Evaluating the effectiveness of shock wave therapy combined with rehabilitation for post-burn scars
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
NA · Al Hayah University In Cairo · NCT06913257
This study is testing whether combining shock wave therapy with regular rehabilitation can help adults with thick scars from burns feel better and improve their scar quality compared to just rehabilitation alone.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Al Hayah University In Cairo (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06913257 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial evaluates the cost-effectiveness of extracorporeal shock wave therapy (ESWT) combined with standard rehabilitation compared to rehabilitation alone for adults with hypertrophic post-burn scars. The study will measure clinical outcomes such as pain intensity, pruritus, and scar quality, alongside economic outcomes like cost per quality-adjusted life year (QALY) gained. Participants aged 18-65 with stable hypertrophic scars will be randomized into two groups to assess the benefits of the combined treatment over standard care. Data will be collected at baseline and follow-up visits at 1, 3, and 6 months post-intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with documented hypertrophic scars from burn injuries that have been stable for at least 6 months.
Not a fit: Patients with comorbid conditions that interfere with treatment or those who have had recent invasive scar treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of post-burn scars, enhancing patients' quality of life and reducing healthcare costs.
How similar studies have performed: While ESWT has shown promise in enhancing scar maturation, this specific cost-effectiveness evaluation is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cairo
- Faculty of Physical Therapy, Al Hayah University — Cairo, Egypt (RECRUITING)
Study contacts
- Study coordinator: Ibrahim Zoheiry, Ph.D
- Email: ibrahim.alzoheiry@hotmail.com
- Phone: 01277774949
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertrophic Scar