Burn ScarNCT07234305
Shock Wave Therapy Versus Conventional Physical Therapy for Partial- Thickness Forearm Burn Scars
A study testing Shock wave and Traditional Physical Therapy in people with Burn Scar and Burns, run by MTI University at 1 site in Egypt.
Trial summary
Burn injuries can lead to significant physical and psychological challenges, particularly when they result in scarring. Burn scars can lead to a variety of complications that significantly impact a patient's quality of life1. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- What is being tested?
- Shock wave and Traditional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 4 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adults diagnosed with partial thickness burns on the forearm,
- scars that had been present for a minimum of six months,
- participants capable of providing informed consent
Who cannot join
- hypersensitivity to shock wave therapy,
- active infections at the burn site,
- neurological disorders that could impact sensation,
- any contraindications that would prevent the use of ultrasonography.
Trial locations and contacts
1 site in 1 country.
About this study
Burn injuries can lead to significant physical and psychological challenges, particularly when they result in scarring. Burn scars can lead to a variety of complications that significantly impact a patient's quality of life1.
Physical complications often include restricted range of motion and contractures, which can hinder mobility and daily activities, especially if the scars are located near joints2. Additionally, psychosocial effects such as anxiety, depression, and social withdrawal may arise due to the visible nature of scars and the stigma associated with them3.
Read more
Functional complications can also manifest, affecting the skin's ability to regulate temperature and moisture, increasing susceptibility to infections, and causing discomfort or pain 4. In some cases, burn scars may develop into hypertrophic scars or keloids, leading to further aesthetic concerns and potential need for medical interventions5.
Among the various types of burns, partial thickness burns are particularly concerning due to their potential for hypertrophic scarring and functional limitations6. Effective treatment strategies are essential to manage these scars, promote healing, and improve the quality of life for affected individuals7.
Read the detailed description
Ultrasonography has emerged as a valuable tool in the assessment and monitoring of scar tissue characteristics, allowing for non-invasive evaluation of tissue composition, vascularity, and changes over time. This imaging modality provides critical insights into the healing process, facilitating more informed therapeutic decisions8.
Shock wave therapy has gained attention in recent years as a novel treatment option for scar management. It utilizes acoustic waves to stimulate tissue regeneration, enhance blood flow, and promote collagen remodeling, potentially leading to improved scar quality9.
In contrast, traditional physical therapy remains a cornerstone of rehabilitation post-burn, focusing on restoring function, reducing pain, and improving mobility through various modalities, including stretching, strengthening, and manual therapy techniques 10.
This research addresses the limited exploration of the comparative effectiveness of shock wave therapy versus traditional physical therapy in treating partial thickness burn scars on the forearm. By utilizing a prospective randomized clinical trial design, the study aims to provide substantial evidence regarding the efficacy of these two treatment modalities. The primary focus is to evaluate the impact of both therapies on scar characteristics, specifically examining changes in echogenicity, vascularity, and overall morphology through ultrasonography before and after treatment. Additionally, the study seeks to compare patient-reported outcomes related to scar appearance, pain, and functional abilities between the two groups, ultimately contributing to the development of improved treatment protocols for burn scars.
- Being tested
- Shock wave, Traditional Physical Therapy
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shock waveOther
The treatment regimen will include2000 shocks directed to the 10 cm2 scar tissue itself, 1000 shocks to the surrounding soft tissue to promote healing. Pneumatic extracorporeal shock wave therapy (ESWT) will administered using the EME Srl device (Via Degli Abeti, Pesaro- Italy) over a series of sessions. Patients received two sessions each week for 8 successive weeks
Traditional Physical TherapyOther
This included five minutes of passive stretching for the wrist flexors, with therapist assistance, followed by five minutes of active stretching, encouraging patients to engage in movements independently to enhance flexibility and alleviate stiffness. To rebuild strength and functionality in the forearm and hand, the regimen incorporated progressive resistance exercises such as wrist flexion and extension, performed for 20 repetitions per set, two sets per session, three times weekly, using light weights (Vinyl Dumbbell Set, Soft Grips - 2kg, progressing to 3kg, made in China). Grip strengthening exercises were also included, utilizing a guitar finger exercise grip (made in China), with 30 repetitions per set, two sets per day, three times a week.
| Study group | Role | What they receive |
|---|---|---|
| Shock wave | Experimental | The treatment regimen included 2000 shocks directed to the 10 cm2 scar tissue itself, 1000 shocks to the surrounding soft tissue to promote healing. Pneumatic extracorporeal shock wave therapy (ESWT) will administered using the EME Srl device (Via Degli Abeti, Pesaro- Italy) over a series of sessions Receives: Other: Shock wave |
| Traditional Physical Therapy | Experimental | This included five minutes of passive stretching for the wrist flexors, with therapist assistance, followed by five minutes of active stretching, encouraging patients to engage in movements independently to enhance flexibility and alleviate stiffness. To rebuild strength and functionality in the forearm and hand, the regimen incorporated progressive resistance exercises such as wrist flexion and extension, performed for 20 repetitions per set, two sets per session, three times weekly, using light weights (Vinyl Dumbbell Set, Soft Grips - 2kg, progressing to 3kg, made in China). Grip strengthening exercises were also included, utilizing a guitar finger exercise grip (made in China), with 30 repetitions per set, two sets per day, three times a week. Receives: Other: Traditional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonography Assessment
High-resolution ultrasound was performed using the GE Logiq P6 Pro (GE Healthcare, Solingen, Germany) machine, to measure scars during the pre-treatment, post-treatment, and follow-up periods. Scar thickness is determined at the thickest point of irregular scars
Measured: at baseline , at 8 weeks and 8 weeks follow up
The Vancouver Scar Scale
The total score can range from 0 to 13, where a score of zero indicates normal skin and a score of 13 reflects the most worse scar tissue. In this study, the VSS was utilized to assess forearm scars in participants at baseline before any interventions, again after 8 weeks of treatment, and finally 8 weeks post-intervention to monitor changes over time12.
Measured: at baseline, at 8 weeks and 8 weeks follow up
Secondary outcomes (1)
The Burn Specific Health Scale-Brief (BSHS-B)
The questionnaire is divided into nine sub-domains, which cover areas such as emotional well-being, basic abilities, employment, social interactions, heat sensitivity, sexual health, treatment processes, self-image, and upper limb functionality. Respondents use a 5-point Likert scale to indicate the level of difficulty or impact related to their burn experiences. The BSHS-B effectively captures the complexities of recovery and distress following burns. BSHS-B was utilized to assess forearm scars in participants at baseline before any interventions, again after 8 weeks of treatment, and finally 8 weeks' post-intervention to monitor changes over time13.
Measured: at baseline , at 8 weeks and 8 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Oct 2025
- Primary completion1 Feb 2026
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn 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
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234305
- Sponsor's protocol ID
- IRB00014233-52
- Status last verified
- Feb 2026
- First submitted
- 14 Nov 2025
- Last updated
- 12 Feb 2026
- Results posted
- 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shock Wave Therapy Versus Conventional Physical Therapy for Partial- Thickness Forearm Burn Scars
- ClinicalTrials.gov ID
- NCT07234305
- Acronym / sponsor ID
- IRB00014233-52
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 18 Nov 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.
Burn injuries can lead to significant physical and psychological challenges, particularly when they result in scarring. Burn scars can lead to a variety of complications that significantly impact a patient's quality of life1.
Physical complications often include restricted range of motion and contractures, which can hinder mobility and daily activities, especially if the scars are located near joints2. Additionally, psychosocial effects such as anxiety, depression, and social withdrawal may arise due to the visible nature of scars and the stigma associated with them3.
Functional complications can also manifest, affecting the skin's ability to regulate temperature and moisture, increasing susceptibility to infections, and causing discomfort or pain 4. In some cases, burn scars may develop into hypertrophic scars or keloids, leading to further aesthetic concerns and potential need for medical interventions5.
Among the various types of burns, partial thickness burns are particularly concerning due to their potential for hypertrophic scarring and functional limitations6. Effective treatment strategies are essential to manage these scars, promote healing, and improve the quality of life for affected individuals7.
Detailed description
Ultrasonography has emerged as a valuable tool in the assessment and monitoring of scar tissue characteristics, allowing for non-invasive evaluation of tissue composition, vascularity, and changes over time. This imaging modality provides critical insights into the healing process, facilitating more informed therapeutic decisions8.
Shock wave therapy has gained attention in recent years as a novel treatment option for scar management. It utilizes acoustic waves to stimulate tissue regeneration, enhance blood flow, and promote collagen remodeling, potentially leading to improved scar quality9.
In contrast, traditional physical therapy remains a cornerstone of rehabilitation post-burn, focusing on restoring function, reducing pain, and improving mobility through various modalities, including stretching, strengthening, and manual therapy techniques 10.
This research addresses the limited exploration of the comparative effectiveness of shock wave therapy versus traditional physical therapy in treating partial thickness burn scars on the forearm. By utilizing a prospective randomized clinical trial design, the study aims to provide substantial evidence regarding the efficacy of these two treatment modalities. The primary focus is to evaluate the impact of both therapies on scar characteristics, specifically examining changes in echogenicity, vascularity, and overall morphology through ultrasonography before and after treatment. Additionally, the study seeks to compare patient-reported outcomes related to scar appearance, pain, and functional abilities between the two groups, ultimately contributing to the development of improved treatment protocols for burn scars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Shock wave | Experimental | Other: Shock waveThe treatment regimen included 2000 shocks directed to the 10 cm2 scar tissue itself, 1000 shocks to the surrounding soft tissue to promote healing. Pneumatic extracorporeal shock wave therapy (ESWT) will administered using the EME Srl device (Via Degli Abeti, Pesaro- Italy) over a series of sessions |
| Traditional Physical Therapy | Experimental | Other: Traditional Physical TherapyThis included five minutes of passive stretching for the wrist flexors, with therapist assistance, followed by five minutes of active stretching, encouraging patients to engage in movements independently to enhance flexibility and alleviate stiffness. To rebuild strength and functionality in the forearm and hand, the regimen incorporated progressive resistance exercises such as wrist flexion and extension, performed for 20 repetitions per set, two sets per session, three times weekly, using light weights (Vinyl Dumbbell Set, Soft Grips - 2kg, progressing to 3kg, made in China). Grip strengthening exercises were also included, utilizing a guitar finger exercise grip (made in China), with 30 repetitions per set, two sets per day, three times a week. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- adults diagnosed with partial thickness burns on the forearm,
- scars that had been present for a minimum of six months,
- participants capable of providing informed consent
Key exclusion criteria (4 listed)
- hypersensitivity to shock wave therapy,
- active infections at the burn site,
- neurological disorders that could impact sensation,
- any contraindications that would prevent the use of ultrasonography.
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 |
|---|---|---|
| Shock waveThe treatment regimen will include2000 shocks directed to the 10 cm2 scar tissue itself, 1000 shocks to the surrounding soft tissue to promote healing. Pneumatic extracorporeal shock wave therapy (ESWT) will administered using the EME Srl device (Via Degli Abeti, Pesaro- Italy) over a series of sessions. Patients received two sessions each week for 8 successive weeks | Other | Shock wave |
| Traditional Physical TherapyThis included five minutes of passive stretching for the wrist flexors, with therapist assistance, followed by five minutes of active stretching, encouraging patients to engage in movements independently to enhance flexibility and alleviate stiffness. To rebuild strength and functionality in the forearm and hand, the regimen incorporated progressive resistance exercises such as wrist flexion and extension, performed for 20 repetitions per set, two sets per session, three times weekly, using light weights (Vinyl Dumbbell Set, Soft Grips - 2kg, progressing to 3kg, made in China). Grip strengthening exercises were also included, utilizing a guitar finger exercise grip (made in China), with 30 repetitions per set, two sets per day, three times a week. | Other | Traditional Physical Therapy |
Primary outcome
Ultrasonography Assessment
Time frame: at baseline , at 8 weeks and 8 weeks follow up
High-resolution ultrasound was performed using the GE Logiq P6 Pro (GE Healthcare, Solingen, Germany) machine, to measure scars during the pre-treatment, post-treatment, and follow-up periods. Scar thickness is determined at the thickest point of irregular scars
The Vancouver Scar Scale
Time frame: at baseline, at 8 weeks and 8 weeks follow up
The total score can range from 0 to 13, where a score of zero indicates normal skin and a score of 13 reflects the most worse scar tissue. In this study, the VSS was utilized to assess forearm scars in participants at baseline before any interventions, again after 8 weeks of treatment, and finally 8 weeks post-intervention to monitor changes over time12.
1 secondary outcome
The Burn Specific Health Scale-Brief (BSHS-B)
Time frame: at baseline , at 8 weeks and 8 weeks follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Burn Scar
Not yet recruitingObservational study
Recurrence of Extremity Joint Contracture After Z-Plasty Versus Full-Thickness Skin Graft
Joint Contracture, Contracture
RecruitingPhase 3
Novel Strategies for Reducing Burn Scar Itch
Burn Scar, Itch Scarring
RecruitingPhase 2/3
Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients
Burn Scar, Burn Wound
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Tools for Return of Facial Function
Facial Scarring, Facial Trauma
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shock wave and Traditional Physical Therapy in people with Burn Scar and Burns, run by MTI University 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 12 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonography Assessment (time frame: at baseline , at 8 weeks and 8 weeks follow up). 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 12 Feb 2026.