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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017439', 'term': 'Cicatrix, Hypertrophic'}], 'ancestors': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'While participants, care providers, and investigators will be aware of the intervention provided, outcome assessors and the economic evaluation team will remain blinded to group allocation to reduce bias in outcome measurement and cost data analysis.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants with post-burn hypertrophic scars will be randomized into two parallel arms. Stratified randomization based on scar severity ensures balanced allocation across groups. Each participant will receive a predetermined intervention and be followed for 6 months to assess changes in both clinical parameters and economic outcomes.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-30', 'studyFirstSubmitDate': '2025-03-30', 'studyFirstSubmitQcDate': '2025-03-30', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity (Visual Analog Scale [VAS])', 'timeFrame': 'Assessed at baseline, 1 month, 3 months, and 6 months post-intervention.', 'description': '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.'}, {'measure': 'Cost per Quality-Adjusted Life Year (QALY) Gained', 'timeFrame': 'Evaluated at 6 months post-intervention.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Pruritus Intensity (Itch Man Scale)', 'timeFrame': 'Measured at baseline, 1 month, 3 months, and 6 months post-intervention.', 'description': '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.'}, {'measure': 'Scar Quality (Vancouver Scar Scale [VSS])', 'timeFrame': 'Assessed at baseline, 1 month, 3 months, and 6 months post-intervention.', 'description': '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.'}, {'measure': 'Direct Medical Costs', 'timeFrame': 'Collated over the 6-month study period.', 'description': '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.'}, {'measure': 'Indirect Costs (Absenteeism and Reduced Productivity)', 'timeFrame': 'Evaluated cumulatively over the 6-month follow-up period.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertrophic Scar']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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:\n\nArm 1 (Experimental): ESWT combined with standardized rehabilitation therapy. Arm 2 (Active Comparator): Standard rehabilitation therapy alone.\n\nPrimary 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\\]).\n\nEconomic 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).\n\nData will be collected at baseline and at follow-up visits at 1, 3, and 6 months post-intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults aged 18-65 years. Documented hypertrophic scars following a burn injury, with scars present and stable for at least 6 months.\n\nModerate to severe scar severity as measured by a standardized clinical assessment.\n\nExperiencing significant pain and/or pruritus related to the scar, with a baseline VAS score of ≥4.\n\nAble 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.\n\nExclusion Criteria:\n\nPregnant or lactating women. Individuals with previous surgical scar revision or other invasive scar treatments within the last 6 months.\n\nPatients with comorbid conditions (e.g., severe cardiovascular disease, uncontrolled diabetes) that could interfere with rehabilitation or ESWT.\n\nActive skin infection in the area of the scar. Use of concurrent investigational therapies for scar management.'}, 'identificationModule': {'nctId': 'NCT06913257', 'briefTitle': 'Cost-Effectiveness of ESWT Plus Rehabilitation vs Rehabilitation Alone in Post-Burn Scars', 'organization': {'class': 'OTHER', 'fullName': 'Al Hayah University In Cairo'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ESWT-BurnCE2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ESWT Plus Standard Rehabilitation', 'description': 'Participants in this arm will undergo extracorporeal shock wave therapy (ESWT) in addition to receiving standard rehabilitation therapy. ESWT will be administered using a standardized protocol, with treatment sessions conducted weekly for a predetermined duration, integrated with a rehabilitation program focused on scar management, functional restoration, and symptom relief.', 'interventionNames': ['Device: ESWT Combined with Standard Rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Rehabilitation Alone', 'description': 'Participants assigned to this arm will receive the standard rehabilitation therapy protocol designed for post-burn scar management. This regimen includes physical, occupational, and scar-specific therapy sessions delivered in a standardized fashion without the addition of ESWT.', 'interventionNames': ['Behavioral: Standard Rehabilitation Therapy Alone']}], 'interventions': [{'name': 'ESWT Combined with Standard Rehabilitation', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['ESWT Plus Standard Rehabilitation']}, {'name': 'Standard Rehabilitation Therapy Alone', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Standard Rehabilitation Alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12311', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed ElMeligie, Ph.D', 'role': 'CONTACT', 'email': 'mohamed.elmeligie@ahuc.edu.eg', 'phone': '01159880001', 'phoneExt': '+20'}], 'facility': 'Faculty of Physical Therapy, Al Hayah University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ibrahim Zoheiry, Ph.D', 'role': 'CONTACT', 'email': 'ibrahim.alzoheiry@hotmail.com', 'phone': '01277774949', 'phoneExt': '+20'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al Hayah University In Cairo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}