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NCT Number: NCT06913257

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

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.

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Key information

Conditions

Hypertrophic Scar Cicatrix Cicatrix, Hypertrophic Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Al Hayah University

Cairo, 12311, Egypt

Location status: Recruiting

Location contact

Mohamed ElMeligie, Ph.D

CONTACT

[email protected]

01159880001 ext. +20

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain Intensity (Visual Analog Scale [VAS])

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

    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.

  2. Cost per Quality-Adjusted Life Year (QALY) Gained

    Time frame: Evaluated at 6 months post-intervention.

    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.

Secondary outcomes

  1. Pruritus Intensity (Itch Man Scale)

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

    Pruritus will be quantified using the Itch Man Scale, a validated instrument designed to assess the severity and frequency of itching, which is a common symptom in post-burn scars.

  2. Scar Quality (Vancouver Scar Scale [VSS])

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

    The Vancouver Scar Scale (VSS) will be employed to evaluate scar characteristics such as vascularity, pliability, height, and pigmentation. This scale is widely used for the objective assessment of burn scars.

  3. Direct Medical Costs

    Time frame: Collated over the 6-month study period.

    Direct medical costs include expenditures for therapy sessions, ESWT equipment usage, hospital visits, and any additional medical services related to the intervention. Data will be extracted from hospital billing records.

  4. Indirect Costs (Absenteeism and Reduced Productivity)

    Time frame: Evaluated cumulatively over the 6-month follow-up period.

    Indirect costs will encompass lost productivity and absenteeism, as estimated through participant-reported work absenteeism and validated economic questionnaires. These costs represent the broader societal impact of treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Ibrahim Zoheiry, Ph.D

CONTACT

[email protected]

01277774949 ext. +20

Sponsors and collaborators

Lead sponsor

Al Hayah University In Cairo

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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