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

Cairo University (CU) logo

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

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

Trial contacts and locations

1

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Central trial contact

Reham Alsakhawi

Data sourced from clinicaltrials.gov

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