri-odontoid space.
As noted above, at this threshold of combined findings, the sensitivity (i.e., true positive
rate) and positive predictive value (i.e., true positive rate/all positives) for traumatic injury
is 100% [9].
Along with findings consistent with UCIS, included patients also demonstrated a loss
of lordosis, defined as an increase from the average normal lordotic ARA of −34◦ (see
Table 2), resulting in an appearance of straightening or reversal (i.e., kyphosis) of the normal
lordotic curve. Combined with an initial evaluation indicating symptomatic instability, the
radiological examination confirmed a diagnosis of both loss of normal cervical lordosis and
upper cervical instability for each of the nine patients included for study, as well as some
degree of presumed injury to the upper cervical ligaments, including the alar, transverse,
and other stabilizing ligaments [31].

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Table 2. Radiographic measurements, pre and post intervention.

Time of X-ray, Relative ARA b C1–2 Lateral Overhang Margin c

to Intervention a C2–C7 Left Right
Patient 1 Baseline −14.1◦ 8.8 mm 6.1 mm
Post intervention −30.4◦ 6.3 mm 2.1 mm
Patient 2 Baseline −4.1◦ 7.5 mm 1.8 mm
Post intervention −23.6◦ 2.3 mm 1.6 mm
Patient 3 Baseline −2.8◦ 5.2 mm 2.4 mm
Post Intervention −4.6◦ 1.3 mm 1.8 mm
Patient 4 Baseline 3.0◦ 3.6 mm 1.2 mm
Post intervention −17.9◦ 1.1 mm 0.5 mm
Patient 5 Baseline −8.8◦ 8.8 mm 6.1 mm
Post intervention −18.2◦ 6.3 mm 2.1 mm
Patient 6 Baseline −19.9◦ 3.2 mm 3.0 mm
Post intervention −29.6◦ 2.2 mm 0.5 mm
Patient 7 Baseline −11.2◦ 7.0 mm 1.9 mm
Post intervention −17.0◦ 2.5 mm 1.2 mm
Patient 8 Baseline −12.0◦ 5.5 mm 3.5 mm
Post intervention −14.8◦ 2.8 mm 2.9 mm
Patient 9 Baseline −19.7◦ 4.6 mm 2.0 mm
Post intervention −29.0◦ 2.0 mm 1.3 mm
a During the period of time between the first and follow-up X-rays (the ‘treatment duration’), patients underwent
treatment according to the intervention protocol. b ARA: Absolute Rotational Angle. Normal value is −34.0◦ or
less. c Normal value 2 mm or less.

2.2. Intervention
Patients were treated twice per week on average for the indicated durations of treat-
ment between radiographic evaluations (Table 1). Treatments incorporated full spine
chiropractic adjustments, as well as Mirror Image® adjustments using a drop-piece table.
Mirror Image® adjustments involve placing the cervical spine into an extended, overcor-
rected position during the chiropractic adjustment in order to achieve optimal progression
toward proper spinal alignment [32]. The manipulations were solely directed at hypomo-
bile spinal segments in the mid and lower cervical spine, as manipulation at the unstable
upper cervical spine would be contraindicated. Several forms of cervical extension traction
to restore or improve the cervical lordosis were also administered. These consisted of
the following:
(1) Use of a Cervical posture pump® (Posture Pro, Inc., Huntington Beach, CA, USA),
a self-controlled device with an inflatable airbladder that is applied to the supine
mid-cervical spine. See Figure 2a.
(2) Home use of a cervical Denneroll™ (Denneroll Industries International Pty Ltd.,
Sydney, Australia), used like a pillow while the patient is supine, and positioned at
the mid to lower cervical spine. See Figure 2b.
(3) Once tolerance to the previous two devices was established, the patient was pro-
gressed into a form of 2-way extension traction performed in office [33]. This therapy
is applied while the patient lies supine on a specially designed chair, that employs
a forehead harness to fix the head in a slightly extended position. A second strap is
used to apply anterior tension to the mid to lower cervical spine, along the plane of
the mid cervical spinal disks. See Figure 2c.

2.3. Statistical Analysis

Average treatment effect was assessed via the difference between the pre- and post-
treatment radiographic measurements of ARA and lateral mass overhang using the Stu-
dent’s t-test for normally distributed differences and the signed rank test for non-normally
distributed differences. Linear regression was used to assess the correlation between the
percent change in ARA and the average of the left and right percent changes in C1–C2
overhang measurement (percent change = [post-measurement − pre-measurement]/pre-

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measurement; average overhang percent change = [left percent change + right percent
change]/2). Normality of each difference and the average overhang percent change was as-
sessed using the Shapiro-Wilk test. p-values < 0.05 were considered significant. All analyses
were performed using SAS Software, version 9.4 (SAS Institute, Inc., Cary, NC, USA).

