Efficacy of Laser Acupuncture for Carpal Tunnel Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Laser Acupuncture for Carpal Tunnel Syndrome

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Device: laser phototherapy device with low level laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Cancer 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Six-sessions of laser acupuncture<br>Laser acupuncture was given three times a week for 2 weeks. | Device: laser phototherapy device with low level laser<br>* The wavelength of low level laser is 808nm and the power output of low level laser is 300mW.<br>|
| Sham Comparator: Six-sessions of sham laser acupuncture<br>Sham laser acupuncture was given three times a week for 2 weeks. | Device: laser phototherapy device with low level laser<br>* The wavelength of low level laser is 808nm and the power output of low level laser is 300mW.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | baseline, 2th, 4th, 8th and 12th weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of pain on 2th, 4th, 8th and 12th weeks after treatment by using Visual analog scale (VAS). | The visual analog scale (VAS) is a measurement instrument that tries to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. Zero is the minimum score of pain and ten is the maximum score of pain. Using Visual analog scale (VAS) to measure the pain induced by carpal tunnel syndrome before treatment and multiple time frame after treatment. | 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. | Electrophysiological study and sonography according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA). | baseline, 2th, 4th, 8th and 12th weeks after treatment |