Pulsed High Intensity Laser Versus Extracorporeal Shockwave Therapy on Hypertrophic Scar Post Burn
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2025
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2025
CompletedStudy Start
First participant enrolled
January 26, 2025
CompletedFirst Posted
Study publicly available on registry
January 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2025
CompletedJanuary 31, 2025
December 1, 2024
15 days
January 26, 2025
January 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modified Vancouver burn Scar assessment scale
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 Outcomes (1)
Aschiotz tonometer device
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)
Study Arms (2)
study group receives pulsed high intensity laser and coservative treatment
ACTIVE COMPARATORstudy group receives extracorporeal shockwave therapy and coservative treatment
ACTIVE COMPARATORInterventions
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 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
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (2)
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.
PMID: 35115845BACKGROUNDLee 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.
PMID: 32917473BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Haidy Nady Ashem, professor
faculty of physical therapy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- physiotherapist
Study Record Dates
First Submitted
January 26, 2025
First Posted
January 31, 2025
Study Start
January 26, 2025
Primary Completion
February 10, 2025
Study Completion
March 25, 2025
Last Updated
January 31, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share