Endermotherapy With Burn Hypertrophic Scars

Study Overview
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Brief Summary
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Mechanical massage or endermotherapyTM is applied to scar tissue with the intended therapeutic value being the promotion of structural or physiological changes. These proposed changes are meant to induce more pliability, so that skin possesses the strength and elasticity required for normal mobility. The advantage of mechanical massage compared to manual massage is that it provides a standard dosage using rollers and suction valves to mobilize the tissue. However, research documenting and supporting this effect is lacking. The objective of this proposal is to document the effect of 12 weeks of endermotherapy treatment on hypertrophic scar characteristics, including erythema, pigmentation, pliability, and thickness in adult burn survivors and their subjective evaluation of itch, pain and overall scar outcome through a prospective, randomized, controlled, within-patient, single-blinded study.

Detailed Description
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Patients will receive 12 weeks of endermotherapy , 3 times a week.

Official Title
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Randomized, Controlled, Within-patient, Singleblind Study to Evaluate the Efficacy of 12-weeks of Endermotherapy With Adult Burn Survivors

Conditions
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Burn Scar

Intervention / Treatment
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* Procedure: Endermotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: females and males, of any race, 14 years or older, a thermal injury, at least 3 months post-burn so that the scars will be durable enough to tolerate the proposed forces, at least 2 scar sites >2.034 mm thick and within 0.5 mm of each other, and signed the informed patient consent form Exclusion Criteria: subjects who have keloids, with a diagnosis of psychiatric illness clearly documented in their medical file, mechanism of injury is an electrical, chemical, or cold injury, a dermatological conditions in the region of the evaluation site, that may interfere with the study results, a suspected or known allergy to ultrasound gel, unable to understand French or English, or subjects who refuse to give informed consent.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endermotherapy treated scar<br>Endermotherapy massage treatment | Procedure: Endermotherapy<br>* Endermotherapy massage (mechanic massage) of burn scar<br>|
| No Intervention: Control scar<br>No intervention, standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Thickness Changes | Ultrasound skin measures, mm | baseline, 12, 24 and 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cutometer Skin Elasticity Changes | skin elasticity measures (r0- cutometer), mm | baseline, 12, 24 and 36 weeks | 
| Mexameter Skin Erythema Changes | Erythema index measure by Mexameter, scale values of 0 to 999. The erythema values are individual for each person and depend strongly on the ethnic group. The measurements are generally used to determine changes before and after a treatment. | baseline, 12, 24 and 36 weeks | 
| Itch Visual Analog Subjective Changes | Itch, Visual analog scale (score 0-none to 10-worse) | baseline, 12, 24 and 36 weeks | 
| Pain Visual Analog Subjective Changes: VAS | Pain, Visual analog scale (score 0-none to 10-worse) | baseline, 12, 24 and 36 weeks |