Burn Scar
Conditions
Brief summary
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
Patients will receive 12 weeks of endermotherapy , 3 times a week.
Interventions
PROCEDUREEndermotherapy
Endermotherapy massage (mechanic massage) of burn scar
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Thickness Changes | baseline, 12, 24 and 36 weeks | Ultrasound skin measures, mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cutometer Skin Elasticity Changes | baseline, 12, 24 and 36 weeks | skin elasticity measures (r0- cutometer), mm |
| Mexameter Skin Erythema Changes | baseline, 12, 24 and 36 weeks | 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. |
| Itch Visual Analog Subjective Changes | baseline, 12, 24 and 36 weeks | Itch, Visual analog scale (score 0-none to 10-worse) |
| Pain Visual Analog Subjective Changes: VAS | baseline, 12, 24 and 36 weeks | Pain, Visual analog scale (score 0-none to 10-worse) |
Countries
Canada
Outcome results
None listed