Brief Electrical Stimulation for Promoting Peripheral Nerve Regeneration After Primary Neurorrhaphy of Upper Extremities
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- NCV/EMG(CMAP,latency)
研究概览
简要总结
During the process of nerve microsurgical reconstruction, 30 minutes of electrical stimulation is applied to the distal end of the damaged nerve to assess its potential benefits for nerve regeneration, functional recovery, slowing down the degeneration at the neuromuscular junction, and preventing muscle atrophy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 and older
- •Acute peripheral nerve rupture between the elbow and wrist
- •Acute rupture of the median or ulnar nerve
- •Patients who have signed a valid written consent for surgery and trials
- •Patients with acute transection or compression of the median nerve or ulnar nerve resulting in impaired hand motor function.Patients with hand motor dysfunction secondary to nerve compression are defined as those who meet all of the following criteria:
- •Evidence of muscle atrophy (including thenar muscles, hypothenar muscles, and interosseous muscles)
- •Positive Froment's sign
- •Positive Wartenberg's sign
- •Presence of ape hand deformity
- •Abnormal findings on electromyography (Needle EMG), such as abnormal insertional activity, increased spontaneous activity, or abnormal motor unit recruitment
- •Classified as Grade IIA, IIB, or III according to the McGowan classification system for severity of nerve compression
排除标准
- •History of injury or other causes leading to muscle and joint dysfunction in the affected area
- •Patients with radial nerve damage
- •History of arrhythmia
- •Multiple sclerosis
- •Hereditary peripheral neuropathy
- •Amyotrophic lateral sclerosis (ALS)
- •Patients with a pacemaker
- •Presence of local infection at the wound site
- •Pregnant or breastfeeding women
- •Patients deemed unsuitable for enrollment by a physician
研究组 & 干预措施
nerve electrical stimulation
During the process of nerve microsurgical reconstruction, a 30-minute electric stimulation is applied to the distal end of the damaged nerve.
干预措施: Brief electrical stimulation (Other)
nerve microsurgical reconstruction
no nerve electrical stimulation
干预措施: no nerve electrical stimulation (Other)
结局指标
主要结局
NCV/EMG(CMAP,latency)
时间窗: The third month after surgery.
The electromyography (EMG) is a diagnostic method used to assess muscle and nerve function, primarily to detect muscle activity and nerve conduction velocity, in order to monitor the recovery of neuromuscular function after surgery. During the EMG examination, the examiner uses electrodes attached to the palm to measure and record the electrophysiological signals of the muscles for further analysis. Through this method, doctors can evaluate the electrophysiological activity of the muscles to assess the reinnervation of distal muscles by the damaged nerves.
次要结局
- DASH questionnaire(The first, third, and sixth months after surgery.)
- Muscle power(The third and sixth months after surgery.)
- Purdue Pegboard test(The third and sixth months after surgery.)
- MMDT(The third and sixth months after surgery)
- NCV/EMG(CMAP,latency)(The sixth month after surgery.)
- DASH questionnaire(Preoperative (applicable to subjects with nerve compression), the first, third, and sixth months after surgery.)
- Muscle power(Preoperative (applicable to subjects with nerve compression), the third and sixth months after surgery.)
- Purdue Pegboard test(Preoperative (applicable to subjects with nerve compression), the third and sixth months after surgery.)
- MMDT(Preoperative (applicable to subjects with nerve compression), the third and sixth months after surgery)
- NCV/EMG(CMAP,latency)(Preoperative (applicable to subjects with nerve compression) and the sixth month after surgery.)