Endermotherapy With Burn Hypertrophic Scars

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

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.

Study Overview

• Status: Completed
• Conditions: Burn Scar
• Intervention / Treatment: Procedure: Endermotherapy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X 1C9
      • Montreal Burn Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control scar; No intervention, standard of care
Experimental: Endermotherapy treated scar; Endermotherapy massage treatment	Procedure: Endermotherapy; Endermotherapy massage (mechanic massage) of burn scar

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Bernadette Nedelec, PhD, CRCHUM

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2017
• Primary Completion (Actual): February 5, 2020
• Study Completion (Actual): February 5, 2020

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: October 4, 2018
• First Posted (Actual): October 5, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 15.374

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No