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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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, f
• Поведенческое 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.

Первичные конечные точки

• Pain Intensity (Visual Analog Scale [VAS]) [Срок оценки: Assessed at baseline, 1 month, 3 months, and 6 months post-intervention.]
• Cost per Quality-Adjusted Life Year (QALY) Gained [Срок оценки: Evaluated at 6 months post-intervention.]

Вторичные конечные точки (4)

• Pruritus Intensity (Itch Man Scale) [Срок оценки: Measured at baseline, 1 month, 3 months, and 6 months post-intervention.]
• Scar Quality (Vancouver Scar Scale [VSS]) [Срок оценки: Assessed at baseline, 1 month, 3 months, and 6 months post-intervention.]
• Direct Medical Costs [Срок оценки: Collated over the 6-month study period.]
• Indirect Costs (Absenteeism and Reduced Productivity) [Срок оценки: Evaluated cumulatively over the 6-month follow-up period.]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Physical Therapy, Al Hayah University — Cairo

Идентификаторы

NCT: NCT06913257 · ESWT-BurnCE2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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