3. Results
Following the intervention period, clinical evaluations and radiographic analyses
of each patient were repeated. After the intervention, each patient described marked
improvements in overall pain scores, cervical range of motion, and quality of life. Patients
who reported symptoms most closely associated with UCIS, including dizziness and
blurred vision (patients one, two, five, and six), reported cessation that they are no longer
experiencing those symptoms as of the end of this study. Additionally, those patients who
had been managing their pain with prescription pain medications were no longer doing so.
Furthermore, each patient described in this report has been able to resume activities which
had been precluded by their neck pain and symptoms relating to instability. Patient three
was able to resume participation in martial arts, and patients four and five also reported
improved function. Patients seven, eight and nine reported a decrease or cessation of
chronic and frequent headaches.
Radiographic re-evaluations, performed at least 72 h after the most recent therapy,
revealed substantially improved cervical lordosis (i.e., progress toward the ideal ARA of
−34◦ ) in all of the patients. Mean ARA value at baseline was −10◦ , compared to −21◦ after
the intervention (p = 0.002, see Table 3). Three of the patients (one, six, and nine) had ARA
values at or approaching −30◦ (see Table 2). There was an average reduction in C1–C2
lateral mass overhang from 6.0 mm to 3.0 mm on the left (p = <0.001), and from 3.1 mm to
1.6 mm on the right (p = 0.004) (see Table 3). The average percent change in C1–2 overhang
was normally distributed (p = 0.91). The percent change in ARA and average percent
change in C1–2 overhang were moderately correlated (see Figure 3, R2 = 0.46, p = 0.04).

Table 3. Differences between post- and pre-treatment measurements (negative values

denote improvement).

Patient ARA Left Overhang Right Overhang

1 −16.3 −2.5 −4.0
2 −19.5 −5.2 −0.2
3 −1.8 −3.9 −0.6
4 −20.9 −2.5 −0.7
5 −9.4 −2.5 −4.0
6 −9.7 −1.0 −2.5
7 −5.8 −4.5 −0.7
8 −2.8 −2.7 −0.6
9 −9.3 −2.6 −0.7
Shapiro-Wilk test of normality
0.4 0.29 0.004
p-value a
Mean difference (standard deviation) −10.6 (6.9) −3.0 (1.27) −1.6 (1.5)
Mean difference 95% CI [−15.9, −5.3] [−4.0, −2.1] [−2.7, −0.4]
Test statistic b −4.6 −7.2 −22.5
Degrees of freedom (df) 8 8 NA
p-value 0.0018 <0.0001 0.0039
aFor sample sizes < 2000, Shapiro-Wilk is the appropriate test of normality. b Paired t-test for ARA and left
overhang; signed rank test for right overhang.

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Figure 3. Linear regression analysis of average % change in C1-2 overhang versus the % change
in ARA.

4. Discussion
There are several plausible explanations for the observed association between symp-
tomatic improvement, improved cervical lordosis, and decreased C1–2 instability in the
described cases. One explanation is that the symptoms resolved spontaneously, and that
the improvements were unrelated to the treatment or radiographic changes. While plau-
sible, this explanation defies logic and convention. The patients had been symptomatic
for months to years and had all tried other treatments without success prior to initiating
the cervical lordosis correction therapy. The positive changes observed in the imaging are
thus much more likely to be explained by the therapy, rather than the natural course of the
condition, which had reached a static level in all of the patients.
The remaining explanations are that the therapy directed at improving cervical lordosis
improved the lordosis, the symptoms, and the C1–2 instability, or that the symptoms and
instability improved for some reason unrelated to the alteration of the lordosis. We favor
the former explanation. The upper cervical instability (and associated symptoms indicative
of UCIS) is the result of upper cervical ligament injury and associated laxity. Loss of
normal cervical lordosis produces a relatively flexed posture of the upper cervical spine,
requiring extension accommodation at the head to keep the neutral gaze level with the
horizon [34,35]. It makes sense that a persistently abnormal posture of the upper cervical
spine would likely put a higher degree of strain on the upper cervical ligaments during
normal activity, relative to having the head in a neutral position relative to C1–2, as occurs
with normal extension at the craniocervical junction. We hypothesize that improvement
of the cervical lordosis results in improved biomechanics of the upper cervical spine, and
that this in turn allows for improvement of the integrity of the ligaments responsible for
craniocervical stability. This hypothesis is an extension of the findings of prior authors,
who have described a correlation between increased angle of the upper cervical (C0–2)
spine and increased risk of cervical kyphosis [27]. Ours is the first study to demonstrate
a relationship between loss of normal cervical curve and symptomatic instability, however.
Because the design of the present study was conceived of only after the association be-
tween cervical curve improvement and decreased upper cervical instability was noted, the
evidence for symptomatic improvement was derived from narrative histories, rather than
consistently used metrics. Future investigation would thus benefit from an a priori design
with standardized objective measurements of the non-radiographic changes described in

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this study (e.g., Neck Disability Index, etc.), as well as the inclusion of a comparison group
of patients who did not improve radiographically in either cervical curve or upper cervical
instability. Moreover, the ability to generalize from this small sample of highly selected
patients is limited, and thus another goal for future investigation is to increase the number
of study subjects.

Author Contributions: Conceptualization, E.A.K., S.B.K. and M.D.F.; methodology, E.A.K., S.B.K.
and M.D.F.; formal analysis, M.D.F.; investigation, E.A.K., S.B.K. and M.D.F.; resources, E.A.K. and
S.B.K.; writing—original draft preparation, M.D.F.; writing—review and editing, E.A.K., S.B.K. and
M.D.F. All authors have read and agreed to the published version of the manuscript.
Funding: This research received no external funding.
Informed Consent Statement: Informed consent was obtained from all subjects involved in the
study. As the data were gathered retrospectively from anonymized files of patients who were treated
under standard clinical protocol, the study was exempt from institutional review board oversight.
Data Availability Statement: All data were provided in the manuscript.
Acknowledgments: The authors thank Wendy Leith MPH MS for assistance with the data analysis,
and Deed Harrison for his many helpful suggestions and encouragement.
Conflicts of Interest: The authors declare no conflict of interest.

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