Acupuncture Versus Laser Acupuncture for Carpal Tunnel Syndrome

NCT ID: NCT04828239

Last Updated: 2021-11-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-10
• Study Completion Date: 2022-06-20

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)

Conditions

Carpal Tunnel Syndrome

Keywords

laser acupuncture; Carpal Tunnel Syndrome; manual acupuncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

laser acupuncture

Intervention Type: DEVICE

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

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

Group Type: ACTIVE_COMPARATOR

acupuncture

Intervention Type: OTHER

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

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)

Group Type: SHAM_COMPARATOR

Sham laser acupuncture

Intervention Type: DEVICE

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.

Interventions

laser acupuncture

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

Intervention Type: DEVICE

acupuncture

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

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Other Intervention Names

RJ-LASER, Germany; RJ-LASER, Germany

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kuang Tien General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Li-Feng Lin

TCM department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chun-Pai Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

Kuang Tien Genreal Hospital

Locations

Kuang Tien Genreal Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

LI-FENG LIN, Bachelor

Role: CONTACT

Phone: +88642662-5111

Email: u100030053@cmu.edu.tw

Chun-Pai Yang, PhD

Role: CONTACT

Phone: 04-26885599

Email: neuralyung@gmail.com

Facility Contacts

Li-Feng Lin

Role: primary

Other Identifiers

KTGH10946

Identifier Type: -

Identifier Source: org_study_id