Acupuncture Versus Laser Acupuncture for Carpal Tunnel Syndrome

NCT04828239 | Unknown DMC

• 1 other identifier: KTGH10946
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

laser acupuncture; Carpal Tunnel Syndrome; manual acupuncture

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Nerve conduction studies

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

Study Arms (3)

Laser Acupuncture Group

EXPERIMENTAL

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

Manual Acupuncture Group

ACTIVE COMPARATOR

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

Sham Laser Acupuncture Group

SHAM COMPARATOR

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

Interventions

laser acupuncture DEVICE

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

Also known as: RJ-LASER, Germany

Laser Acupuncture Group

acupuncture OTHER

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

Manual Acupuncture Group

Sham laser acupuncture 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.

Also known as: RJ-LASER, Germany

Sham Laser Acupuncture Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuang Tien General Hospital: lead

Study Sites (1)

Kuang Tien Genreal Hospital

Taichung, 402, Taiwan

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Chun-Pai Yang, PhD

  Kuang Tien Genreal Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LI-FENG LIN, Bachelor

CONTACT

+88642662-5111; u100030053@cmu.edu.tw

Chun-Pai Yang, PhD

CONTACT

04-26885599; neuralyung@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: TCM department

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

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 2, 2021
• Study Start: March 10, 2021
• Primary Completion: May 20, 2022
• Study Completion: June 20, 2022
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)