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Acupuncture Versus Laser Acupuncture for Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

laser acupuncture

acupuncture

Sham laser acupuncture

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring laser acupuncture, Carpal Tunnel Syndrome, manual acupuncture

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

CTS diagnosis was based on the presence of at least one of the following symptoms

numbness, tingling pain, or paresthesia in the median nerve distribution
precipitation of these symptoms by repetitive hand activities, which could be relieved by resting, rubbing, and shaking the hand
nocturnal awakening by such sensory symptoms.
The diagnosis was often supported by a positive Tinel sign Confirmed by the presence of one or more of the following standard electrophysiologic criteria

(1) prolonged distal motor latency (DML) to the abductor pollicis brevis (APB) (abnormal Z4.7 ms, stimulation over the wrist, 8 cm proximal to the active electrode) (2) prolonged antidromic distal sensory latency (DSL) to the second digit (abnormal Z3.1 ms;stimulation over the wrist, 14 cm proximal to the active electrode) (3) prolonged antidromic wrist-palm sensory nerve conduction velocity (W-P SNCV) at a distance of 8 cm (W-P SNCV, abnormal <45 m/s).9-

Exclusion Criteria:

Symptoms occurring less than 3 months before the study (to exclude patients who might have spontaneous resolution of symptoms)
severe CTS that had progressed to visible muscle atrophy
clinical or electrophysiologic evidence of accompanying conditions that could mimic CTS or interfere with its evaluation, such as cervical radiculopathy, proximal median neuropathy, or significant polyneuropathy
evidence of obvious underlying etiologic factors of CTS such as diabetes mellitus, rheumatoid arthritis, hypothyroidism (acromegaly), pregnancy, alcohol abuse or drug usage (steroids or drugs acting through the central nervous system), and suspected malignancy or inflammation or autoimmune disease documented as underlying causes of CTS
cognitive impairment interfering with the subject's ability to follow instructions and describe symptoms

Sites / Locations

Kuang Tien Genreal HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Laser Acupuncture Group

Manual Acupuncture Group

Sham Laser Acupuncture Group

Arm Description

Acupuncture point: PC-6 and PC-7 laser pen is vertical to the points and with the pen at a distance of 0.5- cm from the skin., every point is treated for 1 min administrated over 4 weeks (2 sessions/wk)

Acupuncture point: PC-6 and PC-7 Responses elicited: de qi sensation Manual: twirling with lifting-thrusting method stimulation Needles retained for 30 min Needle type: C&G, gauge and size: 0.25x40mm

Acupuncture point: PC-6 and PC-7 Sham laser pen is vertical to the points and with the pen at a distance of 0.5- cm from the skin., every point is treated for 1 min administrated over 4 weeks (2 sessions/wk)

Outcomes

Primary Outcome Measures

Global symptom score

rated symptoms(Pain ,Numbness, paresthesia, Nocturnal awakening) from 0(no symptoms) to 10 (very severe symptoms)

Global symptom score

rated symptoms(Pain ,Numbness, paresthesia, Nocturnal awakening) from 0(no symptoms) to 10 (very severe symptoms)

Secondary Outcome Measures

Nerve conduction studies

calculate the median nerve transduction speed

Full Information

NCT ID

NCT04828239

First Posted

March 24, 2021

Last Updated

November 29, 2021

Sponsor

Kuang Tien General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04828239

Brief Title

Acupuncture Versus Laser Acupuncture for Carpal Tunnel Syndrome

Official Title

Institutional Review Board of Kuang Tien General Hospital

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

March 10, 2021 (Actual)

Primary Completion Date

May 20, 2022 (Anticipated)

Study Completion Date

June 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kuang Tien General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Carpal tunnel syndrome (CTS) results from the entrapment neuropathy of median nerve at the wrist, and most cases are idiopathic. So far, there are many treatments were developed (Surgical decompression, local injection of steroids, Wrist splints) but they are not fully satisfactory, other treatment modalities need to be further evaluated. Both Acupuncture and laser acupuncture treatments for CTS have been reported. However, those studies still lack associated evidence to evaluate the efficacy of acupuncture and laser acupuncture. The object of the study is to investigate the efficacy of acupuncture compared with laser acupuncture in patients with mild-to-moderate carpal tunnel syndrome (CTS). Nerve conduction studies (NCS) and global symptom score (GSS) assessment will apply to measure objective changes in this randomized, controlled study.

