Acupuncture Versus Laser Acupuncture for Carpal Tunnel Syndrome

Institutional Review Board of Kuang Tien General Hospital

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.

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Device: laser acupuncture; Other: acupuncture; Device: Sham laser acupuncture

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)

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LI-FENG LIN, Bachelor; Phone Number: 3109 +88642662-5111; Email: u100030053@cmu.edu.tw
• Study Contact Backup: Name: Chun-Pai Yang, PhD; Phone Number: 04-26885599; Email: neuralyung@gmail.com

Study Locations

• Taiwan
  • Taichung, Taiwan, 402
    • Recruiting
    • Kuang Tien Genreal Hospital
    • Contact: Li-Feng Lin; Phone Number: 0937165513

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

1. numbness, tingling pain, or paresthesia in the median nerve distribution
2. precipitation of these symptoms by repetitive hand activities, which could be relieved by resting, rubbing, and shaking the hand
3. nocturnal awakening by such sensory symptoms.
4. 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:

1. Symptoms occurring less than 3 months before the study (to exclude patients who might have spontaneous resolution of symptoms)
2. severe CTS that had progressed to visible muscle atrophy
3. 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
4. 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
5. cognitive impairment interfering with the subject's ability to follow instructions and describe symptoms

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser Acupuncture Group; 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)	Device: laser acupuncture; 400 mW, near-infrared, continuous wavelength, 810 nm. about 24J/cm2; Other Names: RJ-LASER, Germany
Active Comparator: Manual Acupuncture Group; 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	Other: acupuncture; Needle type: C&G, gauge and size: 0.25x40mm
Sham Comparator: Sham Laser Acupuncture Group; 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)	Device: Sham laser acupuncture; 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.; Other Names: RJ-LASER, Germany

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global symptom score	rated symptoms(Pain ,Numbness, paresthesia, Nocturnal awakening) from 0(no symptoms) to 10 (very severe symptoms)	Change from Baseline GSS at 2 weeks
Global symptom score	rated symptoms(Pain ,Numbness, paresthesia, Nocturnal awakening) from 0(no symptoms) to 10 (very severe symptoms)	Change from Baseline GSS at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nerve conduction studies	calculate the median nerve transduction speed	Change from Baseline nerve conduction studies (NCS) at 4 weeks

Collaborators and Investigators

• Sponsor: Kuang Tien General Hospital
• Investigators: Principal Investigator: Chun-Pai Yang, PhD, Kuang Tien Genreal Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Anticipated): May 20, 2022
• Study Completion (Anticipated): June 20, 2022

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: laser acupuncture; Carpal Tunnel Syndrome; manual acupuncture
• 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: KTGH10946

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No