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

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.

Study Overview

• Status: Unknown
• Conditions: Carpal Tunnel Syndrome; Multiple Excitability Test
• Intervention / Treatment: Procedure: Acupuncture; Drug: Carbamazepine

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jia-Ying Sung, MD; Phone Number: 6940 +886-2-2930-7930; Email: 96317@wanfang.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 116
    • Recruiting
    • Taipei Medical University - Wan Fang Hospital
    • Contact: Jia-Ying Sung, MD; Phone Number: 6940 +886-2-2930-7930; Email: 96317@wanfang.gov.tw
    • Principal Investigator: Jia-Ying Sung, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Use QtracW and NCS to evaluate the changes between pre-treatment and post-treatment in patients in both arms.	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Investigators: Principal Investigator: Jia-Ying Sung, MD, Taipei Medical University-Wan Fang Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Anticipated): May 1, 2011
• Study Completion (Anticipated): May 1, 2011

Study Registration Dates

• First Submitted: August 3, 2009
• First Submitted That Met QC Criteria: August 4, 2009
• First Posted (Estimate): August 6, 2009

Study Record Updates

• Last Update Posted (Estimate): April 12, 2011
• Last Update Submitted That Met QC Criteria: April 11, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Acupuncture; carbamazepine; Carpal Tunnel Syndrome; Multiple Excitability Test; Nerve Conduction Study; QtracW
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anticonvulsants; Sodium Channel Blockers; Antimanic Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Carbamazepine
• Other Study ID Numbers: 2008WFCRC-07