Acupuncture Versus Laser Acupuncture for Carpal Tunnel Syndrome

Not Applicable

• Conditions: Carpal Tunnel Syndrome
• Interventions: Device: laser acupuncture; Device: Sham laser acupuncture; Other: acupuncture

• Registration Number: NCT04828239
• Lead Sponsor: Kuang Tien General Hospital

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)

Study Timeline

• Study Start: 2021-03-10
• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-02
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-11-30
• Primary Completion: 2022-05-20
• Study Completion: 2022-06-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser Acupuncture Group	laser acupuncture	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)
Sham Laser Acupuncture Group	Sham laser acupuncture	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)
Manual Acupuncture Group	acupuncture	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

Primary Outcome Measures

Name	Time	Method
Global symptom score	Change from Baseline GSS at 4 weeks	rated symptoms(Pain ,Numbness, paresthesia, Nocturnal awakening) from 0(no symptoms) to 10 (very severe symptoms)

Secondary Outcome Measures

Name	Time	Method
Nerve conduction studies	Change from Baseline nerve conduction studies (NCS) at 4 weeks	calculate the median nerve transduction speed

Trial Locations

Locations (1)

Kuang Tien Genreal Hospital; 🇨🇳 Taichung, Taiwan