Low-energy extracorporeal shock-wave

treatment (ESWT) for tendinitis of the

supraspinatus
A PROSPECTIVE, RANDOMISED STUDY
J. Schmitt, M. Haake, A. Tosch, R. Hildebrand, B. Deike, P. Griss
From Philipps-University, Marburg, Germany

e have performed a controlled, randomised to non-operative treatment. In such cases, acromioplasty

W study to analyse the effects of low-energy
shock-wave therapy (ESWT) on function and pain in
may be performed as an open or arthroscopic procedure. As
a therapeutic option for patients with chronic tendinitis of
tendinitis of the supraspinatus without calcification. supraspinatus low-energy shock-wave treatment (ESWT)
3-11
There were 20 patients in the treatment group and 20 has been recommended; 1000 to 2000 shock waves of
2
in the control group. The former group received 6000 an energy flux density (ED) from 0.01 to 0.4 mJ/mm are
2 9
impulses (energy flux density, 0.11 mJ/mm ) in three usually applied two to three times at weekly intervals. The
sessions after local anaesthesia. The control group had analgesic effect of ESWT was first described by Dahmen et
10
6000 impulses of sham ESWT after local anaesthesia. al. It has given relief of pain in 50% to 80% of patients
The patients were examined at six and 12 weeks with improvement in function depending on the site of the
11,12
after treatment by an independent observer who lesion. Despite the fact that there is as yet no definite
evaluated the Constant score and level of pain. We proof of the effectiveness of ESWT the number of patients
found an increase in function and a reduction of pain receiving treatment in Germany each year is estimated to
in both groups (p ≤ 0.001). Statistical analysis showed be 60 000 to 100 000, which is more than the number of
no difference between the groups for the Constant patients receiving lithotripsy for urological conditions. The
score and for pain. We therefore do not recommend electrophysiological pathways and molecular mechanisms
13
ESWT for the treatment of tendinitis of of the antinociceptive effect of ESWT are still unknown
supraspinatus. and a matter of speculation. Previously published studies of
J Bone Joint Surg [Br] 2001;83-B:873-6.
the use of ESWT in the treatment of tendinitis of the
Received 2 August 2000; Accepted 13 December 2000 supraspinatus have methodological and statistical flaws,
such as uncontrolled design, no inclusion/exclusion criteria
and no record of previous treatments. As a result ESWT is
Tendinitis of the supraspinatus is a common cause of pain no longer recognised for insurance reimbursement,
1,2
in the shoulder. The symptoms include tenderness at the although it has become a well-known alternative to oper-
insertion of the tendon of supraspinatus and pain on abduc- ative techniques. We have therefore carried out a pro-
tion and extension against resistance. A tear of the rotator spective, randomised placebo-controlled, single-blind study
cuff and osteoarthritis of the acromioclavicular joint must to examine the effect of ESWT, and compared it with
be excluded by clinical examination, radiography and ultra- placebo treatment to create a basis for the planning of a
sound or MRI. In contrast to calcifying tendinitis radio- larger trial.
graphs of the shoulder show no abnormality. The condition
is usually treated by physiotherapy, analgesics and sub- Patients and Methods
2
acromial injection of steroids and local anaesthetic. In
some cases acute tendinitis becomes chronic and is resistant Inclusion and exclusion criteria were defined as shown in
Table I. The clinician checked eligibility and obtained
signed informed consent before the randomisation. Before
J. Schmitt, MD Resident consenting, the patient was informed orally and was given
M. Haake, MD, Clinical and Research Fellow an information sheet. Between March 1999 and February
A. Tosch, Postgraduate Student
R. Hildebrand, MD, Resident 2000, 40 patients were included in the study and randomly
B. Deike, Resident assigned to each group. There were 20 men and 20 women
P. Griss, Professor and Chairman
Department of Orthopaedics, Philipps-University of Marburg, Baldinger- with a mean age of 52 years (29 to 66). In 23 the right
strasse, D-35033 Marburg, Germany. shoulder was affected, and in the other 17 the left. All
Correspondence should be sent to Dr J. Schmitt. patients in the treatment group received extracorporeal
©2001 British Editorial Society of Bone and Joint Surgery shock waves in three sessions at intervals of one week,
0301-620X/01/611591 $2.00 using the shock-wave generator Storz Minilith SL 1 (Storz
VOL. 83-B, NO. 6, AUGUST 2001 873
874 J. SCHMITT, M. HAAKE, A. TOSCH, R. HILDEBRAND, B. DEIKE, P. GRISS

Table I. Inclusion and exclusion criteria

Inclusion criteria Exclusion criteria
Clinical diagnosis of chronic tendinitis Glenohumeral or acromioclavicular
of supraspinatus arthritis
Absence of calcification Tear of the rotator cuff
Duration of symptoms for at least six months Allergy to mepivacaine
Failed conservative treatment Former operations to the treated shoulder
Minimum of 10 sessions of physiotherapy Local tumours or infections
At least two subacromial injections
Intake of NSAIDs Age below 18 years
No treatment in the last four weeks
Free range of movement or at least Neurological disorders
abduction of 90° and free rotation Acute bursitis of the shoulder

Medical AG, Kreuzlingen, Switzerland) (Fig. 1a), applying treat basis. No prospective cessation rules were defined.
2
2000 impulses of an ED+ of 0.11 mJ/mm measured by a Assignment. After each patient entered the study, a hotline
2
PVDF-Hydrophone, equivalent to 0.33 mJ/mm measured (Institut für Medizinische Biometrie und Epidemiologie)
by a fibreoptic-hydrophone, at 120 impulses per minute was called and the patient was assigned to a treatment
with ultrasound localisation to the insertion of the supra- group using random permutated blocks. The group allo-
spinatus tendon (Fig. 1b). Patients in the control group cated to the patient was written on the treatment protocol
were treated by sham ESWT under the same conditions as which was separated from the evaluation sheet used by the
the treatment group. independent observer, who was neither involved in the
All patients were evaluated using a questionnaire before treatment nor knew to which group the patient had been
14
randomisation. This included the Constant and Murley assigned.
score, and assessment of pain on a visual analogue scale Masking. As the shock waves may cause pain, patients in
from 0 (no pain) to 10 (maximum pain) during activity and both groups were given 10 ml of mepivacaine as sub-
at rest. Rupture of the rotator cuff was diagnosed either by acromial local anaesthesia. In the placebo group a foil was
ultrasound or MRI. The patients were reassessed by an placed between the patients and the water cushion to
independent observer using the same questionnaire at 6 and prevent the shock wave from reaching them. The typical
12 weeks after the treatment. The primary outcome of the sound created by the ESWT machine was present for both.
study was the rate of success 12 weeks after the last Only the physicians operating the machinery knew the
treatment, with success being defined by the increase in the group to which each patient belonged, and they were not
age-corrected Constant score of at least 30 points or an involved in further stages of the study.
absolute score of 80% of the normal value. Such an out-
come is considered to be clinically significant. Because of Results
the lack of previous data, no other important differences
could be defined. The target sample size was projected by The mean Constant score before treatment was 34 (17 to
an estimated duration of the treatment phase of one year. 63). The mean score for pain at rest was 5 (1 to 10) and for
Comparative analyses were completed on an intention-to- that during activity 8 (4 to 10). One patient in the control

Fig. 1a Fig. 1b
Figure 1a – Photograph showing the positioning of the patient and ESWT applicator. Figure 1b – Ultrasonogram to target the shock wave. The cross-hair
indicates the focus of the acoustic lens aimed at the insertion of the tendon of supraspinatus (S) into the greater tuberosity (T).

THE JOURNAL OF BONE AND JOINT SURGERY

 LOW-ENERGY EXTRACORPOREAL SHOCK-WAVE TREATMENT (ESWT) FOR TENDINITIS OF THE SUPRASPINATUS 875

Table II. Mean (± SD) values for parameters before and at six and 12 weeks after treatment comparing the control
and treatment groups. In all parameters the differences between both groups are not significant (p > 0.05)
Treatment 95% CI
Group/parameter Control group group (group difference)
Constant score (age-corrected)
Pretreatment 42.20 ± 13.04 (n = 20) 40.70 ± 13.29 (n = 20) -6.93 to 9.93
At 6 weeks 64.17 ± 25.17 (n = 18) 60.95 ± 29.62 (n = 19) -15.17 to 21.61
At 12 weeks 64.39 ± 32.68 (n = 18) 66.50 ± 37.92 (n = 20) -25.53 to 21.31
Number of successful treatments 8 (n = 18) 10 (n = 20) N/A
Subjective improvement (%)
At 6 weeks 26.32 ± 28.67 (n = 19) 28.42 ± 32.02 (n = 19) -22.10 to 17.89
At 12 weeks 31.05 ± 31.43 (n = 19) 40.00 ± 38.35 (n = 20) 31.77 to 13.87
Pain during rest (VAS 0 to 10)
Pretreatment 5.40 ± 3.00 (n = 20) 5.35 ± 2.54 (n = 20) -1.73 to 1.83
At 6 weeks 2.78 ± 2.71 (n = 18) 2.74 ± 3.03 (n = 19) -1.88 to 1.97
At 12 weeks 3.22 ± 2.82 (n = 18) 2.30 ± 3.03 (n = 20) -1.01 to 2.85
Pain during activity (VAS 0 to 10)
Pretreatment 7.95 ± 1.96 (n = 20) 7.75 ± 1.48 (n = 20) -0.91 to 1.31
At 6 weeks 5.72 ± 2.80 (n = 18) 5.74 ± 2.51 (n = 19) -1.79 to 1.76
At 12 weeks 6.11 ± 3.23 (n = 18) 4.85 ± 3.07 (n = 20) -0.81 to 3.33

