Hand-burned ChildrenNCT06174155
Comparative Study Between Botulinum Toxin-A Injection and Shock Waves on Hypertrophic Scars in Hand-burned Children
A study testing physical therapy treatment, Botulinum toxin-A injection in addition to physical therapy program and shock wave therapy in addition to physical therapy program in people with Hand-burned Children, run by Cairo University at 1 site in Egypt.
Trial summary
PURPOSE: The study aims to compare study between Botulinum toxin-A injection and shock waves therapy on hypertrophic scars in hand-burned children. BACKGROUND: Burn injuries can cause significant physical and psychological distress, especially when they result in hypertrophic scarring. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Hand-burned Children
- What is being tested?
- physical therapy treatment, Botulinum toxin-A injection in addition to physical therapy program and shock wave therapy in addition to physical therapy program
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2023to 20 Jun 2025
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age will range from 6-18 years
- Diagnosed with hypertrophic scars resulting from hand burns.
- Has burn injuries caused by flame, scald or chemical agents.
- With a total body surface area (TBSA) varied from 10 to 30%
- A resistant partial or complete loss of wrist flexion attributable to wrist flexor contracture
- After wound and skin graft healing (~ 90 days post-surgery),
Who cannot join
- Children with underlying medical conditions that could interfere with scar healing or treatment outcomes
- Skin flap surgery, malignancies, cardiac arrhythmias, pacemaker implantation, coagulopathies, fractures about the treatment area, articular adhesions, and psychiatric co-morbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Botulinum Toxin-A Injection and Shock Waves on Hypertrophic Scars in Hand-burned Children
PURPOSE: The study aims to compare study between Botulinum toxin-A injection and shock waves therapy on hypertrophic scars in hand-burned children.
BACKGROUND: Burn injuries can cause significant physical and psychological distress, especially when they result in hypertrophic scarring. In children, who are particularly vulnerable to these injuries, it is important to accurately assess the severity of these scars and their impact on functionality.
HYPOTHESES: There is no significant difference between the combined effect of the traditional physical therapy program with botulinum toxin-A injection and the traditional physical therapy program with shock waves therapy on improving wrist extension, ulnar deviation, radial deviation, hand grip strength, and severity of the scar on hypertrophic scars in hand-burned children.
- Conditions
- Hand-burned Children
- Being tested
- physical therapy treatment, Botulinum toxin-A injection in addition to physical therapy program, shock wave therapy in addition to physical therapy program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapy treatmentOther
The control group will receive the physical therapy program and conduct five times per week over four consecutive weeks under the supervision of a physical rehabilitation specialist. The primary focus of the program was to improve scar malleability, lengthen muscles and tendons, enhance joint mobility, and to restore functionality. Each session lasted almost for 45 minutes and consisted of therapeutic paraffin application; deep tissue massaging (5 minutes); stretching exercises; active ROM exercises.
Botulinum toxin-A injection in addition to physical therapy programOther
Two injection procedures will be used. The first is an EMG-guided BTX-A administration (Botox®, Allergan PLC, Dublin, Ireland) that will be localized to the motor endplate zone of the wrist flexors, radial and ulnar deviators. The second is a meso-injection procedure, where the BTX-A will be injected subdermal, intradermal, and into the scar (around the periphery and into the center).
