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

Study Overview
=================
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.

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

Conditions
-----------------
Carpal Tunnel Syndrome, Multiple Excitability Test

Intervention / Treatment
-----------------
* Drug: Carbamazepine
* Procedure: Acupuncture


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ACUPUNCTURE<br>ACUPUNCTURE | Procedure: Acupuncture<br>* Acupuncture<br>|
| Active Comparator: MEDICATION<br>Carbamazepine | Drug: Carbamazepine<br>* Carbamazepine 200mg, 1/2 tablet, TID for 1 month<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carpal Tunnel Syndrome, Multiple Excitability Test, Nerve Conduction Study, QtracW, carbamazepine, Acupuncture