21 - Ondas-Choque-Cicatriz-Hipertrofica
21 - Ondas-Choque-Cicatriz-Hipertrofica
research-article2020
SBH0010.1177/2059513120975624Scars, Burns & HealingMoortgat et al.
Original Article
controlled trial
Peter Moortgat1 , Mieke Anthonissen1,2, Ulrike Van Daele1,3,
Tine Vanhullebusch1,3, Koen Maertens1,4, Lieve De Cuyper1,5,
Cynthia Lafaire1,5 and Jill Meirte1,6
Abstract
Introduction: A wide variety of non-invasive treatments has been proposed for the management of hypertrophic
burn scars. Unfortunately, the reported efficacy has not been consistent, and especially in the first three
months after wound closure, fragility of the scarred skin limits the treatment options. Extracorporeal shock
wave therapy (ESWT) is a new non-invasive type of mechanotherapy to treat wounds and scars. The aim of the
present study was to examine the objective and subjective scar-related effects of ESWT on burn scars in the
early remodelling phase.
Material and methods: Evaluations included the Patient and Observer Scar Assessment Scale (POSAS) for scar
quality, tri-stimulus colorimetry for redness, tewametry for trans-epidermal water loss (TEWL) and cutometry
for elasticity. Patients were randomly assigned to one of two groups, the low-energy intervention group or
the placebo control group, and were tested at baseline, after one, three and six months. All patients were
treated with pressure garments, silicone and moisturisers. Both groups received the ESWT treatment (real or
placebo) once a week for 10 weeks.
Results: Results for 20 patients in each group after six months are presented. The objective assessments showed
a statistically significant effect of ESWT compared with placebo on elasticity (P = 0.011, η2P=0.107) but
revealed no significant effects on redness and TEWL. Results of the clinical assessments showed no significant
interactions between intervention and time for the POSAS Patient and Observer scores.
Conclusion: ESWT can give added value to the non-invasive treatment of hypertrophic scars, more specifically to
improve elasticity when the treatment was already started in the first three months after wound closure.
Keywords
Extracorporeal shock wave therapy, hypertrophic scar, mechanotransduction, elasticity, low-energy shock waves,
non-invasive treatment, scar management
Corresponding author:
Peter Moortgat, OSCARE, Van Roiestraat 18, Antwerp, B-2170, Belgium.
Email: [email protected]
Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-
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Lay Summary
Pathological scarring is a common problem after a burn injury. A wide variety of non-invasive treatments
has been proposed for the management of these scars. Unfortunately, the reported efficacy of these
interventions has not been consistent, and especially in the first three months after wound closure,
fragility of the scarred skin limits the treatment options. Extracorporeal shock wave therapy (ESWT) is a
relatively new non-invasive therapy to treat both wounds and scars. The aim of the present study was to
examine the scar-related effects of ESWT on burn scars in the early phase of healing.
The scars were subjectively assessed for scar quality by the patient and an observer using the Patient
and Observer Scar Assessment Scale (POSAS). Objective assessments included measurements to assess
redness, water loss and elasticity. Forty patients were randomly assigned to one of two groups, the low-
energy intervention group or the placebo control group (the device simulated the sound of an ESWT
treatment but no real shocks were applied), and were tested at four timepoints up to six months. All
patients were treated with pressure garments, silicone and moisturisers. Both groups received the ESWT
treatment (real or placebo) once a week for 10 weeks.
The objective assessments showed a significant improvement of elasticity in the intervention group when
compared with placebo but revealed no significant effects on redness and water loss. Results of the clinical
assessments showed no differences between the groups for the POSAS Patient and Observer scores.
ESWT can give added value to the non-invasive treatment of pathological scars more specifically to
improve elasticity in the early phase of healing.
ESWT Placebo
Number of patients 20 20
Gender
Men 11 11
Women 9 9
Scar age (months) 2.4 ± 1.4 2.7 ± 1.8 Figure 3. After adjustment for baseline values, a statistically
Scar type significant mean difference of 0.232 mm for elasticity between
the interventions was found after six months in favour of the
Hypertrophy 16 14 intervention group.
Retraction 1 2
Secondary outcomes
Adhesion 3 4
There was no statistically significant interaction
Healing between intervention and time for the individual
items of the POSAS Patient Scale. This indicates
Skin grafted 13 11
that neither group performed better over time.
Spontaneously healed 7 9 For the overall opinion of the POSAS Patient Scale,
a statistically significant difference between the
Values are given as n or mean ± SD. interventions was found after three months (P =
ESWT, extracorporeal shock wave therapy. 0.045) and after six months (P = 0.013). The
results at the different timepoints of all POSAS
Patient scores are presented in Table 2.
Primary outcome There was no statistically significant interac-
There were two outliers in the data, as assessed tion between intervention and time for the indi-
by inspection of a boxplot for values > 1.5 box- vidual items of the POSAS Observer Scale. This
lengths from the edge of the box. One of the indicates that neither group performed better
outliers was found in the control group after over time. For the pliability score (P = 0.015)
one month compared to baseline; another out- and the overall opinion (P = 0.027) of the POSAS
lier was found in the intervention group at base- Observer Scale, a statistically significant differ-
line. Both outliers were kept, since comparison ence between the interventions was found at six
between the results with or without outliers months in favour of the ESWT group. The results
showed no significant differences. The data at the different timepoints of all POSAS Observer
were not normally distributed, as assessed by scores are presented in Table 3.
Shapiro–Wilk test of normality (P < 0.05). There were no statistically significant differ-
However, the histogram showed normally dis- ences between the interventions for the bright-
tributed data. This non-normality did not affect ness and the redness parameter of colorimetry
our analysis since comparison of with or without and for TEWL. The results at the different time-
transformed data showed no significant differ- points of objective assessment results are shown
ences. There was a statistically significant inter- in Table 4.
action between the intervention and time with
moderate effect size on elasticity, F(3,114) = Discussion
4.562, P = 0.011, partial η2 = 0.107. After adjust-
ment for baseline values, a statistically signifi- The present study is the first randomised con-
cant mean difference of 0.23 mm for elasticity trolled study on humans to investigate the effects
between the interventions was found after six of ESWT on the elasticity of burn scars with an
months in favour of the intervention group, objective assessment device. This study’s results
F(1,37) = 9.288, P = 0.004, partial η2 = 0.201. pointed out that the ESWT group performed sta-
Please note the large effect size here. The results tistically significantly better than a placebo group
are set out in Figure 3. to improve vertical elasticity of burn scars.
Table 2. POSAS Patient scores of ESWT versus placebo at baseline (T0), after one month (T1), three months (T2) and six months (T3).
ESWT Placebo
T0 T1 T2 T3* T0 T1 T2 T3*
Pain 2.90 (1.88–3.92) 2.15 (1.44–2.86) 2.00 (1.21–2.79) 1.35 (0.88–1.82) 2.65 (1.63–3.67) 2.20 (1.49–2.91) 2.35 (1.56–3.14) 1.55 (1.08–2.02)
0.56 0.64
Itch 3.65 (2.42–4.88) 3.00 (1.95–4.05) 2.75 (1.63–3.87) 1.95 (1.16–2.74) 3.45 (2.22–4.68) 3.00 (1.95–4.05) 3.30 (2.18–4.42) 2.65 (1.86–3.44)
0.82 0.34
Colour 6.65 (5.70–7.60) 5.95 (4.74–7.16) 4.65 (3.67–5.63) 4.05 (3.09–5.01) 7.40 (6.45–8.35) 6.20 (4.99–7.41) 5.55 (4.57–6.53) 4.80 (3.84–5.76)
1.67 1.06
Stiffness 6.35 (5.27–7.43) 4.80 (3.79–5.81) 4.30 (3.21–5.39) 3.55 (2.59–4.51) 6.70 (5.62–7.78) 5.20 (4.19–6.21) 4.80 (3.71–5.89) 4.20 (3.24–5.16)
1.27 1.14
Irregularity 4.20 (3.12–5.28) 4.15 (3.04–5.26) 3.70 (2.57–4.83) 3.45 (2.37–4.53) 5.15 (4.07–6.23) 4.60 (3.49–5.71) 4.75 (3.62–5.88) 3.75 (2.67–4.83)
0.39 0.53
Overall opinion 5.80 (4.55–7.05) 5.05 (4.02–6.08) 4.10 (3.08–5.12) 2.95 (2.17–3.73) 5.80 (4.55–7.05) 5.20 (4.17–6.23) 5.40 (4.38–6.42) 4.20 (3.42–4.98)
1.34 0.68
Values are given as mean (95% CI). Values in italics are Cohen’s d.
*Estimates of effect size based on differences between means after 6 months compared to baseline.
CI, confidence interval; ESWT, extracorporeal shock wave therapy; POSAS, Patient and Observer Scar Assessment Scale.
Scars, Burns & Healing
Moortgat et al.
Table 3. POSAS scores of ESWT versus placebo at baseline (T0), after 1 month (T1), 3 months (T2) and 6 months (T3).