shock wave therapy in addition to physical therapy programOther
After wound and skin graft healing (~ 90 days post-surgery), the unfocused shockwave will be applied to the site of burn injury on the volar aspect of the hand of the subjects and will allocate to the shock wave therapy intervention arm. The treatment will be delivered using a portable shockwave device (Zimmer enPuls, EMS physio Ltd, Germany).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The control group will receive the physical therapy program and conduct five times per week over four consecutive weeks under the supervision of a physical rehabilitation specialist. Receives: Other: physical therapy treatment |
| Study group A | Active comparator | The study group A will receive Botulinum toxin-A injection in addition to physical therapy program as control group Receives: Other: Botulinum toxin-A injection in addition to physical therapy program |
| Study group B | Active comparator | The study group B will receive shock wave therapy in addition to physical therapy program as control group. Receives: Other: shock wave therapy in addition to physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electronic goniometer
to assess the range of motions of wrist extension, radial deviation, and ulnar deviation. Active ROM Measurement: the patient independently moving their affected joint. The device records the joint angle throughout the movement, allowing for a thorough assessment of functional limitations caused by hypertrophic scars. Passive ROM Measurement: the therapist moves the patient's joint through its range of motion while the electronic goniometer measures and records the joint angles. This approach provides valuable information about the degree of movement restriction due to hypertrophic scarring.
Measured: 3 months
Hand grip Dynamometer
for hand grip strength is used for assessing upper limb impairment, work capacity following injury or disease, and rehabilitation progression and/or potential following injury or surgery. For each child, the maximal voluntary contraction was determined as the highest of three contractions (INITIAL MAX). After a one-minute rest period, children will be instructed to squeeze the dynamometer in a static contraction at a level of 50% maximal for as long as possible, the duration of which will be recorded (DURATION). The level of static contraction will be monitored by the assessor who provided verbal feedback to ensure that a level of 50% maximal was maintained. Children must perform an additional post-fatigue maximal contraction within 10 seconds of completing the 50% maximal static contraction (FINAL MAX).
Measured: 3 months
Vancouver scar scale
It employs four main parameters to evaluate hypertrophic scars: vascularity, pigmentation, pliability, and height. These parameters are individually scored on a scale ranging from 0 to 3, with higher scores indicating greater severity. The scores are then summed to provide an overall measure of scar severity, ranging from 0 (normal skin) to 14 (most severe scar). To ensure accurate evaluations, it is recommended to have adequate lighting, a calm environment, and reliable observers trained in using the VSS. Evaluators carefully assess each parameter, considering factors such as erythema, texture, and skin tension to assign appropriate scores. Finally, the total score provides a comprehensive representation of the hypertrophic scar's severity.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start15 Dec 2023
- Primary completion5 Mar 2024
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand-burned ChildrenStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Saeed Alsakhawi, Cairo University
- Investigators
- Reham Alsakhawi, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174155
- Sponsor's protocol ID
- P.T.REC/012/004732
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin-A Injection and Shock Waves on Hypertrophic Scars in Hand-burned Children
- ClinicalTrials.gov ID
- NCT06174155
- Acronym / sponsor ID
- P.T.REC/012/004732
- Conditions
- Hand-burned Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 18 Dec 2023 (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.
PURPOSE: The study aims to compare study between Botulinum toxin-A injection and shock waves therapy on hypertrophic scars in hand-burned children.
BACKGROUND: Burn injuries can cause significant physical and psychological distress, especially when they result in hypertrophic scarring. In children, who are particularly vulnerable to these injuries, it is important to accurately assess the severity of these scars and their impact on functionality.
HYPOTHESES: There is no significant difference between the combined effect of the traditional physical therapy program with botulinum toxin-A injection and the traditional physical therapy program with shock waves therapy on improving wrist extension, ulnar deviation, radial deviation, hand grip strength, and severity of the scar on hypertrophic scars in hand-burned children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: physical therapy treatmentThe control group will receive the physical therapy program and conduct five times per week over four consecutive weeks under the supervision of a physical rehabilitation specialist. |
| Study group A | Active comparator | Other: Botulinum toxin-A injection in addition to physical therapy programThe study group A will receive Botulinum toxin-A injection in addition to physical therapy program as control group |
| Study group B | Active comparator | Other: shock wave therapy in addition to physical therapy programThe study group B will receive shock wave therapy in addition to physical therapy program as control group. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age will range from 6-18 years
- Diagnosed with hypertrophic scars resulting from hand burns.
- Has burn injuries caused by flame, scald or chemical agents.
- With a total body surface area (TBSA) varied from 10 to 30%
- A resistant partial or complete loss of wrist flexion attributable to wrist flexor contracture
Key exclusion criteria (2 listed)
- Children with underlying medical conditions that could interfere with scar healing or treatment outcomes
- Skin flap surgery, malignancies, cardiac arrhythmias, pacemaker implantation, coagulopathies, fractures about the treatment area, articular adhesions, and psychiatric co-morbidities
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 |
|---|---|---|
| physical therapy treatmentThe control group will receive the physical therapy program and conduct five times per week over four consecutive weeks under the supervision of a physical rehabilitation specialist. The primary focus of the program was to improve scar malleability, lengthen muscles and tendons, enhance joint mobility, and to restore functionality. Each session lasted almost for 45 minutes and consisted of therapeutic paraffin application; deep tissue massaging (5 minutes); stretching exercises; active ROM exercises. | Other | Control group |
| Botulinum toxin-A injection in addition to physical therapy programTwo injection procedures will be used. The first is an EMG-guided BTX-A administration (Botox®, Allergan PLC, Dublin, Ireland) that will be localized to the motor endplate zone of the wrist flexors, radial and ulnar deviators. The second is a meso-injection procedure, where the BTX-A will be injected subdermal, intradermal, and into the scar (around the periphery and into the center). | Other | Study group A |
| shock wave therapy in addition to physical therapy programAfter wound and skin graft healing (~ 90 days post-surgery), the unfocused shockwave will be applied to the site of burn injury on the volar aspect of the hand of the subjects and will allocate to the shock wave therapy intervention arm. The treatment will be delivered using a portable shockwave device (Zimmer enPuls, EMS physio Ltd, Germany). | Other | Study group B |
Primary outcome
Electronic goniometer
Time frame: 3 months
to assess the range of motions of wrist extension, radial deviation, and ulnar deviation. Active ROM Measurement: the patient independently moving their affected joint. The device records the joint angle throughout the movement, allowing for a thorough assessment of functional limitations caused by hypertrophic scars. Passive ROM Measurement: the therapist moves the patient's joint through its range of motion while the electronic goniometer measures and records the joint angles. This approach provides valuable information about the degree of movement restriction due to hypertrophic scarring.
Hand grip Dynamometer
Time frame: 3 months
for hand grip strength is used for assessing upper limb impairment, work capacity following injury or disease, and rehabilitation progression and/or potential following injury or surgery. For each child, the maximal voluntary contraction was determined as the highest of three contractions (INITIAL MAX). After a one-minute rest period, children will be instructed to squeeze the dynamometer in a static contraction at a level of 50% maximal for as long as possible, the duration of which will be recorded (DURATION). The level of static contraction will be monitored by the assessor who provided verbal feedback to ensure that a level of 50% maximal was maintained. Children must perform an additional post-fatigue maximal contraction within 10 seconds of completing the 50% maximal static contraction (FINAL MAX).
Vancouver scar scale
Time frame: 3 months
It employs four main parameters to evaluate hypertrophic scars: vascularity, pigmentation, pliability, and height. These parameters are individually scored on a scale ranging from 0 to 3, with higher scores indicating greater severity. The scores are then summed to provide an overall measure of scar severity, ranging from 0 (normal skin) to 14 (most severe scar). To ensure accurate evaluations, it is recommended to have adequate lighting, a calm environment, and reliable observers trained in using the VSS. Evaluators carefully assess each parameter, considering factors such as erythema, texture, and skin tension to assign appropriate scores. Finally, the total score provides a comprehensive representation of the hypertrophic scar's severity.
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 4 Feb 2026.
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.
Reham Alsakhawi principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy treatment, Botulinum toxin-A injection in addition to physical therapy program and shock wave therapy in addition to physical therapy program in people with Hand-burned Children, run by Cairo 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 6 inclusion and 2 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 4 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?
Electronic goniometer (time frame: 3 months). The study lists 3 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 4 Feb 2026.