Efficacy of Laser Acupuncture for Carpal Tunnel Syndrome

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.

Study Overview

• Status: Unknown
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Device: laser phototherapy device with low level laser

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chuan-Chih Chen, MD; Phone Number: 88203 +886-2-8792-3311; Email: aoichih@hotmail.com

Study Locations

• Taiwan
  • Neihu Dist.
    • Taipei, Neihu Dist., Taiwan, 11490
      • Recruiting
      • Tri-Service General Hospital National Defense Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital

Publications and helpful links

General Publications

• Naeser MA, Hahn KA, Lieberman BE, Branco KF. Carpal tunnel syndrome pain treated with low-level laser and microamperes transcutaneous electric nerve stimulation: A controlled study. Arch Phys Med Rehabil. 2002 Jul;83(7):978-88. doi: 10.1053/apmr.2002.33096.
• Baxter GD, Bleakley C, McDonough S. Clinical effectiveness of laser acupuncture: a systematic review. J Acupunct Meridian Stud. 2008 Dec;1(2):65-82. doi: 10.1016/S2005-2901(09)60026-1.
• Fusakul Y, Aranyavalai T, Saensri P, Thiengwittayaporn S. Low-level laser therapy with a wrist splint to treat carpal tunnel syndrome: a double-blinded randomized controlled trial. Lasers Med Sci. 2014 May;29(3):1279-87. doi: 10.1007/s10103-014-1527-2. Epub 2014 Jan 30.
• Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Huang GS, Chen LC. Six-month efficacy of platelet-rich plasma for carpal tunnel syndrome: A prospective randomized, single-blind controlled trial. Sci Rep. 2017 Dec;7(1):94. doi: 10.1038/s41598-017-00224-6. Epub 2017 Mar 7.
• Chen CC, Wu YT, Su YC, Shen YP, Chen FP. Efficacy of laser acupuncture for carpal tunnel syndrome: A study protocol for a prospective double-blind randomized controlled trial. Medicine (Baltimore). 2019 Jul;98(30):e16516. doi: 10.1097/MD.0000000000016516.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ANTICIPATED): December 31, 2019
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: July 6, 2018
• First Posted (ACTUAL): July 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: TSGHIRB: 1-107-05-062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No