Institutional Review Board of Kuang Tien General Hospital
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Global symptom score
研究概览
简要总结
Carpal tunnel syndrome (CTS) results from the entrapment neuropathy of median nerve at the wrist, and most cases are idiopathic. So far, there are many treatments were developed (Surgical decompression, local injection of steroids, Wrist splints) but they are not fully satisfactory, other treatment modalities need to be further evaluated.
Both Acupuncture and laser acupuncture treatments for CTS have been reported. However, those studies still lack associated evidence to evaluate the efficacy of acupuncture and laser acupuncture.
The object of the study is to investigate the efficacy of acupuncture compared with laser acupuncture in patients with mild-to-moderate carpal tunnel syndrome (CTS). Nerve conduction studies (NCS) and global symptom score (GSS) assessment will apply to measure objective changes in this randomized, controlled study.
详细描述
Both manual acupuncture and laser acupuncture treatments for CTS have been reported.
Laser acupuncture (LA) is defined as the stimulation of traditional acupuncture points by using low-level intensity. Its a noninvasive treatment than acupuncture for those patients had the potential risk for infection or people involving pain or fear of needles. So far, previous studies still lack associated evidence about comparisons between laser acupuncture and manual acupuncture to evaluate their efficacy. So the investigators would like to compare the efficacy of acupuncture treatment with laser acupuncture (LA) treatment in patients with idiopathic, mild-to-moderate carpal tunnel syndrome (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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CTS diagnosis was based on the presence of at least one of the following symptoms
- •numbness, tingling pain, or paresthesia in the median nerve distribution
- •precipitation of these symptoms by repetitive hand activities, which could be relieved by resting, rubbing, and shaking the hand
- •nocturnal awakening by such sensory symptoms.
- •The diagnosis was often supported by a positive Tinel sign Confirmed by the presence of one or more of the following standard electrophysiologic criteria
- •(1) prolonged distal motor latency (DML) to the abductor pollicis brevis (APB) (abnormal Z4.7 ms, stimulation over the wrist, 8 cm proximal to the active electrode) (2) prolonged antidromic distal sensory latency (DSL) to the second digit (abnormal Z3.1 ms;stimulation over the wrist, 14 cm proximal to the active electrode) (3) prolonged antidromic wrist-palm sensory nerve conduction velocity (W-P SNCV) at a distance of 8 cm (W-P SNCV, abnormal <45 m/s).9-
排除标准
- •Symptoms occurring less than 3 months before the study (to exclude patients who might have spontaneous resolution of symptoms)
- •severe CTS that had progressed to visible muscle atrophy
- •clinical or electrophysiologic evidence of accompanying conditions that could mimic CTS or interfere with its evaluation, such as cervical radiculopathy, proximal median neuropathy, or significant polyneuropathy
- •evidence of obvious underlying etiologic factors of CTS such as diabetes mellitus, rheumatoid arthritis, hypothyroidism (acromegaly), pregnancy, alcohol abuse or drug usage (steroids or drugs acting through the central nervous system), and suspected malignancy or inflammation or autoimmune disease documented as underlying causes of CTS
- •cognitive impairment interfering with the subject's ability to follow instructions and describe symptoms
结局指标
主要结局
Global symptom score
时间窗: Change from Baseline GSS at 4 weeks
rated symptoms(Pain ,Numbness, paresthesia, Nocturnal awakening) from 0(no symptoms) to 10 (very severe symptoms)
次要结局
- Nerve conduction studies(Change from Baseline nerve conduction studies (NCS) at 4 weeks)
研究者
Li-Feng Lin
TCM department
Kuang Tien General Hospital