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 Criteria:
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 Criteria:
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