Efficacy of Laser Acupuncture for Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from baseline of severity of symptoms and functional status on 2th, 4th, 8th and 12th weeks after treatment by using Boston Carpal Tunnel Questionnaire (BCTQ).
研究概览
简要总结
The laser acupuncture is a new and potential intervention for the disease of peripheral nerve. The purpose of this study was to assess the effect of laser acupucnture therapy on carpal tunnel syndrome.
详细描述
Laser acupuncture is combined low level laser with acupuncture points. Investigators perform a prospective randomized, single-blinded study to investigate the efficacy of laser acupuncture in patients with carpal tunnel syndrome. Patients were randomized into intervention and control group. Participants in intervention group received six-sessions of laser acupuncture and six-sessions of sham laser acupuncture was given in control group. All participants used wrist splint at night. The evaluation was performed pretreatment as well as on the 2th, 4th, 8th and 12th week after the treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20-80 year-old.
- •Typical symptoms and signs of mild to moderate carpal tunnel syndrome, such as positive Tinel's sign numbness/tingling in at least 5th digits, and in whom the diagnosis was confirmed using an electrophysiological study.
排除标准
- •Coagulopathy
- •Pregnancy
- •Inflammation status
- •Patients who had conditions mimicking carpal tunnel syndrome, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for carpal tunnel syndrome.
- •There are tattoos, birthmarks and skin disorders over acupuncture points.
研究组 & 干预措施
Six-sessions of laser acupuncture
Laser acupuncture was given three times a week for 2 weeks.
干预措施: laser phototherapy device with low level laser (Device)
Six-sessions of sham laser acupuncture
Sham laser acupuncture was given three times a week for 2 weeks.
干预措施: laser phototherapy device with low level laser (Device)
结局指标
主要结局
Change from baseline of severity of symptoms and functional status on 2th, 4th, 8th and 12th weeks after treatment by using Boston Carpal Tunnel Questionnaire (BCTQ).
时间窗: baseline, 2th, 4th, 8th and 12th weeks after treatment
The Boston Carpal Tunnel Questionnaire (BCTQ) is a disease-specific measure of self-reported symptom severity and functional status. One is the minimum score and five is the maximum score in each symptom severity scale (11 items). The total score range of symptom severity scale is 11 to 55. One is the minimum score and five is the maximum score in each functional status scale (8 items). The total score range of functional status scale is 8 to 40. Using the Boston Carpal Tunnel Questionnaire to measure the symptoms and functional status of carpal tunnel syndrome before treatment and multiple time frame after treatment.
次要结局
- Change from baseline of pain on 2th, 4th, 8th and 12th weeks after treatment by using Visual analog scale (VAS).(baseline, 2th, 4th, 8th and 12th weeks after treatment)
- Change from baseline of electrophysiological study and sonography on 2th, 4th, 8th and 12th weeks by using electrophysiological and sonographical machine measurement.(baseline, 2th, 4th, 8th and 12th weeks after treatment)
研究者
Chuan-Chih Chen
Attending Physician of Department of Chinese Medicine
Tri-Service General Hospital