Efficacy of Laser Acupuncture for Carpal Tunnel Syndrome

NCT ID: NCT03580265

Last Updated: 2019-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-12-31

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.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Six-sessions of laser acupuncture

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

Group Type EXPERIMENTAL

laser phototherapy device with low level laser

Intervention Type DEVICE

The wavelength of low level laser is 808nm and the power output of low level laser is 300mW.

Six-sessions of sham laser acupuncture

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

Group Type SHAM_COMPARATOR

laser phototherapy device with low level laser

Intervention Type DEVICE

The wavelength of low level laser is 808nm and the power output of low level laser is 300mW.

Interventions

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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.

Intervention Type DEVICE

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chuan-Chih Chen

Attending Physician of Department of Chinese Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tri-Service General Hospital National Defense Medical Center

Taipei, Neihu Dist., Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chuan-Chih Chen, MD

Role: CONTACT

+886-2-8792-3311 ext. 88203

Yung-Tsan Wu, MD

Role: CONTACT

+886-2-8792-3311 ext. 17068

References

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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.

Reference Type BACKGROUND
PMID: 12098159 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20633458 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24477392 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28273894 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31348263 (View on PubMed)

Other Identifiers

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TSGHIRB: 1-107-05-062

Identifier Type: -

Identifier Source: org_study_id

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