Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-26 @ 7:21 PM
Study NCT ID:
NCT06913257
Status:
RECRUITING
Last Update Posted:
2025-04-06
First Post:
2025-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cost-Effectiveness of ESWT Plus Rehabilitation vs Rehabilitation Alone in Post-Burn Scars
Sponsor:
Al Hayah University In Cairo
Organization:
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: