The Effect of Acupuncture and Laser Acupuncture for Carpal Tunnel Syndrome

January 10, 2024 updated by: Chang Gung Memorial Hospital

The Effect of Acupuncture and Laser Acupuncture for Carpal Tunnel Syndrome-A 3-arm, Randomized Sham Laser Acupuncture Controlled Study

Acupuncture and laser acupuncture treatments have been proven to be effective and safe treatments for carpal tunnel syndrome(CTS). However, there is still a lack of direct comparative studies of acupuncture and laser acupuncture in the treatment of CTS. A 3-arm, randomized controlled study in acupuncture, laser acupuncture study and sham laser acupuncture therapy was designed for patient with carpal tunnel syndrome. The Glabal symptom score (GSS), Boston Carpal Tunnel Questionnaire (BCTQ), neurophysiological study, morphological examination under ultrasonography will be evaluated before and after treatment. Comparison of therapeutic efficacy of acupuncture, laser acupuncture and sham laser acupuncture in the treatment of CTS will be explored.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The primary outcome will analyze the change of the Glabal symptom score (GSS) during intervention peroid. The secondary outcome will evaluate the neurophysiological study, morphological examination under ultrasonography before and after treatment. Comparison of therapeutic efficacy of acupuncture, laser acupuncture and sham laser acupuncture in the treatment of CTS will be explored.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with mild to moderate carpal tunnel syndrome diagnosed by neurophysiological examination
  • symptoms of carpal tunnel syndrome such as pain and numbness
  • those who are willing to sign informed consent form for subjects

Exclusion Criteria:

  • (1) Those who have not signed the informed consent
  • (2) Patients diagnosed with severe carpal tunnel syndrome
  • (3) Those who have had a history of surgery on their hands and palms
  • (4) Space-occupying lesions such as tumors, bone spurs, synovial membrane tissue hypertrophy, etc.
  • (5) People with a history of diabetes, rheumatoid arthritis, and hypothyroidism (HbA1c>6.5, RF positive, Free T4, TSH in abnormal range)
  • (6) Patients with end-stage renal disease
  • (7) Pregnant and alcoholic patients
  • (8) Polyneuropathy patients
  • (9) Clinical symptoms with C6~8 cervical radiculopathy
  • (10) Those who are obviously infected
  • (11) Those with a serious illness requiring hospitalization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MA group (manual acupuncture group)
Acupunctue Needle: 1 inch- 32 gauge（0.3x25 mm）for 20 min after De-qi Acupoints selection: PC4[Ximen], PC6[Neiguan], PC7[Daling], PC8[Laogong], HT2[Qingling], HT7[Shenmen], HT8[Shaofu], LU9[Taiyuan], LI11[Quchi]
Procedure: manual acupuncture
manual acupuncture
Device: wrist splint
wear wrist splint at night
Experimental: LA group (laser acupuncture group)
laser acupuncture gruoup with LaserPen, 150 mW; wavelength, 810nm; area of probe, 0.03cm2; power density, 5W/cm2; pulsed wave; Nogier C frequency for 4 J each points The acupoints selection is the same as the MA group.
Device: wrist splint
wear wrist splint at night
Device: laser acupuncture
laser acupuncture therapy
Sham Comparator: SLA group (sham laser acupuncture group)
sham laser acupuncture group is designed with the same acupoints selection and no energy output
Device: wrist splint
wear wrist splint at night
Device: sham laser acupuncture
sham laser acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Boston Carpal Tunnel Questionnaire(BCTQ) changes
Time Frame: from baseline to 3 months
The Boston Carpal Tunnel Questionnaire(BCTQ) is a questionnaire for CTS patients, which has been used widely in the world. It contains two parts. One part is the symptom severity scale (BCTQsss) which contains eleven questions about symptom severity, and another part is the function severity scale (BCTQfss) contains eight questions about functional status evaluation. Each selection option includes 1~5 to present different degrees of severity ("5" is the most severe). The max of BCTQsss is 55 and the min is 11. The max of BCTQfss is 40 and the min is 8. The higher scores mean a worse outcome.
from baseline to 3 months
Global symptoms score(GSS) changes
Time Frame: from baseline to 3 months

GSS is a questionnaire to evaluate the severity of five symptoms, including pain, numbness, paresthesias, weakness/ clumsy, and nocturnal awakening for CTS patients.

The score of pain, numbness, and paresthesias according to the magnitude: from 0 (nil) to 10 (most severe).

The score for weakness/ clumsiness is according to the severity: 0 (none); 2(mild); 3(moderate); 4(severe); 5(very severe).

The score for nocturnal awakening is according to how many times awaked in one week: 0(never); 2(once or twice); 4(three or four times); 6(five to seven times); 8(eight to ten times); 10(more than ten times).

The total score added up forms the GSS score. The minimum score is 0, and the maximum score is 50. The higher scores mean a worse outcome.
from baseline to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compound motor action potential(CMAP)
Time Frame: from baseline to 3 months

Nerve Electrophysiological examination of median nerve.The neurophysiological study of the median nerve will be recorded and compared before and after 15 sessions of treatments including compound motor action potential(CMAP).

The unit of CMAP is millivolt (mV).
from baseline to 3 months
motor distal latency(MDL)
Time Frame: from baseline to 3 months

Nerve Electrophysiological examination of median nerve. The neurophysiological study of the median nerve will be recorded and compared before and after 15 sessions of treatments including motor distal latency(MDL).

The unit of motor distal latency is millisecond (ms).
from baseline to 3 months
Sensory nerve action potential (SNAP)
Time Frame: from baseline to 3 months

Nerve Electrophysiological examination of median nerve. The neurophysiological study of the median nerve will be recorded and compared before and after 15 sessions of treatments including Sensory nerve action potential (SNAP).

The unit of SNAP is also millivolt (mV).
from baseline to 3 months
sensory distal latency(SDL)
Time Frame: from baseline to 3 months

Nerve Electrophysiological examination of median nerve. The neurophysiological study of the median nerve will be recorded and compared before and after 15 sessions of treatments including sensory distal latency(SDL).

The unit of sensory distal latency is also millisecond (ms).
from baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Huang, Chang Gung memorial hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

August 17, 2021

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Estimated)

January 11, 2024

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201901768A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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