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

Carpal Tunnel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00952432
• Other study ID #: 2008WFCRC-07
• Status: Recruiting
• Phase: N/A
• First received: August 3, 2009
• Last updated: April 11, 2011
• Start date: May 2009
• Est. completion date: May 2011

Study information

• Verified date: April 2011
• Source: Taipei Medical University WanFang Hospital
• Contact: Jia-Ying Sung, MD
• Phone: +886-2-2930-7930
• Email: 96317[@]wanfang.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Multiple Excitability Test
• Syndrome

Intervention

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

Procedure:
• Acupuncture
Acupuncture

Locations

Country	Name	City	State
Taiwan	Taipei Medical University - Wan Fang Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use QtracW and NCS to evaluate the changes between pre-treatment and post-treatment in patients in both arms.		12 weeks	No
Secondary	use BCTQ to evaluate the efficacy of 2 arms at week 4 and at week 12.		12 weeks	No
Secondary	use VAS to evaluate the efficacy of 2 arms at week 5, 8 and 12.		12 weeks	No
Secondary	Use Quality of Life questionnaire to compare the efficacy of 2 arms at week 12.		12 weeks	No
Secondary	Evaluate the safety of 2 arms during the study period		12 weeks	Yes