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

NCT06913257 | Recruiting

• 1 other identifier: ESWT-BurnCE2025
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Scar

Outcome Measures

Primary Outcomes (2)

• Pain Intensity (Visual Analog Scale [VAS])

  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.

  Assessed at baseline, 1 month, 3 months, and 6 months post-intervention.

• Cost per Quality-Adjusted Life Year (QALY) Gained

  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.

  Evaluated at 6 months post-intervention.

Secondary Outcomes (4)

• Pruritus Intensity (Itch Man Scale)

  Measured at baseline, 1 month, 3 months, and 6 months post-intervention.

• 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.

• Indirect Costs (Absenteeism and Reduced Productivity)

  Evaluated cumulatively over the 6-month follow-up period.

Study Arms (2)

ESWT Plus Standard Rehabilitation

EXPERIMENTAL

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.

Device: ESWT Combined with Standard Rehabilitation

Standard Rehabilitation Alone

ACTIVE COMPARATOR

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.

Behavioral: Standard Rehabilitation Therapy Alone

Interventions

ESWT Combined with Standard Rehabilitation DEVICE

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, frequency) will be reported based on established guidelines.

ESWT Plus Standard Rehabilitation

Standard Rehabilitation Therapy Alone BEHAVIORAL

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.

Standard Rehabilitation Alone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al Hayah University In Cairo: lead

Study Sites (1)

Faculty of Physical Therapy, Al Hayah University

Cairo, 12311, Egypt

RECRUITING

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ibrahim Zoheiry, Ph.D

CONTACT

01277774949; ibrahim.alzoheiry@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 6, 2025
• Study Start: April 22, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)