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

Last updated: March 30, 2025
Sponsor: Al Hayah University In Cairo
Overall Status: Active - Recruiting

Phase

N/A

Condition

Scar Tissue

Treatment

Standard Rehabilitation Therapy Alone

ESWT Combined with Standard Rehabilitation

Clinical Study ID

NCT06913257
ESWT-BurnCE2025
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 104
Treatment Group(s): 2
Primary Treatment: Standard Rehabilitation Therapy Alone
Phase:
Study Start date:
April 22, 2025
Estimated Completion Date:
June 01, 2027

Study 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.

Connect with a study center

  • Faculty of Physical Therapy, Al Hayah University

    Cairo, 12311
    Egypt

    Active - Recruiting

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