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Tracking Information | |||||
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First Received Date † | February 2, 2001 | ||||
Last Updated Date | March 5, 2008 | ||||
Start Date † | September 1998 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00010946 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Acupuncture Safety/Efficacy in Knee Osteoarthritis | ||||
Official Title † | Acupuncture Safety/Efficacy in Knee Osteoarthritis | ||||
Brief Summary | The goal of this research is to determine the efficacy and safety of Traditional Chinese Acupuncture (TCA) in patients with osteoarthritis of the knee. A three arm randomized controlled trial (RCT) using sham TCA, true TCA, and an education/attention comparison group with a total sample of 525 is proposed. Primary hypothesis to be tested is that patients randomized to true TCA will have significantly more improvement in pain and function as measured by the Womac Pain & Function Scales and patient global assessments than patients randomized to the sham acupuncture and education/attention control groups. Secondary aims of the study are to 1) determine if improvement with TCA differs between patients below age 65 vs. those aged 65 and above, 2) to determine if improvement with TCA differs by racial/ethnic group (ie., Caucasian, Black, Hispanic), and 3) to determine if improvement with TCA differs by stage of radiographic severity of knee OA at baseline (KL grade 2, 3 or 4) |
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Detailed Description | |||||
Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Single Blind | ||||
Condition † | Osteoarthritis, Knee | ||||
Intervention † | Procedure: Acupuncture | ||||
Study Arms / Comparison Groups | |||||
Publications * |
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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 † | Completed | ||||
Enrollment † | |||||
Completion Date | August 2003 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
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Gender | Both | ||||
Ages | 50 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00010946 | ||||
Responsible Party | |||||
Secondary IDs †† | 1 U01 AT000171-01 | ||||
Study Sponsor † | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
Verification Date | March 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |