Pulsed High Intensity Laser Versus Extracorporeal Shockwave Therapy on Hypertrophic Scar Post Burn

January 26, 2025 updated by: Amira Fayed Ali Ibrahim, Cairo University

The goal of this clinical trial stydy : is to compare between the effect of pulsed high intensity laser and extracorporeal shockwave therapy on hypertrophic scar on post burned patients.

The main questions is it aims to answer is :

  • Which is more effective on hypertrophic scar post burn Extracorporeal shockwave therapy or pulsed high intensity laser therapy?
  • Participants will receive the treatment for 6 weeks.
  • Assesment will be don before and after treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Subjects :

    Sixty patients have hypertrophic scar post burn. They will be selected from El Gamaa hospital and randomly distributed into two equal groups. Their ages will be ranged from 20 to 45 years.

  2. Design of the study :

In this study, the patients will be randomly divided into two equal groups in number (30 patients each).

  1. Group A (pulsed high intensity laser group):

    In this group of the study, thirty patients whom have hypertrophic scar post burn injury will receive pulsed high intensity laser in addition to traditional physiotherapy (deep friction massage and stretching exercises) for six weeks. The application will be three times per week.

  2. Group B (Extracorporeal shockwave group):

In this group of the study, thirty patients whom have hypertrophic scar post burn injury will receive Extracorporeal shockwave therapy in addition to traditional physiotherapy (deep friction massage and stretching exercises) for six weeks. The application will be two times per week.

Equipments :

.Measurement equipments :

  1. Modified Vancouver burn Scar assessment scale :

    Modified Vancouver scar scale (VSS), an observer-dependent scale of the macroscopic appearance of scarring, was used to measure changes in the scar over the period of treatment.

    The Modified Vancouver Scar Scale score is probably the most widely known scar scale that consists of three components (vascularization, pliability and scar height); the total score ranges from 0 to 11, with 0 representing normal skin.To assess 3 variables of scar characteristics: Vascularity, pliability and height.

    Scoring; vascularity ranged from 0 to 3 (1 Pink, 2 Red, 3 Purple), pliability ranged from 0 to 5 (1 Supple, 2 Yielding, 3 Firm, 4 Ropes, 5 Contracture) and height ranged from 0 to 3 (1 Less than 2 mm, 2 From 2 to 5 mm, 3 More than 5 mm). The larger the total score, the worse the HTS. The investigators choose an algebraic value for any of these characteristics based on a comparison with normal skin (zero score)

  2. A Schiotz tonometer scale :

This scale will be used as an objective scale to asses the hypertrophic scar pliability and elasticity.

The tissue tonometer provides a repeatable and objective index of burn scar pliability. it is a simple, clinically useful technique for monitoring an individual's scar.

To assess scar pliability and elasticity improvement by an objective manner It is held vertically at a measured point of the scar, so the plunger moved downwards by gravity and indent the scar tissue. The instrument gives a reading on a horizontal scale numbered arbitrarily from 0 to 20, but the device does not measure scar pressure directly, a conversion table, supplied with the Schiotz tonometer pressure directly, a conversion table, supplied with the Schiotz tonometer, is used to translate the instrument readings into measurements by mmHg .

Treatment procedure :

  1. Pulsed High Intensity Laser application procedure:

    • Should wear laser-protective glasses or goggles.
    • Inappropriate use of the goggles is more dangerous than their non-use, as they may provide a false sense of security.
    • Laser equipment should be placed in a controlled area with minimal access to avoid inadvertent exposure.
    • Avoid laser reflection from mirrored surfaces.
    • Avoid exposure of eyes, unclosed fontanels of children.
    • Applied at at fluence of 40 J/cm2 , pulse duration of 0.3 m/s , spot size of 5 mm in a focused mode for 3 passes.

