Al Hayah University in Cairo
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.
Hypertrophic Scar
ESWT Combined with Standard Rehabilitation
Standard Rehabilitation Therapy Alone
NA
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 104 participants |
| Masking : | SINGLE |
| Masking Description : | While participants, care providers, and investigators will be aware of the intervention provided, outcome assessors and the economic evaluation team will remain blinded to group allocation to reduce bias in outcome measurement and cost data analysis. |
| Primary Purpose : | TREATMENT |
| 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 |
| Actual Study Start Date : | 2025-04-22 |
| Estimated Primary Completion Date : | 2027-06-01 |
| Estimated Study Completion Date : | 2027-06-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 65 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Faculty of Physical Therapy, Al Hayah University
Cairo, Egypt, 12311