Acupuncture Versus Laser Acupuncture for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Institutional Review Board of Kuang Tien General Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04828239
• Other study ID #: KTGH10946
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: June 20, 2022

Study information

• Verified date: November 2021
• Source: Kuang Tien General Hospital
• Contact: LI-FENG LIN, Bachelor
• Phone: +88642662-5111
• Email: u100030053[@]cmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Device:
• laser acupuncture
400 mW, near-infrared, continuous wavelength, 810 nm. about 24J/cm2

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

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.

Locations

Country	Name	City	State
Taiwan	Kuang Tien Genreal Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Kuang Tien General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Nerve conduction studies	calculate the median nerve transduction speed	Change from Baseline nerve conduction studies (NCS) at 4 weeks