Endermotherapy With Burn Hypertrophic Scars

Burn Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03697447
• Other study ID #: 15.374
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2017
• Est. completion date: March 13, 2026

Study information

• Verified date: November 2022
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Ana De Oliveira
• Phone: 514-288-8201
• Email: ana.de-oliveira.chum[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: March 13, 2026
• Est. primary completion date: February 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Burn Scar
• Burns

Intervention

Procedure:
• Endermotherapy
Endermotherapy massage (mechanic massage) of burn scar

Locations

Country	Name	City	State
Canada	Montreal Burn Unit	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin Thickness Changes	Ultrasound skin measures, mm	baseline, 12, 24 and 36 weeks
Secondary	Cutometer Skin Elasticity Changes	skin elasticity measures (r0- cutometer), mm	baseline, 12, 24 and 36 weeks
Secondary	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
Secondary	Itch Visual Analog Subjective Changes	Itch, Visual analog scale (score 0-none to 10-worse)	baseline, 12, 24 and 36 weeks
Secondary	Pain Visual Analog Subjective Changes: VAS	Pain, Visual analog scale (score 0-none to 10-worse)	baseline, 12, 24 and 36 weeks