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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT00952432
First received: August 3, 2009
Last updated: April 11, 2011
Last verified: April 2011
  Purpose

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 Intervention
Carpal Tunnel Syndrome
Multiple Excitability Test
Drug: Carbamazepine
Procedure: Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:
  • Use QtracW and NCS to evaluate the changes between pre-treatment and post-treatment in patients in both arms. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • use BCTQ to evaluate the efficacy of 2 arms at week 4 and at week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • use VAS to evaluate the efficacy of 2 arms at week 5, 8 and 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Use Quality of Life questionnaire to compare the efficacy of 2 arms at week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Evaluate the safety of 2 arms during the study period [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: May 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ACUPUNCTURE
ACUPUNCTURE
Procedure: Acupuncture
Acupuncture
Active Comparator: MEDICATION
Carbamazepine
Drug: Carbamazepine
Carbamazepine 200mg, 1/2 tablet, TID for 1 month

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952432

Contacts
Contact: Jia-Ying Sung, MD +886-2-2930-7930 ext 6940 96317@wanfang.gov.tw

Locations
Taiwan
Taipei Medical University - Wan Fang Hospital Recruiting
Taipei, Taiwan, 116
Contact: Jia-Ying Sung, MD    +886-2-2930-7930 ext 6940    96317@wanfang.gov.tw   
Principal Investigator: Jia-Ying Sung, MD         
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Jia-Ying Sung, MD Taipei Medical University-Wan Fang Hospital
  More Information

No publications provided

Responsible Party: Jia-Ying Sung, Wan Fang Hospital
ClinicalTrials.gov Identifier: NCT00952432     History of Changes
Other Study ID Numbers: 2008WFCRC-07
Study First Received: August 3, 2009
Last Updated: April 11, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
Carpal Tunnel Syndrome
Multiple Excitability Test
Nerve Conduction Study
QtracW
carbamazepine
Acupuncture

Additional relevant MeSH terms:
Cumulative Trauma Disorders
Carpal Tunnel Syndrome
Syndrome
Disease
Median Neuropathy
Mononeuropathies
Nerve Compression Syndromes
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Peripheral Nervous System Diseases
Sprains and Strains
Wounds and Injuries
Carbamazepine
Analgesics
Analgesics, Non-Narcotic
Anticonvulsants
Antimanic Agents
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 27, 2014