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ISRCTN
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ISRCTN83933522
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ClinicalTrials.gov identifier
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NCT00010946
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Public title
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A Randomised Controlled Trial (RCT) on Acupuncture Safety/Efficacy in Knee Osteoarthritis
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Scientific title
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Acronym
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N/A
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Serial number at source
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UO1 AT 00171
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Study hypothesis
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Added 18/08/09:
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 randomised controlled trial (RCT) using sham TCA, true TCA, and an education/attention comparison group is proposed. The primary hypothesis to be tested is that patients randomised 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 randomised to the sham acupuncture and education/attention control groups.
As of 18/08/09 this record has been updated. All updates can be found under the relavent field with the above update date.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United States of America
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Disease/condition/study domain
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Osteoarthritis
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Participants - inclusion criteria
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1. 570 Males and Females aged 50 and older
2. Diagnosis of osteoarthritis of the knee (fulfilling American College of Rheumatology [ACR] criteria) for at least 6 months duration
3. At least moderate pain in the knee for most days in the last month
4. Must be taking analgesic or nonsteroidal anti-inflammatory agents for control of pain
5. Documented radiographic changes of osteoarthritis - presence of osteophyte - at the time of rheumatological screening
6. Signed informed consent
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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01/09/1998
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Anticipated end date
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31/08/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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570
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Interventions
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Patients are randomised to one of three intervention groups:
1. Real Acupuncture
2. Sham Acupuncture
3. Health Education
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Primary outcome measure(s)
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Added 18/08/09:
Improvement in pain and function as measured by the Womac Pain & Function Scales and patient global assessments
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Secondary outcome measure(s)
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Added 18/08/09:
1. Determine if improvement with TCA differs between patients below age 65 vs. those aged 65 and above,
2. Determine if improvement with TCA differs by racial/ethnic group (ie., Caucasian, Black, Hispanic), and
3. 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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Sources of funding
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1. National Center for Complementary and Alternative Medicine (NCCAM)
2. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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Trial website
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Publications
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2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17308513
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Contact name
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Dr
Brian M.
Berman
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Address
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2200 Kernan Drive
Centre for Integrative Medicine
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City/town
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Baltimore, Maryland
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Zip/Postcode
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21207
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Country
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United States of America
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Tel
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+1 410 448 6871
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Fax
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+1 410 448 875
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Email
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bberman@compmed.umm.edu
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Sponsor
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National Center for Complementary + Alternative Medicine (NCCAM), NI of Arthritis + Musculoskeletal + Skin Diseases (NIAMS)
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Address
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NCCAM Clearinghouse
P.O. Box 7923
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City/town
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Gaithersburg, MD
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Zip/Postcode
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20898
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Country
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United States of America
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Date applied
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14/07/2004
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Last edited
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18/08/2009
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Date ISRCTN assigned
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19/10/2004
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