Detailed Description

Both manual acupuncture and laser acupuncture treatments for CTS have been reported. Laser acupuncture (LA) is defined as the stimulation of traditional acupuncture points by using low-level intensity. Its a noninvasive treatment than acupuncture for those patients had the potential risk for infection or people involving pain or fear of needles. So far, previous studies still lack associated evidence about comparisons between laser acupuncture and manual acupuncture to evaluate their efficacy. So the investigators would like to compare the efficacy of acupuncture treatment with laser acupuncture (LA) treatment in patients with idiopathic, mild-to-moderate carpal tunnel syndrome (CTS)

6. Conditions and Keywords

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

Carpal Tunnel Syndrome

Keywords

laser acupuncture, Carpal Tunnel Syndrome, manual acupuncture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The recruited patients were randomly divided into two groups of ''Laser Acupuncture Group'' and ''Manual Acupuncture Group"

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Laser Acupuncture Group

Arm Type

Experimental

Arm Description

Arm Title

Manual Acupuncture Group

Arm Type

Active Comparator

Arm Description

Acupuncture point: PC-6 and PC-7 Responses elicited: de qi sensation Manual: twirling with lifting-thrusting method stimulation Needles retained for 30 min Needle type: C&G, gauge and size: 0.25x40mm

Arm Title

Sham Laser Acupuncture Group

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

laser acupuncture

Other Intervention Name(s)

RJ-LASER, Germany

Intervention Description

400 mW, near-infrared, continuous wavelength, 810 nm. about 24J/cm2

Intervention Type

Other

Intervention Name(s)

acupuncture

Intervention Description

Needle type: C&G, gauge and size: 0.25x40mm

Intervention Type

Device

Intervention Name(s)

Sham laser acupuncture

Other Intervention Name(s)

RJ-LASER, Germany

Intervention Description

This laser pen is the same device with a red light was pasted on the acu-points in the same way, using the same protocol as for the active laser stimulation, but the laser apparatus was not switched on.

Primary Outcome Measure Information:

Title

Global symptom score

Description

rated symptoms(Pain ,Numbness, paresthesia, Nocturnal awakening) from 0(no symptoms) to 10 (very severe symptoms)

Time Frame

Change from Baseline GSS at 2 weeks

Title

Global symptom score

Description

rated symptoms(Pain ,Numbness, paresthesia, Nocturnal awakening) from 0(no symptoms) to 10 (very severe symptoms)

Time Frame

Change from Baseline GSS at 4 weeks

Secondary Outcome Measure Information:

Title

Nerve conduction studies

Description

calculate the median nerve transduction speed

Time Frame

Change from Baseline nerve conduction studies (NCS) at 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: CTS diagnosis was based on the presence of at least one of the following symptoms numbness, tingling pain, or paresthesia in the median nerve distribution precipitation of these symptoms by repetitive hand activities, which could be relieved by resting, rubbing, and shaking the hand nocturnal awakening by such sensory symptoms. The diagnosis was often supported by a positive Tinel sign Confirmed by the presence of one or more of the following standard electrophysiologic criteria (1) prolonged distal motor latency (DML) to the abductor pollicis brevis (APB) (abnormal Z4.7 ms, stimulation over the wrist, 8 cm proximal to the active electrode) (2) prolonged antidromic distal sensory latency (DSL) to the second digit (abnormal Z3.1 ms;stimulation over the wrist, 14 cm proximal to the active electrode) (3) prolonged antidromic wrist-palm sensory nerve conduction velocity (W-P SNCV) at a distance of 8 cm (W-P SNCV, abnormal <45 m/s).9- Exclusion Criteria: Symptoms occurring less than 3 months before the study (to exclude patients who might have spontaneous resolution of symptoms) severe CTS that had progressed to visible muscle atrophy clinical or electrophysiologic evidence of accompanying conditions that could mimic CTS or interfere with its evaluation, such as cervical radiculopathy, proximal median neuropathy, or significant polyneuropathy evidence of obvious underlying etiologic factors of CTS such as diabetes mellitus, rheumatoid arthritis, hypothyroidism (acromegaly), pregnancy, alcohol abuse or drug usage (steroids or drugs acting through the central nervous system), and suspected malignancy or inflammation or autoimmune disease documented as underlying causes of CTS cognitive impairment interfering with the subject's ability to follow instructions and describe symptoms

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

LI-FENG LIN, Bachelor

Phone

+88642662-5111

Ext

3109

u100030053@cmu.edu.tw

First Name & Middle Initial & Last Name or Official Title & Degree

Chun-Pai Yang, PhD

Phone

04-26885599

neuralyung@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chun-Pai Yang, PhD

Organizational Affiliation

Kuang Tien Genreal Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kuang Tien Genreal Hospital

City

Taichung

ZIP/Postal Code

402

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Li-Feng Lin

Phone

0937165513

12. IPD Sharing Statement

Plan to Share IPD

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Acupuncture Versus Laser Acupuncture for Carpal Tunnel Syndrome

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