group did not return after the initial visit. The other 39
received the treatment as randomised.
No significant side-effects were seen during or after
treatment. At follow-up at six and 12 weeks, 19 of the
treatment group and 18 of the control group returned for
examination. Sixteen patients were not satisfied with the
results of their treatment. They were demasked and
informed as to which group they belonged. The patients in
the control group were offered the real ESWT treatment
while those in the treatment group were informed about
further options. There were no deviations from the study
protocol.
We used SPSS 9.0 (SPSS Inc, Chicago, Illinois) for the
statistical analysis of the results. For differences between
the treatment and the control groups we used the t-test for
non-paired samples (p ≤ 0.05). Before using the t-test, a test
for the normal distribution of the data and equal variances
Fig. 2 was performed and 95% confidence intervals were calcu-
lated for the differences between both groups. No sig-
Graph showing the 95% confidence interval (CT) of the 12-week age-
adjusted Constant score showing the small difference between the control nificant differences were found between the controls and
and the treatment group. The solid lines are the initial scores in both those treated (Table II). Figure 2 shows a plot of the 95%
groups. The dashed lines show the 12-week scores.
confidence interval of the 12-week Constant scores for both
groups. In addition, a t-test for paired samples was used to
Table III. Mean (± SD) and 95% confidence interval (CI) of the difference analyse the effect of the treatment as a whole regardless of
between the Constant score and the pain (VAS) during rest and during the group (p ≤ 0.001). There was a highly significant
activity, before and after treatment, based on all patients at follow-up at 12
weeks (n = 38). All differences are highly significant (p ≤ 0.001)
improvement in the Constant score (age-corrected) and
Difference pre- v 95% CI
pain at rest and during activity (Table III). A power analysis
Parameter (n = 38) post-treatment (difference was performed for the 12-week Constant score (age-cor-
15
Constant score (age-corrected) rected) using the program Gpower. The post-hoc analysis
12 weeks – pretreatment 17.61 ± 27.17 26.54 to 8.67 gave a power of 5.37% to detect the effect of ESWT with
Pain during rest (VAS 0 to 10) subacromial injection of mepivacaine as against injection
12 weeks – pretreatment -2.42 ± 3.58 -1.24 to -3.60 only. An a priori analysis gave a total sample size of
Pain during activity (VAS 0 to 10) 16 818 patients for a given power of 95% needed to prove
12 weeks – pretreatment -2.39 ± 3.54 -1.23 to -3.56
the effect.
VOL. 83-B, NO. 6, AUGUST 2001
876 J. SCHMITT, M. HAAKE, A. TOSCH, R. HILDEBRAND, B. DEIKE, P. GRISS

Discussion found in our study cannot realistically be achieved, even

with multicentre trials. Indeed, such a study would not
Our aim was to examine critically the effect of ESWT in seem to be worthwhile. Based on our results, the use of
the treatment of tendinitis of the supraspinatus. Previous low-energy ESWT in the treatment of tendinitis of the
7,10
uncontrolled studies have suggested that this treatment supraspinatus is time-consuming, expensive and probably
is effective. Our findings show a statistically significant ineffective compared with subacromial injections.
improvement (p < 0.001) in both the treatment and the We wish to thank Inke Böddeker for her help with the statistical analysis
control groups as determined by the Constant score and a and Dr Helen Steele for critical reading of the manuscript.
No benefits in any form have been received or will be received from a
pain scale. No statistically significant differences between commercial party related directly or indirectly to the subject of this
the groups were found at follow-up at six and 12 weeks. article.
Our study is the first controlled study of ESWT for this
10
condition. Dahmen et al reported six patients treated by References
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