An interventional study of Endermotherapy in Burn Scar, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 1 site in Canada. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Treatment
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.
Patients will receive 12 weeks of endermotherapy , 3 times a week.
Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.
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Exclusion Criteria:
Endermotherapy massage treatment
Procedure: Endermotherapy
No intervention, standard of care
Endermotherapy massage (mechanic massage) of burn scar
Skin Thickness Changes
Ultrasound skin measures, mm
Time frame: baseline, 12, 24 and 36 weeks
Cutometer Skin Elasticity Changes
skin elasticity measures (r0- cutometer), mm
Time frame: 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.
Time frame: baseline, 12, 24 and 36 weeks
Itch Visual Analog Subjective Changes
Itch, Visual analog scale (score 0-none to 10-worse)
Time frame: baseline, 12, 24 and 36 weeks
Pain Visual Analog Subjective Changes: VAS
Pain, Visual analog scale (score 0-none to 10-worse)
Time frame: baseline, 12, 24 and 36 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2017 to primary completion in Feb 2020, 35 months.
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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