NCT06913257

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Al Hayah University In Cairo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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 maturation and symptom reduction (Yang et al., 2022), its implementation into standard care is limited by a lack of economic evaluation. This trial is a prospective, randomized controlled study with an integrated cost-effectiveness analysis. Adult patients (aged 18-65) with hypertrophic scars at least 6 months post-burn injury will be recruited and stratified by scar severity. Participants will be randomized into one of two arms: Arm 1 (Experimental): ESWT combined with standardized rehabilitation therapy. Arm 2 (Active Comparator): Standard rehabilitation therapy alone. Primary clinical outcomes will include changes in pain intensity (measured on a Visual Analog Scale \[VAS\]), pruritus intensity (using the Itch Man Scale), and scar quality (assessed through the Vancouver Scar Scale \[VSS\]). Economic outcomes will be determined by calculating the cost per QALY gained along with an assessment of both direct (therapy sessions, equipment use, hospital visits) and indirect costs (absenteeism, lost productivity). Data will be collected at baseline and at follow-up visits at 1, 3, and 6 months post-intervention.

Conditions

• Hypertrophic Scar

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-22
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-04-06
• Last updated: 2025-04-06

Locations

1 site across 1 country: Egypt