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Acupuncture Safety/Efficacy in Knee Osteoarthritis

This study has been completed.
Study NCT00010946.   Last updated on March 5, 2008.   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

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Descriptive Information Fields
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)

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Osteoarthritis, Knee
Intervention  Procedure: Acupuncture
MEDLINE PMIDs 10378713,   7584319
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  September 1998
Completion Date August 2003
Eligibility Criteria 

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
Gender Both
Ages 50 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00010946
Organization ID U01 AT000171-01M
Secondary IDs †† 1 U01 AT000171-01
Study Sponsor  National Center for Complementary and Alternative Medicine (NCCAM)
Collaborators ††
Investigators 
Principal Investigator:     Dr. Brian Berman     University of Maryland/Complementary Medicine Program    
Information Provided By National Center for Complementary and Alternative Medicine (NCCAM)
Verification Date March 2008
First Received Date  February 2, 2001
Last Updated Date March 5, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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