Acupuncture in Patients With Carpal Tunnel Syndrome ~ A Randomized Controlled Trial
| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 13, 2009 |
| Last Updated Date | November 16, 2009 |
| Start Date ICMJE | July 2007 |
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Global symptoms score (GSS) [ Time Frame: Baseline, Month 1, 7, and 13 ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01014221 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
eletrophysiological parameters [ Time Frame: baseline, month 1 and 13 ] [ Designated as safety issue: No ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Acupuncture in Patients With Carpal Tunnel Syndrome ~ A Randomized Controlled Trial |
| Official Title ICMJE | Acupuncture in Patients With Carpal Tunnel Syndrome ~ A Randomized Controlled Trial |
| Brief Summary | To investigate the efficacy of acupuncture compared with steroid treatment in patients with mild-to-moderate carpal tunnel syndrome (CTS) as measured by objective changes in nerve conduction studies (NCS) and subjective symptoms assessment in a randomized, controlled study. |
| Detailed Description | A total of 77 consecutive and prospective CTS patients confirmed by NCS were enrolled in the study. Those who had fixed sensory complaint over the median nerve and thenar muscle atrophy were excluded. The CTS patients were randomly divided into 2 treatment arms: (1) 2 weeks of prednisolone 20 mg daily followed by 2 weeks of prednisolone 10 mg daily (n =39), and (2)acupuncture administered in 8 sessions over 4 weeks (n=38). A validated standard questionnaire as a subjective measurement was used to rate the 5 major symptoms (pain, numbness, paresthesia,weakness/clumsiness, and nocturnal awakening) on a scale from 0 (no symptoms) to 10 (very severe). The total score in each of the 5 categories was termed the global symptom score (GSS). Patients completed standard questionnaires at baseline and 2 and 4 weeks later. The changes in GSS were analyzed to evaluate the statistical significance. NCS were performed at baseline and repeated at the end of the study to assess improvement. All main analyses used intent-to-treat. |
| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Condition ICMJE | Carpal Tunnel Syndrome |
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 77 |
| Completion Date | September 2009 |
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria: presence of at least one of the following primary symptoms:
Exclusion Criteria:
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| Gender | Both |
| Ages | 20 Years to 80 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Taiwan |
| Administrative Information | |
| NCT Number ICMJE | NCT01014221 |
| Other Study ID Numbers ICMJE | 9612 |
| Has Data Monitoring Committee | No |
| Responsible Party | Yang, chun-pai/ Attending physician of Department of Neurology, Kuang Tien General Hospital |
| Study Sponsor ICMJE | Kuang Tien General Hospital |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Kuang Tien General Hospital |
| Verification Date | November 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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