Comparative Study Between Botulinum Toxin-A Injection and Shock Waves on Hypertrophic Scars in Hand-burned Children
NCT ID: NCT06174155
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
60 participants
INTERVENTIONAL
2023-12-15
2026-01-20
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group
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.
physical therapy treatment
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.
Study group A
The study group A will receive Botulinum toxin-A injection in addition to physical therapy program as control group
Botulinum toxin-A injection in addition to physical therapy program
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).
Study group B
The study group B will receive shock wave therapy in addition to physical therapy program as control group.
shock wave therapy in addition to physical therapy program
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).
Interventions
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physical therapy treatment
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 program
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 program
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).
Eligibility Criteria
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Inclusion Criteria
* 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),
Exclusion Criteria
* Skin flap surgery, malignancies, cardiac arrhythmias, pacemaker implantation, coagulopathies, fractures about the treatment area, articular adhesions, and psychiatric co-morbidities
6 Years
18 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Reham Saeed Alsakhawi
Assistant Professor
Principal Investigators
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Reham Alsakhawi
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor
Locations
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Reham Alsakhawi
Giza, , Egypt
Countries
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Other Identifiers
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P.T.REC/012/004732
Identifier Type: -
Identifier Source: org_study_id