Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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