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临床试验/NCT06174155
NCT06174155已完成不适用

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

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Electronic goniometer

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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),

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: physical therapy treatment (Other)

Study group A

Active Comparator

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

干预措施: Botulinum toxin-A injection in addition to physical therapy program (Other)

Study group B

Active Comparator

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

干预措施: shock wave therapy in addition to physical therapy program (Other)

结局指标

主要结局

Electronic goniometer

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Reham Saeed Alsakhawi

Assistant Professor

Cairo University

研究点 (1)

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