Efficacy of Laser Acupuncture for Carpal Tunnel Syndrome
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2018
CompletedFirst Posted
Study publicly available on registry
July 9, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedApril 10, 2019
April 1, 2019
12 months
June 25, 2018
April 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (2)
Six-sessions of laser acupuncture
EXPERIMENTALLaser acupuncture was given three times a week for 2 weeks.
Six-sessions of sham laser acupuncture
SHAM COMPARATORSham laser acupuncture was given three times a week for 2 weeks.
Interventions
The wavelength of low level laser is 808nm and the power output of low level laser is 300mW.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tri-Service General Hospital National Defense Medical Center
Taipei, Neihu Dist., 11490, Taiwan
Related Publications (5)
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.
PMID: 12098159BACKGROUNDBaxter 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.
PMID: 20633458BACKGROUNDFusakul 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.
PMID: 24477392BACKGROUNDWu 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.
PMID: 28273894BACKGROUNDChen 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.
PMID: 31348263DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician of Department of Chinese Medicine
Study Record Dates
First Submitted
June 25, 2018
First Posted
July 9, 2018
Study Start
January 1, 2019
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
April 10, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will share