Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06913257

Cost-Effectiveness Analysis of Extracorporeal Shock Wave Therapy Combined With Standard Rehabilitation Versus Standard Rehabilitation Alone in Managing Post-Burn Scars

Led by Al Hayah University In Cairo · Updated on 2025-04-06

104

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the cost-effectiveness of extracorporeal shock wave therapy (ESWT) combined with standard rehabilitation compared to standard rehabilitation alone for adults with hypertrophic post-burn scars. The study focuses on clinical outcomes like pain intensity, itching, and scar quality, as well as economic outcomes including cost per quality-adjusted life year (QALY), direct medical costs, and indirect costs such as absenteeism and reduced productivity. The findings will help guide health policy and resource allocation for advanced burn rehabilitation treatments. Participants aged 18 to 65 with hypertrophic scars at least 6 months after a burn injury will be randomly assigned to one of two groups. The experimental group will receive ESWT weekly for 8 weeks alongside a rehabilitation program involving physical therapy, scar management exercises, and patient education. The control group will receive the standard rehabilitation therapy alone, which includes physical, occupational, and scar-specific therapies, matched in frequency and duration to the experimental group but without ESWT. During the study, participants will be assessed at baseline and at 1, 3, and 6 months after treatment. Evaluations will include measures of pain using a Visual Analog Scale, itching with the Itch Man Scale, and scar quality using the Vancouver Scar Scale. Researchers will also monitor costs related to therapy sessions, equipment, hospital visits, and work productivity. This comprehensive follow-up will provide both clinical and economic data over a 6-month period to understand the impact of combining ESWT with rehabilitation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years
  • Documented hypertrophic scars following a burn injury, stable for at least 6 months
  • Moderate to severe scar severity measured by a standardized clinical assessment
  • Experiencing significant pain and/or itching related to the scar, with a baseline pain score of 4 or higher on a Visual Analog Scale
  • Able to provide informed consent and comply with study procedures
  • Employed or engaged in daily activities to allow measurement of indirect costs such as absenteeism or reduced productivity
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women
  • Previous surgical scar revision or invasive scar treatments within the last 6 months
  • Comorbid conditions like severe cardiovascular disease or uncontrolled diabetes that may interfere with treatment
  • Active skin infection at the scar site
  • Use of other investigational therapies for scar management

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants receive either extracorporeal shock wave therapy combined with standard rehabilitation or standard rehabilitation therapy alone for managing post-burn scars.

Weekly visits for treatment sessions

Follow-up

Duration - 6 months

Participants are monitored to assess pain intensity, pruritus, scar quality, and economic outcomes at multiple timepoints after completing treatment.

Visits at 1 month, 3 months, and 6 months post-intervention

Trial Site Locations

Total: 1 location

1

Faculty of Physical Therapy, Al Hayah University

Cairo, Egypt, 12311

Actively Recruiting

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Research Team

I

Ibrahim Zoheiry, Ph.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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