Carpal Tunnel SyndromeNCT00952432
Compare the Efficacy of Acupuncture Therapy and Carbamazepine Oral Dosage in Patients With Carpal Tunnel Syndrome by Multiple Excitability Test
A study testing Carbamazepine and Acupuncture in people with Carpal Tunnel Syndrome and Multiple Excitability Test, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome, Multiple Excitability Test
- What is being tested?
- Carbamazepine and Acupuncture
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2009to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University - Wan Fang Hospital
Taipei, Taiwan, 116
Jia-Ying Sung, MD, +886-2-2930-7930 ext. 6940, 96317@wanfang.gov.tw
Jia-Ying Sung, MD
About this study
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
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
- Being tested
- Carbamazepine, Acupuncture
- Keywords
- Carpal Tunnel Syndrome, Multiple Excitability Test, Nerve Conduction Study, QtracW, carbamazepine, Acupuncture
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbamazepineDrug
Carbamazepine 200mg, 1/2 tablet, TID for 1 month
AcupunctureProcedure or surgery
Acupuncture
| Study group | Role | What they receive |
|---|---|---|
| ACUPUNCTURE | Active comparator | ACUPUNCTURE Receives: Procedure: Acupuncture |
| MEDICATION | Active comparator | Carbamazepine Receives: Drug: Carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use QtracW and NCS to evaluate the changes between pre-treatment and post-treatment in patients in both arms.
Measured: 12 weeks
Secondary outcomes (4)
use BCTQ to evaluate the efficacy of 2 arms at week 4 and at week 12.
Measured: 12 weeks
use VAS to evaluate the efficacy of 2 arms at week 5, 8 and 12.
Measured: 12 weeks
Use Quality of Life questionnaire to compare the efficacy of 2 arms at week 12.
Measured: 12 weeks
Evaluate the safety of 2 arms during the study period
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jia-Ying Sung, MD, Principal investigator, Taipei Medical University-Wan Fang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952432
- Sponsor's protocol ID
- 2008WFCRC-07
- Status last verified
- Apr 2011
- First submitted
- 3 Aug 2009
- Last updated
- 12 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00952432
- Acronym / sponsor ID
- 2008WFCRC-07
- Conditions
- Carpal Tunnel Syndrome, Multiple Excitability Test
- Keywords
- Carpal Tunnel Syndrome, Multiple Excitability Test, Nerve Conduction Study, QtracW, carbamazepine, Acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACUPUNCTURE | Active comparator | Procedure: AcupunctureACUPUNCTURE |
| MEDICATION | Active comparator | Drug: CarbamazepineCarbamazepine |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarbamazepineCarbamazepine 200mg, 1/2 tablet, TID for 1 month | Drug | MEDICATION |
| AcupunctureAcupuncture | Procedure or surgery | ACUPUNCTURE |
Primary outcome
Use QtracW and NCS to evaluate the changes between pre-treatment and post-treatment in patients in both arms.
Time frame: 12 weeks
4 secondary outcomes
use BCTQ to evaluate the efficacy of 2 arms at week 4 and at week 12.
Time frame: 12 weeks
use VAS to evaluate the efficacy of 2 arms at week 5, 8 and 12.
Time frame: 12 weeks
Use Quality of Life questionnaire to compare the efficacy of 2 arms at week 12.
Time frame: 12 weeks
Evaluate the safety of 2 arms during the study period
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia-Ying Sung, MD principal investigator
Taipei Medical University-Wan Fang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbamazepine and Acupuncture in people with Carpal Tunnel Syndrome and Multiple Excitability Test, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia-Ying Sung, MD (+886-2-2930-7930 ext. 6940, 96317@wanfang.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use QtracW and NCS to evaluate the changes between pre-treatment and post-treatment in patients in both arms. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2011.