The Effect of Acupuncture and Laser Acupuncture for Carpal Tunnel Syndrome-A 3-arm, Randomized Sham Laser Acupuncture Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The Boston Carpal Tunnel Questionnaire(BCTQ) changes
研究概览
简要总结
Acupuncture and laser acupuncture treatments have been proven to be effective and safe treatments for carpal tunnel syndrome(CTS). However, there is still a lack of direct comparative studies of acupuncture and laser acupuncture in the treatment of CTS. A 3-arm, randomized controlled study in acupuncture, laser acupuncture study and sham laser acupuncture therapy was designed for patient with carpal tunnel syndrome. The Glabal symptom score (GSS), Boston Carpal Tunnel Questionnaire (BCTQ), neurophysiological study, morphological examination under ultrasonography will be evaluated before and after treatment. Comparison of therapeutic efficacy of acupuncture, laser acupuncture and sham laser acupuncture in the treatment of CTS will be explored.
详细描述
The primary outcome will analyze the change of the Glabal symptom score (GSS) during intervention peroid. The secondary outcome will evaluate the neurophysiological study, morphological examination under ultrasonography before and after treatment. Comparison of therapeutic efficacy of acupuncture, laser acupuncture and sham laser acupuncture in the treatment of CTS will be explored.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with mild to moderate carpal tunnel syndrome diagnosed by neurophysiological examination
- •symptoms of carpal tunnel syndrome such as pain and numbness
- •those who are willing to sign informed consent form for subjects
排除标准
- •(1) Those who have not signed the informed consent
- •(2) Patients diagnosed with severe carpal tunnel syndrome
- •(3) Those who have had a history of surgery on their hands and palms
- •(4) Space-occupying lesions such as tumors, bone spurs, synovial membrane tissue hypertrophy, etc.
- •(5) People with a history of diabetes, rheumatoid arthritis, and hypothyroidism (HbA1c>6.5, RF positive, Free T4, TSH in abnormal range)
- •(6) Patients with end-stage renal disease
- •(7) Pregnant and alcoholic patients
- •(8) Polyneuropathy patients
- •(9) Clinical symptoms with C6~8 cervical radiculopathy
- •(10) Those who are obviously infected
- •(11) Those with a serious illness requiring hospitalization
结局指标
主要结局
The Boston Carpal Tunnel Questionnaire(BCTQ) changes
时间窗: from baseline to 3 months
The Boston Carpal Tunnel Questionnaire(BCTQ) is a questionnaire for CTS patients, which has been used widely in the world. It contains two parts. One part is the symptom severity scale (BCTQsss) which contains eleven questions about symptom severity, and another part is the function severity scale (BCTQfss) contains eight questions about functional status evaluation. Each selection option includes 1\~5 to present different degrees of severity ("5" is the most severe). The max of BCTQsss is 55 and the min is 11. The max of BCTQfss is 40 and the min is 8. The higher scores mean a worse outcome.
Global symptoms score(GSS) changes
时间窗: from baseline to 3 months
GSS is a questionnaire to evaluate the severity of five symptoms, including pain, numbness, paresthesias, weakness/ clumsy, and nocturnal awakening for CTS patients. The score of pain, numbness, and paresthesias according to the magnitude: from 0 (nil) to 10 (most severe). The score for weakness/ clumsiness is according to the severity: 0 (none); 2(mild); 3(moderate); 4(severe); 5(very severe). The score for nocturnal awakening is according to how many times awaked in one week: 0(never); 2(once or twice); 4(three or four times); 6(five to seven times); 8(eight to ten times); 10(more than ten times). The total score added up forms the GSS score. The minimum score is 0, and the maximum score is 50. The higher scores mean a worse outcome.
次要结局
- Sensory nerve action potential (SNAP)(from baseline to 3 months)
- compound motor action potential(CMAP)(from baseline to 3 months)
- sensory distal latency(SDL)(from baseline to 3 months)
- motor distal latency(MDL)(from baseline to 3 months)