Botulinum Toxin-A Injection and Shock Waves on Hypertrophic Scars in Hand-burned Children
概览
- 阶段
- 不适用
- 干预措施
- physical therapy treatment
- 疾病 / 适应症
- Hand-burned Children
- 发起方
- Cairo University
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Electronic goniometer
- 状态
- 已完成
- 最后更新
- 2个月前
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.
研究者
Reham Saeed Alsakhawi
Assistant Professor
Cairo University
入排标准
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
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
Study group A
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
Study group B
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
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.