Pulsed High Intensity Laser Versus Extracorporeal Shockwave Therapy on Hypertrophic Scar Post Burn
NCT ID: NCT06803472
Last Updated: 2025-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-01-26
2025-03-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
Groyp B (30 patients recaive extracorporeal shockwave therapy plus traditional PT treatment for post burn hypertrophic scar.
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
study group receives pulsed high intensity laser and coservative treatment
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.
study group receives extracorporeal shockwave therapy and coservative treatment
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 .
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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 .
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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).
20 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Amira Fayed Ali Ibrahim
physiotherapist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Haidy Nady Ashem, professor
Role: STUDY_DIRECTOR
faculty of physical therapy
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Ruchiatan K, Suhada KU, Hindritiani R, Puspitosari D, Septrina R. Combination of 1064 nm Long-Pulsed and Q-Switched Nd:YAG Laser for Facial Hypertrophic Scar and Hyperpigmentation Following Burn Injury. Int Med Case Rep J. 2022 Jan 25;15:23-27. doi: 10.2147/IMCRJ.S348091. eCollection 2022.
Lee SY, Joo SY, Cho YS, Hur GY, Seo CH. Effect of extracorporeal shock wave therapy for burn scar regeneration: A prospective, randomized, double-blinded study. Burns. 2021 Jun;47(4):821-827. doi: 10.1016/j.burns.2020.08.009. Epub 2020 Aug 29.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P.T.REC/012/004524
Identifier Type: -
Identifier Source: org_study_id