  2. Extracorporeal shockwave application procedure:

    • Patients will receive sessions of ESWT twice a week for 6 weeks.
    • ESWT will be administered on an outpatient basis; the selected treatment area is usually the most uncomfortable for the patient. Patient placed into comfortable position that allowed the vision of the treated area.
    • Each treatment region covered with 2500 to 3000 impulses with average session time 10-15 min.

conservative treatment for both groups: (Stretching exercises and Deep friction massage ) 2 sessions per week for 6 weeks

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • The patients age will range from 20 to 45 years.
  • All patients will be free from any other pathological conditions or histories except hypertrophic scar.
  • patients will be selected from both gender.
  • All patients will have hypertrophic scars post burn injuries.

Exclusion Criteria:

  • The patients who have open wound at or near treatment site.
  • The patients who have cardiac pacemakers or other implanted electronic devices.
  • The patients who have any significant health problem such as diabetes, circulatory
  • disorders or history of skin malignancy in the treated area.
  • uncooperative patients.
  • The patients who have a deep venous thrombosis (DVT).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: study group receives pulsed high intensity laser and coservative treatment
Device: pulsed high intensity laser therapy
The high-intensity laser therapy (HILT), which involves laser radiation with high-intensity, is a kind of novel and powerful . The HILT possesses its own photomechanical, photothermal, and the photo-chemical properties.
Active Comparator: study group receives extracorporeal shockwave therapy and coservative treatment
Device: Extracorporeal shockwave therapy
Extracorporeal shockwave therapy is an acoustic wave that mechanically disrupts tissue by cavitation.Shock waves develop microscopic injuries in scar tissue and break down collagen fibers which lead to scar remodelin .The patient is positioned in a comfortable position. The scar site is prepared with contact gel to conduct the shock waves, 30-50 shocks/cm2 , with an energy flux density of 0.25mJ/mm2 and a frequency of 6Hz. Each treatment region is covered with 2500 to 3000 impulses with an average session time of 10-15min .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Vancouver burn Scar assessment scale
Time Frame: change of the total score from the begginning of the treatment to the end of the treatment (after 6 weeks from the begginning of the treatment)
Modified Vancouver scar scale , an observer-dependent scale of the macroscopic appearance of scarring, is used to measure changes in the scar over the period of treatment,The Modified Vancouver Scar Scale score is probably the most widely known scar scale that consists of three components (vascularization, pliability and scar height); the total score ranges from 0 to 11, with 0 representing normal skin ,Scoring; vascularity ranged from 0 to 3 (1 Pink, 2 Red, 3 Purple), pliability ranged from 0 to 5 (1 Supple, 2 Yielding, 3 Firm, 4 Ropes, 5 Contracture) and height ranged from 0 to 3 (1 Less than 2 mm, 2 From 2 to 5 mm, 3 More than 5 mm). The larger the total score, the worse the HTS. The investigators choose an algebraic value for any of these characteristics based on a comparison with normal skin (zero score).
change of the total score from the begginning of the treatment to the end of the treatment (after 6 weeks from the begginning of the treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aschiotz tonometer device
Time Frame: change of the hypertrohic scar pressure score from the begginning of the treatment to the end of the treatment (after 6 weeks from the begginning of the treatment)

Aschiotz tonometer device, will be used as an objective scale to asses the hypertrophic scar pliability and elasticity.

The tissue tonometer provides a repeatable and objective index of burn scar pliability. it is a simple, clinically useful technique for monitoring an individual's scar It is held vertically at a measured point of the scar, so the plunger moved downwards by gravity and indent the scar tissue. The instrument gives a reading on a horizontal scale numbered arbitrarily from 0 to 20, but the device does not measure scar pressure directly, a conversion table, supplied with the Schiotz tonometer, is used to translate the instrument readings into measurements by mmHg.
change of the hypertrohic scar pressure score from the begginning of the treatment to the end of the treatment (after 6 weeks from the begginning of the treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Haidy Nady Ashem, professor, Faculty of Physical Therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 26, 2025

Primary Completion (Estimated)

February 10, 2025

Study Completion (Estimated)

March 25, 2025

Study Registration Dates

First Submitted

January 26, 2025

First Submitted That Met QC Criteria

January 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 26, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/004524

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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