Clinical trial NCT06913257: Cost-Effectiveness of ESWT Plus Rehabilitation vs Rehabilitation Alone in Post-Burn Scars
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertrophic Scar
Lead sponsor: Al Hayah University In Cairo
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants with post-burn hypertrophic scars will be randomized into two parallel arms. Stratified randomization based on scar severity ensures balanced allocation across groups. Each participant will receive a predetermined intervention and be followed for 6 months to assess changes in both clinical parameters and economic outcomes.
Primary purpose: TREATMENT

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.

Detailed description: 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.

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.

Primary outcomes:
measure: Pain Intensity (Visual Analog Scale [VAS])
timeFrame: Assessed at baseline, 1 month, 3 months, and 6 months post-intervention.
measure: Cost per Quality-Adjusted Life Year (QALY) Gained
timeFrame: Evaluated at 6 months post-intervention.
Secondary outcomes:
measure: Pruritus Intensity (Itch Man Scale)
timeFrame: Measured at baseline, 1 month, 3 months, and 6 months post-intervention.
measure: Scar Quality (Vancouver Scar Scale [VSS])
timeFrame: Assessed at baseline, 1 month, 3 months, and 6 months post-intervention.
measure: Direct Medical Costs
timeFrame: Collated over the 6-month study period.
measure: Indirect Costs (Absenteeism and Reduced Productivity)
timeFrame: Evaluated cumulatively over the 6-month follow-up period.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy, Al Hayah University
Study officials:
References: