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

NCT00952432 | Unknown

• 1 other identifier: 2008WFCRC-07
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome; Multiple Excitability Test

Keywords

Carpal Tunnel Syndrome; Multiple Excitability Test; Nerve Conduction Study; QtracW; carbamazepine; Acupuncture

Outcome Measures

Primary Outcomes (1)

• Use QtracW and NCS to evaluate the changes between pre-treatment and post-treatment in patients in both arms.

  12 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

ACUPUNCTURE

ACTIVE COMPARATOR

ACUPUNCTURE

Procedure: Acupuncture

MEDICATION

ACTIVE COMPARATOR

Carbamazepine

Drug: Carbamazepine

Interventions

Carbamazepine DRUG

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

MEDICATION

Acupuncture PROCEDURE

Acupuncture

ACUPUNCTURE

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Taipei Medical University - Wan Fang Hospital

Taipei, Taiwan, 116, Taiwan

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Carbamazepine; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Complementary Therapies; Therapeutics

Study Officials

• Jia-Ying Sung, MD

  Taipei Medical University-Wan Fang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia-Ying Sung, MD

CONTACT

+886-2-2930-7930; 96317@wanfang.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 3, 2009
• First Posted: August 6, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: April 12, 2011

Record last verified: 2011-04

Locations

TW (1)