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OpenTrials
Completed

NCT Number: NCT03697447

Endermotherapy With Burn Hypertrophic Scars

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.

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Key information

Conditions

Burn Scar

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal Burn Unit

Montreal, Quebec, H2X 1C9, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endermotherapy

Procedure

Endermotherapy massage (mechanic massage) of burn scar

Primary outcomes

  1. Skin Thickness Changes

    Time frame: baseline, 12, 24 and 36 weeks

    Ultrasound skin measures, mm

Secondary outcomes

  1. Cutometer Skin Elasticity Changes

    Time frame: baseline, 12, 24 and 36 weeks

    skin elasticity measures (r0- cutometer), mm

  2. Mexameter Skin Erythema Changes

    Time frame: 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.

  3. Itch Visual Analog Subjective Changes

    Time frame: baseline, 12, 24 and 36 weeks

    Itch, Visual analog scale (score 0-none to 10-worse)

  4. Pain Visual Analog Subjective Changes: VAS

    Time frame: baseline, 12, 24 and 36 weeks

    Pain, Visual analog scale (score 0-none to 10-worse)

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 5, 2018
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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