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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00010946 |
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)
Condition | Intervention | Phase |
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Osteoarthritis, Knee |
Procedure: Acupuncture |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind |
Official Title: | Acupuncture Safety/Efficacy in Knee Osteoarthritis |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
United States, Maryland | |
Catonsville Clinic | |
Catonsville, Maryland, United States, 21228 | |
Kernan Hospital Mansion | |
Baltimore, Maryland, United States, 21207 | |
United States, New York | |
Hospital for Special Surgery | |
New York, New York, United States |
Principal Investigator: | Dr. Brian Berman | University of Maryland/Complementary Medicine Program |
Study ID Numbers: | U01 AT000171-01M, 1 U01 AT000171-01 |
Study First Received: | February 2, 2001 |
Last Updated: | March 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00010946 History of Changes |
Health Authority: | United States: Federal Government |
acupuncture osteoarthritis elderly |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |