Hypertrophic ScarNCT06913257
Cost-Effectiveness of ESWT Plus Rehabilitation vs Rehabilitation Alone in Post-Burn Scars
A study testing ESWT Combined with Standard Rehabilitation and Standard Rehabilitation Therapy Alone in people with Hypertrophic Scar, run by Al Hayah University In Cairo at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertrophic Scar
- What is being tested?
- ESWT Combined with Standard Rehabilitation and Standard Rehabilitation Therapy Alone
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Apr 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Al Hayah University
Cairo, 12311
Mohamed ElMeligie, Ph.D, 01159880001 ext. +20, mohamed.elmeligie@ahuc.edu.eg
About this study
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
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.
Read the 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.
- Conditions
- Hypertrophic Scar
- Being tested
- ESWT Combined with Standard Rehabilitation, Standard Rehabilitation Therapy Alone
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWT Combined with Standard RehabilitationDevice
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.
Standard Rehabilitation Therapy AloneBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ESWT Plus Standard Rehabilitation | Experimental | 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. Receives: Device: ESWT Combined with Standard Rehabilitation |
| Standard Rehabilitation Alone | Active comparator | 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. Receives: Behavioral: Standard Rehabilitation Therapy Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (Visual Analog Scale [VAS])
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.
Measured: Assessed at baseline, 1 month, 3 months, and 6 months post-intervention.
Cost per Quality-Adjusted Life Year (QALY) Gained
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.
Measured: Evaluated at 6 months post-intervention.
Secondary outcomes (4)
Pruritus Intensity (Itch Man Scale)
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.
Measured: Measured at baseline, 1 month, 3 months, and 6 months post-intervention.
Scar Quality (Vancouver Scar Scale [VSS])
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.
Measured: Assessed at baseline, 1 month, 3 months, and 6 months post-intervention.
Direct Medical Costs
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.
Measured: Collated over the 6-month study period.
Indirect Costs (Absenteeism and Reduced Productivity)
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.
Measured: Evaluated cumulatively over the 6-month follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start22 Apr 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al Hayah University In Cairo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913257
- Sponsor's protocol ID
- ESWT-BurnCE2025
- Status last verified
- Mar 2025
- First submitted
- 30 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06913257
- Acronym / sponsor ID
- ESWT-BurnCE2025
- Conditions
- Hypertrophic Scar
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Al Hayah University In CairoUniversity, hospital or other
- Study start
- 22 Apr 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ESWT Plus Standard Rehabilitation | Experimental | Device: ESWT Combined with Standard RehabilitationParticipants 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. |
| Standard Rehabilitation Alone | Active comparator | Behavioral: Standard Rehabilitation Therapy AloneParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESWT Combined with Standard RehabilitationParticipants 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. | Device | ESWT Plus Standard Rehabilitation |
| Standard Rehabilitation Therapy AloneParticipants 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. | Behavioural | Standard Rehabilitation Alone |
Primary outcome
Pain Intensity (Visual Analog Scale [VAS])
Time frame: Assessed at baseline, 1 month, 3 months, and 6 months post-intervention.
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.
Cost per Quality-Adjusted Life Year (QALY) Gained
Time frame: Evaluated at 6 months post-intervention.
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.
4 secondary outcomes
Pruritus Intensity (Itch Man Scale)
Time frame: Measured at baseline, 1 month, 3 months, and 6 months post-intervention.
Scar Quality (Vancouver Scar Scale [VSS])
Time frame: Assessed at baseline, 1 month, 3 months, and 6 months post-intervention.
Direct Medical Costs
Time frame: Collated over the 6-month study period.
Indirect Costs (Absenteeism and Reduced Productivity)
Time frame: Evaluated cumulatively over the 6-month follow-up period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESWT Combined with Standard Rehabilitation and Standard Rehabilitation Therapy Alone in people with Hypertrophic Scar, run by Al Hayah University In Cairo at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Zoheiry, Ph.D (01277774949 ext. +20, ibrahim.alzoheiry@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (Visual Analog Scale [VAS]) (time frame: Assessed at baseline, 1 month, 3 months, and 6 months post-intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.