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RECRUITING
NCT06913257
NA

Cost-Effectiveness of ESWT Plus Rehabilitation vs Rehabilitation Alone in Post-Burn Scars

Sponsor: Al Hayah University In Cairo

View on ClinicalTrials.gov

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 the management of hypertrophic post-burn scars in adults. The study will assess clinical outcomes-such as pain intensity, pruritus, and scar quality-alongside economic outcomes including cost per quality-adjusted life year (QALY) gained, direct medical costs, and indirect costs (e.g., absenteeism and reduced productivity). Results will inform health policy and resource allocation decisions for advanced burn rehabilitation interventions.

Official title: Cost-Effectiveness Analysis of Extracorporeal Shock Wave Therapy (ESWT) Combined With Standard Rehabilitation Versus Standard Rehabilitation Alone in Managing Post-Burn Scars: A Randomized Controlled Trial With Integrated Economic Evaluation

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2025-04-22

Completion Date

2027-06-01

Last Updated

2025-04-06

Healthy Volunteers

No

Interventions

DEVICE

ESWT Combined with Standard Rehabilitation

Participants in the experimental arm will receive a combination intervention comprising ESWT delivered by certified technicians using a validated device for post-burn scars, along with standard rehabilitation therapy. ESWT sessions will be standardized (e.g., 3,000 pulses per session, weekly for 8 weeks) and will be integrated with a comprehensive rehabilitation program encompassing physical therapy, scar management exercises, and patient education. The specific parameters (e.g., energy level, frequency) will be reported based on established guidelines.

BEHAVIORAL

Standard Rehabilitation Therapy Alone

Participants in the control arm will receive the institution's standard rehabilitation therapy for managing post-burn scars, including physical therapy, occupational therapy, and scar-massage techniques. Treatment frequency and duration will mirror the experimental arm's rehabilitation component to ensure consistency. No ESWT will be provided.

Locations (1)

Faculty of Physical Therapy, Al Hayah University

Cairo, Egypt