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