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

Primary Purpose

Carpal Tunnel Syndrome, Multiple Excitability Test

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Carbamazepine
Acupuncture
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal Tunnel Syndrome, Multiple Excitability Test, Nerve Conduction Study, QtracW, carbamazepine, Acupuncture

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taipei Medical University - Wan Fang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ACUPUNCTURE

MEDICATION

Arm Description

ACUPUNCTURE

Carbamazepine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

use BCTQ to evaluate the efficacy of 2 arms at week 4 and at week 12.
use VAS to evaluate the efficacy of 2 arms at week 5, 8 and 12.
Use Quality of Life questionnaire to compare the efficacy of 2 arms at week 12.
Evaluate the safety of 2 arms during the study period

Full Information

First Posted
August 3, 2009
Last Updated
April 11, 2011
Sponsor
Taipei Medical University WanFang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00952432
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
May 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Taipei Medical University WanFang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Multiple Excitability Test
Keywords
Carpal Tunnel Syndrome, Multiple Excitability Test, Nerve Conduction Study, QtracW, carbamazepine, Acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACUPUNCTURE
Arm Type
Active Comparator
Arm Description
ACUPUNCTURE
Arm Title
MEDICATION
Arm Type
Active Comparator
Arm Description
Carbamazepine
Intervention Type
Drug
Intervention Name(s)
Carbamazepine
Intervention Description
Carbamazepine 200mg, 1/2 tablet, TID for 1 month
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture
Primary Outcome Measure Information:
Title
Use QtracW and NCS to evaluate the changes between pre-treatment and post-treatment in patients in both arms.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
use BCTQ to evaluate the efficacy of 2 arms at week 4 and at week 12.
Time Frame
12 weeks
Title
use VAS to evaluate the efficacy of 2 arms at week 5, 8 and 12.
Time Frame
12 weeks
Title
Use Quality of Life questionnaire to compare the efficacy of 2 arms at week 12.
Time Frame
12 weeks
Title
Evaluate the safety of 2 arms during the study period
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia-Ying Sung, MD
Phone
+886-2-2930-7930
Ext
6940
Email
96317@wanfang.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia-Ying Sung, MD
Organizational Affiliation
Taipei Medical University-Wan Fang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University - Wan Fang Hospital
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia-Ying Sung, MD
Phone
+886-2-2930-7930
Ext
6940
Email
96317@wanfang.gov.tw
First Name & Middle Initial & Last Name & Degree
Jia-Ying Sung, MD

12. IPD Sharing Statement

Learn more about this trial

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

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