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Acupuncture Safety/Efficacy in Knee Osteoarthritis
This study has been completed.
Study NCT00010946   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)
First Received: February 2, 2001   Last Updated: March 5, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

February 2, 2001
March 5, 2008
September 1998
 
 
Complete list of historical versions of study NCT00010946 on ClinicalTrials.gov Archive Site
 
 
 
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)

 
Phase III
Interventional
Treatment, Randomized, Single Blind
Osteoarthritis, Knee
Procedure: Acupuncture
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
August 2003
 

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
 
United States
 
 
NCT00010946
 
1 U01 AT000171-01
National Center for Complementary and Alternative Medicine (NCCAM)
 
Principal Investigator: Dr. Brian Berman University of Maryland/Complementary Medicine Program
National Center for Complementary and Alternative Medicine (NCCAM)
March 2008

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