Status:
RECRUITING
Cost-Effectiveness of ESWT Plus Rehabilitation vs Rehabilitation Alone in Post-Burn Scars
Lead Sponsor:
Al Hayah University In Cairo
Conditions:
Hypertrophic Scar
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This randomized controlled trial (RCT) will evaluate the cost-effectiveness of combining extracorporeal shock wave therapy (ESWT) with standard rehabilitation versus standard rehabilitation alone for ...
Detailed Description
Post-burn hypertrophic scars can cause significant pain and pruritus, substantially affecting quality of life and functionality. Although ESWT has been recently associated with enhanced scar maturatio...
Eligibility Criteria
Inclusion
- Adults aged 18-65 years. Documented hypertrophic scars following a burn injury, with scars present and stable for at least 6 months.
- Moderate to severe scar severity as measured by a standardized clinical assessment.
- Experiencing significant pain and/or pruritus related to the scar, with a baseline VAS score of ≥4.
- Able to provide informed consent and comply with study procedures. Employed or engaged in daily activities such that indirect costs (absenteeism/reduced productivity) can be recorded.
Exclusion
- Pregnant or lactating women. Individuals with previous surgical scar revision or other invasive scar treatments within the last 6 months.
- Patients with comorbid conditions (e.g., severe cardiovascular disease, uncontrolled diabetes) that could interfere with rehabilitation or ESWT.
- Active skin infection in the area of the scar. Use of concurrent investigational therapies for scar management.
Key Trial Info
Start Date :
April 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT06913257
Start Date
April 22 2025
End Date
June 1 2027
Last Update
April 6 2025
Active Locations (1)
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1
Faculty of Physical Therapy, Al Hayah University
Cairo, Egypt, 12311