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

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”

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.

Intervention(s) in this Clinical Trial

• Drug: Carbamazepine
  • Carbamazepine 200mg, 1/2 tablet, TID for 1 month
• Procedure: Acupuncture
  • Acupuncture

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: ACUPUNCTURE
  • ACUPUNCTURE
• Active Comparator: MEDICATION
  • Carbamazepine

Primary Measures

• Use QtracW and NCS to evaluate the changes between pre-treatment and post-treatment in patients in both arms.
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• use BCTQ to evaluate the efficacy of 2 arms at week 4 and at week 12.
  • Time Frame: 12 weeks
    Safety Issue?: No
• use VAS to evaluate the efficacy of 2 arms at week 5, 8 and 12.
  • Time Frame: 12 weeks
    Safety Issue?: No
• Use Quality of Life questionnaire to compare the efficacy of 2 arms at week 12.
  • Time Frame: 12 weeks
    Safety Issue?: No
• Evaluate the safety of 2 arms during the study period
  • Time Frame: 12 weeks
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Taipei Medical University WanFang Hospital Other

Overall Clinical Trial Officials and Contacts

Jia-Ying Sung, MD Principal Investigator Taipei Medical University-Wan Fang Hospital  

Overall Contact: Jia-Ying Sung, MD +886-2-2930-7930 96317@wanfang.gov.tw

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00952432

Study ID Number: 2008WFCRC-07

ClinicalTrials.gov Identifier: NCT00952432

Health Authority: Taiwan: Department of Health