Endermotherapy With Burn Hypertrophic Scars

Not Applicable

Completed

• Conditions: Burn Scar
• Interventions: Procedure: Endermotherapy

• Registration Number: NCT03697447
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Study Timeline

• Study Start: 2017-02-13
• Study First Submitted: 2018-03-22
• Study First Submitted QC: 2018-10-04
• Study First Posted: 2018-10-05
• Primary Completion: 2020-02-05
• Study Completion: 2020-02-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endermotherapy treated scar	Endermotherapy	Endermotherapy massage treatment

Primary Outcome Measures

Name	Time	Method
Skin Thickness Changes	baseline, 12, 24 and 36 weeks	Ultrasound skin measures, mm

Secondary Outcome Measures

Name	Time	Method
Itch Visual Analog Subjective Changes	baseline, 12, 24 and 36 weeks	Itch, Visual analog scale (score 0-none to 10-worse)
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.
Pain Visual Analog Subjective Changes: VAS	baseline, 12, 24 and 36 weeks	Pain, Visual analog scale (score 0-none to 10-worse)

Trial Locations

Locations (1)

Montreal Burn Unit; 🇨🇦 Montreal, Quebec, Canada