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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Faculty of Physical Therapy, Al Hayah University

Cairo, Egypt, 12311