NCT00952432Unknown不适用
A Single-center, Prospective, Randomized, Positive Controlled, Parallel Design Trial to Compare the Efficacy of Acupuncture Therapy and Carbamazepine Oral Dosage in Patients With Carpal Tunnel Syndrome by Multiple Excitability Test
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Use QtracW and NCS to evaluate the changes between pre-treatment and post-treatment in patients in both arms.
研究概览
简要总结
The goal of the study is to utilize BCTQ(Boston Carpal Tunnel Questionnaire), VAS (Visual Analog Scale), NCS (Nerve Conduction Study), and MET(Multiple Excitability Test) to evaluate and compare the efficacy of Acupuncture Therapy and Carbamazepine in Patients with Carpal 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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 20 years old
- •outpatient or inpatient subject with numbness of arm, clinically met diagnostic criteria of AAEM(American association of Electrodiagnostic Medicine CTS task force), and proven to have distal motor neurological disorder through nerve Conduction Study (distal motor latency >4.6 msec, decreased SNAP < 12uV or prolonged median sensory distal latency (palm to wrist) > 2.5msec)。
- •Willing to sign the Informed Consent form
排除标准
- •subject with external hand injury or disformation
- •subject with Polyneuritis or Cervical nerve root lesions
- •Subject with peripheral hypertrophy, hypothyroidism, multiple myeloma, or amyloidosis
- •Allergic to Carbamazepine or similar type of medicine
- •inability to act independently, or in the opinion of the investigator, not suitable for the study
- •In the opinion of the investigator, the subject requires surgical repair of the Carpal Tunnel Syndrome, or the symptoms will be worsen result in irreversible damage to the subject if not treated with surgical repair within 3 months.
研究组 & 干预措施
ACUPUNCTURE
Active Comparator
ACUPUNCTURE
干预措施: Acupuncture (Procedure)
MEDICATION
Active Comparator
Carbamazepine
干预措施: Carbamazepine (Drug)
结局指标
主要结局
Use QtracW and NCS to evaluate the changes between pre-treatment and post-treatment in patients in both arms.
时间窗: 12 weeks
次要结局
- use BCTQ to evaluate the efficacy of 2 arms at week 4 and at week 12.(12 weeks)
- use VAS to evaluate the efficacy of 2 arms at week 5, 8 and 12.(12 weeks)
- Use Quality of Life questionnaire to compare the efficacy of 2 arms at week 12.(12 weeks)
- Evaluate the safety of 2 arms during the study period(12 weeks)
研究者
研究点 (1)
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