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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Pain Intensity (Visual Analog Scale [VAS])
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •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.
排除标准
- •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.
结局指标
主要结局
Pain Intensity (Visual Analog Scale [VAS])
时间窗: Assessed at baseline, 1 month, 3 months, and 6 months post-intervention.
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
时间窗: Evaluated at 6 months post-intervention.
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.
次要结局
- Pruritus Intensity (Itch Man Scale)(Measured at baseline, 1 month, 3 months, and 6 months post-intervention.)
- Indirect Costs (Absenteeism and Reduced Productivity)(Evaluated cumulatively over the 6-month follow-up period.)
- Scar Quality (Vancouver Scar Scale [VSS])(Assessed at baseline, 1 month, 3 months, and 6 months post-intervention.)
- Direct Medical Costs(Collated over the 6-month study period.)