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Efficacy of Laser Acupuncture for Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
laser phototherapy device with low level laser
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tri-Service General Hospital National Defense Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Six-sessions of laser acupuncture

Six-sessions of sham laser acupuncture

Arm Description

Laser acupuncture was given three times a week for 2 weeks.

Sham laser acupuncture was given three times a week for 2 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
June 25, 2018
Last Updated
April 8, 2019
Sponsor
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03580265
Brief Title
Efficacy of Laser Acupuncture for Carpal Tunnel Syndrome
Official Title
Efficacy of Laser Acupuncture for Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Six-sessions of laser acupuncture
Arm Type
Experimental
Arm Description
Laser acupuncture was given three times a week for 2 weeks.
Arm Title
Six-sessions of sham laser acupuncture
Arm Type
Sham Comparator
Arm Description
Sham laser acupuncture was given three times a week for 2 weeks.
Intervention Type
Device
Intervention Name(s)
laser phototherapy device with low level laser
Intervention Description
The wavelength of low level laser is 808nm and the power output of low level laser is 300mW.
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
baseline, 2th, 4th, 8th and 12th weeks after treatment
Secondary Outcome Measure Information:
Title
Change from baseline of pain on 2th, 4th, 8th and 12th weeks after treatment by using Visual analog scale (VAS).
Description
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.
Time Frame
baseline, 2th, 4th, 8th and 12th weeks after treatment
Title
Change from baseline of electrophysiological study and sonography on 2th, 4th, 8th and 12th weeks by using electrophysiological and sonographical machine measurement.
Description
Electrophysiological study and sonography according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA).
Time Frame
baseline, 2th, 4th, 8th and 12th weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chuan-Chih Chen, MD
Phone
+886-2-8792-3311
Ext
88203
Email
aoichih@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yung-Tsan Wu, MD
Phone
+886-2-8792-3311
Ext
17068
Email
crwu98@gmail.com
Facility Information:
Facility Name
Tri-Service General Hospital National Defense Medical Center
City
Taipei
State/Province
Neihu Dist.
ZIP/Postal Code
11490
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
12098159
Citation
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.
Results Reference
background
PubMed Identifier
20633458
Citation
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.
Results Reference
background
PubMed Identifier
24477392
Citation
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.
Results Reference
background
PubMed Identifier
28273894
Citation
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.
Results Reference
background
PubMed Identifier
31348263
Citation
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.
Results Reference
derived

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Efficacy of Laser Acupuncture for Carpal Tunnel Syndrome

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