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

Al Hayah University In Cairo

Status: Enrolling

Conditions: Hypertrophic Scar

Treatments: Behavioral: Standard Rehabilitation Therapy Alone; Device: ESWT Combined with Standard Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06913257

ESWT-BurnCE2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

ESWT Plus Standard Rehabilitation

Experimental group

Description:

Participants in this arm will undergo extracorporeal shock wave therapy (ESWT) in addition to receiving standard rehabilitation therapy. ESWT will be administered using a standardized protocol, with treatment sessions conducted weekly for a predetermined duration, integrated with a rehabilitation program focused on scar management, functional restoration, and symptom relief.

Treatment:

Device: ESWT Combined with Standard Rehabilitation

Standard Rehabilitation Alone

Active Comparator group

Description:

Participants assigned to this arm will receive the standard rehabilitation therapy protocol designed for post-burn scar management. This regimen includes physical, occupational, and scar-specific therapy sessions delivered in a standardized fashion without the addition of ESWT.

Treatment:

Behavioral: Standard Rehabilitation Therapy Alone