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Acupuncture Safety/Efficacy in Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00010946
First received: February 2, 2001
Last updated: March 5, 2008
Last verified: March 2008

February 2, 2001
March 5, 2008
September 1998
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Complete list of historical versions of study NCT00010946 on ClinicalTrials.gov Archive Site
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Acupuncture Safety/Efficacy in Knee Osteoarthritis
Acupuncture Safety/Efficacy in Knee Osteoarthritis

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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Interventional
Phase 3
Allocation: Randomized
Masking: Single Blind
Primary Purpose: Treatment
Osteoarthritis, Knee
Procedure: Acupuncture
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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August 2003
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Inclusion Criteria:

  • Diagnosis of osteoarthritis of the knee (fulfilling ACR criteria) for at least 6 months duration
  • At least moderate pain in the knee for most days in the last month
  • Must be taking analgesic or nonsteroidal anti-inflammatory agents for control of pain
  • Documented radiographic changes of osteoarthritis (Kellgren-Lawrence grade>2) at the time of rheumatological screening
  • Signed informed consent
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00010946
U01 AT000171-01M, 1 U01 AT000171-01
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National Center for Complementary and Alternative Medicine (NCCAM)
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Principal Investigator: Dr. Brian Berman University of Maryland/Complementary Medicine Program
National Center for Complementary and Alternative Medicine (NCCAM)
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP