Comparative Study Between Botulinum Toxin-A Injection and Shock Waves on Hypertrophic Scars in Hand-burned Children

Cairo University (CU)

Status: Enrolling

Conditions: Hand-burned Children

Treatments: Other: shock wave therapy in addition to physical therapy program; Other: physical therapy treatment; Other: Botulinum toxin-A injection in addition to physical therapy program

Study type: Interventional

Funder types: Other

Identifiers

NCT06174155

P.T.REC/012/004732

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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),

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Control group

Active Comparator group

Description:

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.

Treatment:

Other: physical therapy treatment

Study group A

Active Comparator group

Description:

The study group A will receive Botulinum toxin-A injection in addition to physical therapy program as control group

Treatment:

Other: Botulinum toxin-A injection in addition to physical therapy program

Study group B

Active Comparator group

Description:

The study group B will receive shock wave therapy in addition to physical therapy program as control group.

Treatment:

Other: shock wave therapy in addition to physical therapy program