Compare the Efficacy of Acupuncture Therapy and Carbamazepine Oral Dosage in Patients With Carpal Tunnel Syndrome by Multiple Excitability Test

Sponsor

Taipei Medical University WanFang Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00952432

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of the study is to utilize BCTQ(Boston Carpal Tunnel Questionnaire), VAS (Visual Analog Scale), NCS (Nerve Conduction Study), and MET(Multiple Excitability Test) to evaluate and compare the efficacy of Acupuncture Therapy and Carbamazepine in Patients with Carpal Tunnel Syndrome.

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome Multiple Excitability Test	Drug: Carbamazepine Procedure: Acupuncture	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Single-center, Prospective, Randomized, Positive Controlled, Parallel Design Trial to Compare the Efficacy of Acupuncture Therapy and Carbamazepine Oral Dosage in Patients With Carpal Tunnel Syndrome by Multiple Excitability Test

Study Start Date :

May 1, 2009

Anticipated Primary Completion Date :

May 1, 2011

Anticipated Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ACUPUNCTURE ACUPUNCTURE	Procedure: Acupuncture Acupuncture
Active Comparator: MEDICATION Carbamazepine	Drug: Carbamazepine Carbamazepine 200mg, 1/2 tablet, TID for 1 month

Arm

Intervention/Treatment

Active Comparator: ACUPUNCTURE

ACUPUNCTURE

Procedure: Acupuncture

Acupuncture

Active Comparator: MEDICATION

Carbamazepine

Drug: Carbamazepine

Carbamazepine 200mg, 1/2 tablet, TID for 1 month

Outcome Measures

Primary Outcome Measures

Use QtracW and NCS to evaluate the changes between pre-treatment and post-treatment in patients in both arms. [12 weeks]

Secondary Outcome Measures

use BCTQ to evaluate the efficacy of 2 arms at week 4 and at week 12. [12 weeks]
use VAS to evaluate the efficacy of 2 arms at week 5, 8 and 12. [12 weeks]
Use Quality of Life questionnaire to compare the efficacy of 2 arms at week 12. [12 weeks]
Evaluate the safety of 2 arms during the study period [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age greater than 20 years old
outpatient or inpatient subject with numbness of arm, clinically met diagnostic criteria of AAEM(American association of Electrodiagnostic Medicine CTS task force), and proven to have distal motor neurological disorder through nerve Conduction Study (distal motor latency >4.6 msec, decreased SNAP < 12uV or prolonged median sensory distal latency (palm to wrist) > 2.5msec)。
Willing to sign the Informed Consent form

Exclusion Criteria:

subject with external hand injury or disformation
subject with Polyneuritis or Cervical nerve root lesions
Subject with peripheral hypertrophy, hypothyroidism, multiple myeloma, or amyloidosis
Allergic to Carbamazepine or similar type of medicine
inability to act independently, or in the opinion of the investigator, not suitable for the study
In the opinion of the investigator, the subject requires surgical repair of the Carpal Tunnel Syndrome, or the symptoms will be worsen result in irreversible damage to the subject if not treated with surgical repair within 3 months.