ESWT Placebo
T0 T1 T2 T3* T0 T1 T2 T3*
Vascularity 4.95 (4.27–5.64) 4.35 (3.71–4.99) 3.90 (3.27–4.53) 3.00 (2.53–3.47) 5.00 (4.32–5.69) 3.90 (3.26–4.54) 3.80 (3.17–4.43) 3.20 (2.73–3.67)
1.58 1.38
Pigmentation 2.75 (1.91–3.59) 2.70 (2.03–3.37) 2.65 (1.97–3.33) 2.25 (1.74–2.76) 3.25 (2.41–4.09) 3.05 (2.38–3.72) 3.00 (2.32–3.68) 3.00 (2.49–3.51)
0.37 0.15
Thickness 3.10 (2.48–3.72) 2.85 (2.24–3.46) 2.60 (1.98–3.22) 2.35 (1.86–2.84) 3.05 (2.43–3.67) 2.60 (1.99–3.21) 2.55 (1.93–3.17) 2.65 (2.16–3.14)
0.61 0.34
Relief 3.45 (2.92–3.98) 3.10 (2.63–3.57) 3.00 (2.47–3.53) 2.50 (2.03–2.97) 3.10 (2.57–3.63) 2.85 (2.38–3.32) 3.00 (2.47–3.53) 2.75 (2.28–3.22)
Pliability 5.50 (4.78–6.22) 4.05 (3.37–4.74) 3.40 (2.83–3.97) 2.45 (2.03–2.87) 5.30 (4.58–6.02) 4.25 (3.57–4.93) 3.70 (3.13–4.27) 3.10 (2.68–3.52)
2.58 1.64
Surface area 5.00 (4.87–5.13) 4.70 (4.37–5.03) 4.35 (4.00–4.70) 4.30 (3.87–4.73) 5.00 (4.91–5.09) 4.75 (4.45–5.05) 4.65 (4.20–5.10) 4.15 (3.49–4.81)
1.54 1.52
Overall opinion 5.05 (4.64–5.46) 4.20 (3.75–4.66) 3.55 (3.12–3.98) 3.00 (2.66–3.34) 4.90 (4.49–5.30) 4.20 (3.75–4.66) 3.80 (3.37–4.23) 3.55 (3.21–3.89)
2.48 1.72
Values are given as mean (95% CI). Values in italics are Cohen’s d.
*Estimates of effect size based on differences between means after 6 months compared to baseline.
CI, confidence interval; ESWT, extracorporeal shock wave therapy; POSAS, Patient and Observer Scar Assessment Scale.
7
8 Scars, Burns & Healing
54.45 (51.8–57.1)
13.21 (11.9–14.5)
13.99 (10.3–17.7)
0.54 (0.42–0.66)
scores did not reveal any statistically significant
time versus intervention interactions between
the two groups, while the objective measurement
0.86
1.01
0.40
0.27
of elasticity with Cutometer® showed a statisti-
T3*
14.80 (13.7–15.9)
13.32 (10.0–16.6)
0.53 (0.40–0.66)
means that the subjective results did not back up
the objective outcomes. This could be explained
by the different assessment methods. The three
assessment methods assess different mechanical
properties.23 For the POSAS Patient Scale, the
T2
Table 4. Objective assessment results of ESWT versus placebo at baseline (T0), after one month (T1), three months (T2) and six months (T3).
15.25 (14.0–16.5)
15.00 (11.6–18.4)
16.37 (14.9–17.8)
17.57 (13.9–21.3)
0.48 (0.36-0,59)
13.4 (11.8–14.5)
0.77 (0.65–0.89)
10.55 (6.8–14.3)
1.30
0.89
1.10
T3*
14.46 (13.3–15.6)
0.68 (0.55–0.81)
Values are given as mean (95% CI). Values in italics are Cohen’s d.
15.33 (14.1–16.6)
13.87 (10.5–17.3)
0.56 (0.43–0.68)
17.14 (15.7–18.6)
17.12 (13.4–20.8)
0.46 (0.34–0.58)
the pulse frequency, and the number and interval does seem to give added value to the ‘standard of
of treatments are the most relevant parameters.29 care’ to improve the elasticity of burn scars.
Differences in the device settings can lead to vary-
ing outcomes, emphasising the dose dependency
of these mechanotransduction events.30 High- Conclusion
energy ESWT can suppress cell growth, while ESWT can give added value to the non-invasive
lower-energy shock waves might enhance cell pro- treatment of hypertrophic burn scars, more spe-
liferation.31 Since ESWT settings of 0.22 mJ/mm2 cifically to improve elasticity already in the first
and 1000 pulses seem to be ideal for fibroblast three months after wound closure.
viability and growth,32 and an EFD of 0.32 mJ/
mm2 reduces the expression of type-I collagen,24
Declaration of Conflicting Interests
we opted for an EFD of 0.25 mJ/mm2 and 30–50
shocks per cm2. This was also comparable with The author(s) declared no potential conflicts of interest
the previous studies performed on scars.13–15 with respect to the research, authorship, and/or publica-
tion of this article.
Two studies reported a significant decrease of
burn-associated pruritus.16,33 This finding is con-
sistent with the results from this study of which Funding
the POSAS Patient Scale revealed a significant The author(s) received no financial support for the
reduction for the itch parameter only for the research, authorship, and/or publication of this article.
ESWT group. However, this result did not lead to
a statistically significant difference between both ORCID iD
treatment arms, which can be explained by the
Peter Moortgat https://orcid.org/0000-0002-6840-762X
application of a ‘standard of care’ including
hydration and silicone for both groups. In the
studies by Joo et al.16 and Samhan et al.,33 75% of Bibliography
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