Effectiveness of Amniotic Membrane Combined With Secretome as an Adjunct to Carpal Tunnel Release Surgery: Evaluation Using the Boston Carpal Tunnel Questionnaire and Electromyography
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Boston Carpal Tunnel Questionnaire (BCTQ) score
研究概览
简要总结
Carpal Tunnel Syndrome (CTS) is a compressive neuropathy caused by chronic compression of the median nerve within the carpal tunnel, resulting in pain, numbness, tingling, and impaired hand function. This study is a randomized controlled trial with a pre- and post-intervention experimental design to evaluate the effectiveness of adjunctive amniotic membrane combined with secretome in patients with moderate-to-severe CTS undergoing carpal tunnel release surgery. Participants will be randomly assigned to receive either standard surgical treatment alone or surgery with the addition of amniotic membrane and secretome. Clinical and electrophysiological outcomes will be evaluated before surgery and at 3 weeks after the intervention using the Boston Carpal Tunnel Questionnaire (BCTQ) and electromyography (EMG) to assess symptom improvement, functional recovery, and median nerve regeneration.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Diagnosed with moderate-to-severe Carpal Tunnel Syndrome (CTS) based on electromyography (EMG) according to the Bland classification.
- •Persistent CTS symptoms that have not improved with conservative treatment.
- •Willing and able to provide written informed consent and comply with study procedures.
排除标准
- •Previous carpal tunnel release surgery on the affected wrist.
- •History of wrist trauma or previous wrist surgery.
- •Presence of comorbidities that may affect nerve healing or study outcomes, including diabetes mellitus, hypertension, or metabolic disorders.
- •Symptoms resembling CTS are attributable to other conditions, such as cervical spine or cervical nerve disorders (e.g., cervical radiculopathy).
结局指标
主要结局
Boston Carpal Tunnel Questionnaire (BCTQ) score
时间窗: Baseline and 3 weeks postoperatively
The Boston Carpal Tunnel Questionnaire (BCTQ), consisting of the Symptom Severity Scale (SSS) and Functional Status Scale (FSS), will be used to evaluate changes in symptom severity and hand function from baseline to 3 weeks after surgery.
Electromyography (EMG)
时间窗: Baseline and 3 weeks postoperatively
Electromyography (EMG) will be performed to assess changes in median nerve electrophysiological function, including nerve conduction parameters, from baseline to 3 weeks after surgery.
次要结局
未报告次要终点