Pratesi E1, Cervo M2, Ferrarello F3, Cerboneschi M2
1Azienda USL Toscana Centro, Functional Rehabilitation, Castelfiorentino (Florence), Italy, 2Meyer Children Hospital, Rehabilitation Service, Florence, Italy, 3Azienda USL Toscana Centro, Functional Rehabilitation, Prato, Italy
Background: Treatment of cutaneous scars is a relevant component in the management of wound healing. The Endermologie® is a noninvasive system which delivers a mechanical massage; cutaneous and subcutaneous tissues mobilization stimulate microcirculation, oxygenation, and the production of elastin and collagen. Previous studies showed that the equipment improves tissue hardness and elasticity; however, findings were not related to populations affected by scars. To explore the effect of Endermologie® as a treatment for cutaneous scars in a pediatric population, we designed a retrospective record review and prospective observational study.
Purpose: Purpose of the present study was a preliminary evaluation of participant responses to the intervention.
Methods: As part of the feasibility assessment of the main study protocol, we conducted an exploratory retrospective charts review. Records of a convenience sample of pediatric individuals ( 18 years) with cutaneous scars attending the outpatient clinic of Meyer Children's Hospital of Florence, Italy, were analyzed. Subjects had to have a well-established wound closure and subsequent functional and/or aesthetic harm. Participants underwent 10 sessions (twice a week, 15 minutes) of Endermologie® treatment applied by a physiotherapist. Demographic and clinical characteristics (age, years from wound, scar characteristics, previous/ongoing mechanical scar treatments), equipment setting, adherence rate, and adverse events were recorded. Outcome measures used for the assessment of scar variation over time were the Vancouver Scar Scale (VSS) and the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale. Baseline (T0), end-of-treatment (T1), and two-month follow-up (T2) data were collected. Descriptive statistics were performed. Scar variation over time was examined using the Friedman's test. Post-hoc analysis was performed with the Dunn's test and Hodges-Lehmann estimator. Analysis was intention to treat; missing data were dealt with by using the last-observation-carried-forward method. The significance level was set at p .05.
Results: Thirteen charts were reviewed. Age ranged from 4 to 16 years (median 7), years from wound from 1 to 10 (median 4). Adherence rate was 93% (95%CI=87/96); one patient did not attend the follow up at T2. Lesions were proportionately distributed between burn and surgical scars, and between trunk, upper-, and lower-limb areas. Scars were mainly retracting (69%, 95%CI=42/87) and adhesive (77%, 95%CI=50/92). Frequent previous/ongoing treatments were massage (85%, 95%CI=58/96) and silicone-based ones (69%, 95%CI=42/87). Baseline median (min,max) VSS, OSAS, and PSAS values were 5 (4,9), 30 (16,48), and 38 (19,48), respectively. No adverse events were detected. Friedman's tests showed a significant improvement in outcome measures (p=.019 to .001). Post-hoc tests showed a significant decrease in VSS score between T0 and T2 (p=.024, -1.5, 95%CI=-2.5/0.0); however, after adjusting for multiple testing differences were no more significant (adj.p=.072). OSAS and PSAS scores improved significantly between T0 and T1 (OSAS adj.p=.032, -5.0, 95%CI=-9.0/-3.0; PSAS adj.p=.024, -8.5, 95%CI=-14.0/-3.5) and even more between T0 and T2 (OSAS adj.p .001, -7.5, 95%CI=-15.5/-4.5; PSAS adj.p .001, -14.5, 95%CI=-18.5/-11.5).
Conclusion(s): The clinical data we observed are encouraging. Findings suggests that the intervention is likely to be successful.
Implications: If the main study confirms preliminary findings, this therapeutic approach should be considered for further testing in subsequent trials in this patient population.
Keywords: Mechanical massage, pediatric, cutaneous scars
Funding acknowledgements: The study was unfunded.
Purpose: Purpose of the present study was a preliminary evaluation of participant responses to the intervention.
Methods: As part of the feasibility assessment of the main study protocol, we conducted an exploratory retrospective charts review. Records of a convenience sample of pediatric individuals ( 18 years) with cutaneous scars attending the outpatient clinic of Meyer Children's Hospital of Florence, Italy, were analyzed. Subjects had to have a well-established wound closure and subsequent functional and/or aesthetic harm. Participants underwent 10 sessions (twice a week, 15 minutes) of Endermologie® treatment applied by a physiotherapist. Demographic and clinical characteristics (age, years from wound, scar characteristics, previous/ongoing mechanical scar treatments), equipment setting, adherence rate, and adverse events were recorded. Outcome measures used for the assessment of scar variation over time were the Vancouver Scar Scale (VSS) and the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale. Baseline (T0), end-of-treatment (T1), and two-month follow-up (T2) data were collected. Descriptive statistics were performed. Scar variation over time was examined using the Friedman's test. Post-hoc analysis was performed with the Dunn's test and Hodges-Lehmann estimator. Analysis was intention to treat; missing data were dealt with by using the last-observation-carried-forward method. The significance level was set at p .05.
Results: Thirteen charts were reviewed. Age ranged from 4 to 16 years (median 7), years from wound from 1 to 10 (median 4). Adherence rate was 93% (95%CI=87/96); one patient did not attend the follow up at T2. Lesions were proportionately distributed between burn and surgical scars, and between trunk, upper-, and lower-limb areas. Scars were mainly retracting (69%, 95%CI=42/87) and adhesive (77%, 95%CI=50/92). Frequent previous/ongoing treatments were massage (85%, 95%CI=58/96) and silicone-based ones (69%, 95%CI=42/87). Baseline median (min,max) VSS, OSAS, and PSAS values were 5 (4,9), 30 (16,48), and 38 (19,48), respectively. No adverse events were detected. Friedman's tests showed a significant improvement in outcome measures (p=.019 to .001). Post-hoc tests showed a significant decrease in VSS score between T0 and T2 (p=.024, -1.5, 95%CI=-2.5/0.0); however, after adjusting for multiple testing differences were no more significant (adj.p=.072). OSAS and PSAS scores improved significantly between T0 and T1 (OSAS adj.p=.032, -5.0, 95%CI=-9.0/-3.0; PSAS adj.p=.024, -8.5, 95%CI=-14.0/-3.5) and even more between T0 and T2 (OSAS adj.p .001, -7.5, 95%CI=-15.5/-4.5; PSAS adj.p .001, -14.5, 95%CI=-18.5/-11.5).
Conclusion(s): The clinical data we observed are encouraging. Findings suggests that the intervention is likely to be successful.
Implications: If the main study confirms preliminary findings, this therapeutic approach should be considered for further testing in subsequent trials in this patient population.
Keywords: Mechanical massage, pediatric, cutaneous scars
Funding acknowledgements: The study was unfunded.
Topic: Paediatrics; Musculoskeletal; Outcome measurement
Ethics approval required: Yes
Institution: Tuscany Region
Ethics committee: Regional Pediatric Ethics Committee for Experimentation
Ethics number: 110/2018
All authors, affiliations and abstracts have been published as submitted.
