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.
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Parallel
ESWT Combined with Standard Rehabilitation
DeviceParticipants 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.
Standard Rehabilitation Therapy Alone
BehavioralParticipants 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.
Pain Intensity (Visual Analog Scale [VAS])
This measure evaluates the intensity of pain experienced by participants, using a 10-centimeter Visual Analog Scale where 0 indicates "no pain" and 10 indicates "worst pain imaginable." The VAS is a validated, standardized tool allowing for quantitative measurement of patient-reported pain intensity changes over time.
Cost per Quality-Adjusted Life Year (QALY) Gained
This economic outcome will be determined by calculating the incremental cost per QALY gained using validated health-related quality-of-life instruments (eg, EQ-5D) alongside hospital billing data. It compares the cumulative costs (both direct and indirect) and QALYs between the ESWT plus rehabilitation arm versus the rehabilitation alone arm over a 6-month period.
Pruritus Intensity (Itch Man Scale)
Pruritus will be quantified using the Itch Man Scale, a validated instrument designed to assess the severity and frequency of itching, which is a common symptom in post-burn scars.
Scar Quality (Vancouver Scar Scale [VSS])
The Vancouver Scar Scale (VSS) will be employed to evaluate scar characteristics such as vascularity, pliability, height, and pigmentation. This scale is widely used for the objective assessment of burn scars.
Direct Medical Costs
Direct medical costs include expenditures for therapy sessions, ESWT equipment usage, hospital visits, and any additional medical services related to the intervention. Data will be extracted from hospital billing records.
Indirect Costs (Absenteeism and Reduced Productivity)
Indirect costs will encompass lost productivity and absenteeism, as estimated through participant-reported work absenteeism and validated economic questionnaires. These costs represent the broader societal impact of treatment.
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