Post Burn Cubital Tunnel Syndrome Response to High Intensity Laser Therapy Versus Shock Wave Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Nerve Conduction Studies of ulnar nerve
研究概览
简要总结
Post-burn cubital tunnel syndrome is a disabling complication that may occur after upper-limb burns involving the elbow due to edema, scar formation, and tissue compression around the ulnar nerve. This randomized controlled trial compared the additive effects of high-intensity laser therapy (HILT) and extracorporeal shock wave therapy (ESWT), when combined with ulnar nerve gliding exercises, on electrophysiological parameters and upper-limb function in adults with clinically and electrophysiologically confirmed unilateral post-burn cubital tunnel syndrome following healed second- or third-degree burns.
详细描述
Peripheral nerve entrapment is a recognized complication of burn injuries. Following second- or third-degree burns involving the elbow, edema, scar tissue formation, and tissue contracture may contribute to compression of the ulnar nerve within the cubital tunnel. Patients with post-burn cubital tunnel syndrome commonly experience pain, paresthesia, sensory disturbances, and impaired upper-limb function. Cubital tunnel syndrome is the second most common entrapment neuropathy of the upper extremity after carpal tunnel syndrome.
Given the limited evidence regarding conservative management of post-burn cubital tunnel syndrome, this assessor-blinded, parallel-group randomized controlled trial evaluated the effects of high-intensity laser therapy (HILT) and extracorporeal shock wave therapy (ESWT), each combined with ulnar nerve gliding exercises, compared with ulnar nerve gliding exercises alone. The study assessed changes in motor nerve conduction velocity, compound muscle action potential amplitude, and upper-limb function in adults aged 20-50 years with healed unilateral second- or third-degree upper-limb burns involving the elbow and clinically and electrophysiologically confirmed unilateral post-burn cubital tunnel syndrome.
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 (Outcomes Assessor)
盲法说明
Due to the distinct tactile and visible nature of the electrophysical modalities, true patient and therapist blinding was not feasible after the interventions commenced. However, to mitigate potential expectation bias, participants were framed to understand that the study was evaluating the comparative clinical outcomes of different advanced rehabilitation approaches and were not informed which intervention was hypothesized to be superior.
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 20-50 years.
- •Healed unilateral second- or third-degree upper-limb burns involving the elbow with a total body surface area (TBSA) <20%.
- •Unilateral post-burn cubital tunnel syndrome confirmed clinically (including Tinel's sign) and electrophysiologically by focal slowing of ulnar nerve conduction across the elbow.
- •Ability and willingness to provide informed consent and comply with the study protocol.
排除标准
- •Severe axonal loss indicating direct ulnar nerve injury.
- •Generalized neuropathy or abnormal nerve conduction in the contralateral upper limb.
- •Concurrent median or radial neuropathy or brachial plexus injury.
- •Previous elbow fracture, ulnar nerve surgery, or extensive reconstructive procedures around the cubital tunnel (simple skin grafting permitted).
- •Diabetes mellitus, active malignancy, pregnancy, active infection, coagulopathy, or cardiac pacemaker implantation.
- •Other neurological disorders affecting upper-limb function.
- •Participation in another rehabilitation or interventional study during the study period.
- •Inability to adhere to the treatment protocol or scheduled assessments.
研究组 & 干预措施
High intensity laser therapy
Device: High intensity laser therapy 25 Patients
干预措施: High intensity laser therapy (Device)
High intensity laser therapy
Device: High intensity laser therapy 25 Patients
干预措施: Ulnar nerve gliding exercises. (Other)
Shock Wave therapy
Extracorporeal shock wave therapy, 25 patients
干预措施: Shock Wave therapy (Device)
Shock Wave therapy
Extracorporeal shock wave therapy, 25 patients
干预措施: Ulnar nerve gliding exercises. (Other)
Ulnar nerve gliding exercises.
Ulnar nerve gliding exercises, 25 patients
干预措施: Ulnar nerve gliding exercises. (Other)
结局指标
主要结局
Nerve Conduction Studies of ulnar nerve
时间窗: Baseline and 4 weeks
Nerve conduction studies will assess the function/integrity of the ulnar nerve. Patients will be evaluated at base line before treatment and after completion of treatment using Neuropack S1MEB-9004 NIHON KODEN, JAPAN for measuring the motor conduction velocity of the ulnar nerve.
Nerve Conduction Studies of ulnar nerve
时间窗: Baseline, 4 week and 12 week
Ulnar nerve conduction studies were performed according to AAEM guidelines and reported in line with the TIDieR checklist. Diagnosis of cubital tunnel syndrome (CBTS) was confirmed using motor nerve conduction velocity (NCV) and compound muscle action potential (CMAP) of the ulnar nerve across the elbow. Assessments were conducted using a Neuropack S1 MEB-9004 (Nihon Kohden, Japan) by a certified electrophysiologist. CMAPs were recorded from the abductor digiti minimi with standardized patient positioning, and the ulnar nerve was stimulated at the wrist, below and above the elbow. Studies were performed at baseline and after 4 weeks and follow up after 12 weeks in a temperature-controlled lab (25°C). NCV was calculated from distance and latency differences, while CMAP amplitude and latency were recorded to evaluate nerve function and treatment outcomes.
次要结局
- The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire(Baseline and 4 weeks)
- The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire(Baseline, 4 week and 12 week)
研究者
Mahmoud H Mohamed, PhD
Associate Professor
Ahram Canadian University