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| Tracking Information | |||||
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| First Received Date ICMJE | November 27, 2006 | ||||
| Last Updated Date | May 6, 2008 | ||||
| Start Date ICMJE | December 2004 | ||||
| Primary Completion Date | January 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The changes in the pain score. [ Time Frame: wk52 ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
The changes in the pain score. | ||||
| Change History | Complete list of historical versions of study NCT00404443 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Acupuncture for the Treatment of Rheumatoid Arthritis | ||||
| Official Title ICMJE | Efficacy of Traditional Chinese Acupuncture in the Treatment of Rheumatoid Arthritis: a Double-Blind Controlled Pilot Study | ||||
| Brief Summary | To study the efficacy of acupuncture used as an adjunct measure for patients with refractory RA |
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| Detailed Description | The study employs a randomized, prospective, double-blind, placebo-controlled trial to evaluate the effect of electroacupuncture, traditional Chinese acupuncture and sham acupuncture in patients with refractory RA. All patients received 20 sessions over a period of 10 weeks. Six acupuncture points were chosen. Primary outcome is the changes in the pain score. Secondary outcomes included the changes in the ACR core disease measures, DAS 28 score and the number of patients who achieved ACR 20 at week 10. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Rheumatoid Arthritis | ||||
| Intervention ICMJE | Device: Acupuncture | ||||
| Study Arms / Comparison Groups | Sham Comparator: arm 1: placebo needle | ||||
| Publications * | Tam LS, Leung PC, Li TK, Zhang L, Li EK. Acupuncture in the treatment of rheumatoid arthritis: a double-blind controlled pilot study. BMC Complement Altern Med. 2007 Nov 3;7:35. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 36 | ||||
| Completion Date | January 2006 | ||||
| Primary Completion Date | January 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00404443 | ||||
| Responsible Party | Lai-Shan Tam, The Chinese University of Hong Kong | ||||
| Study ID Numbers ICMJE | TCM04001 | ||||
| Study Sponsor ICMJE | Chinese University of Hong Kong | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Chinese University of Hong Kong | ||||
| Verification Date | May 2008 | ||||
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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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