The Evaluation for Fu's Subcutaneous Needling in Carpal Tunnel Syndrome: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of Boston Carpal Tunnel Questionnaire (BCTQ)
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of Fu's Subcutaneous Needling (FSN) in carpal tunnel syndrome (CTS). The main questions it aims to answer are:
- Dose FSN improve the symptoms of CTS?
- Dose FSN decrease cross section area of median nerve in CTS patients?
- Dose FSN have the effect of electrophysiology exam in CTS patients? Participants will receive wrist splinting and FSN treatment respectively. Researchers will compare wrist splinting group with FSN group to see if FSN being effective for CTS.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 20-85 years old.
- •Meet the diagnosis of mild to moderate carpal tunnel syndrome.
- •If the patient has carpal tunnel syndrome in both hands, choose the side with mild or moderate carpal tunnel syndrome.
- •After being explained, join the trial voluntarily and sign the subject's consent form.
排除标准
- •Caused by trauma or mass lesion.
- •Thenar muscle atrophy.
- •Electrophysiological examination revealed severe CTS.
- •Chronic kidney disease, rheumatoid arthritis, abnormal thyroid function, diabetes.
- •Psychiatric history or incapable of cooperating with the investigator.
- •History of substance abuse or long-term steroid use.
- •History of median nerve surgery.
- •Those who do not sign the consent form.
研究组 & 干预措施
wrist splinting group
wrist splinting at night for 2 weeks
干预措施: wrist splinting (Device)
FSN group
The needle inserted at the midpoint of the anterior forearm of the affected side. Swaying movement (SM) frequency is 200 times in 2 minutes. Reperfusion approach (RA) was performed with slow repetitively grasping movement while SM. On the 1st, 2nd, and 4th days, three times of FSN treatment were arranged.
干预措施: FSN (Device)
结局指标
主要结局
Change of Boston Carpal Tunnel Questionnaire (BCTQ)
时间窗: Change from baseline at one month after treatment.
BCTQ
Change of electrophysiology exam
时间窗: Change from baseline at one month after treatment.
Exam of motor latency
Change of cross section area of median nerve in ultrasound
时间窗: Change from baseline at one month after treatment
cross section area of median nerve
次要结局
未报告次要终点