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Acupuncture Safety/Efficacy in Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT00010946
Recruitment Status : Completed
First Posted : February 5, 2001
Last Update Posted : March 7, 2008
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Study Description
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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)


Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Procedure: Acupuncture Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Single
Primary Purpose: Treatment
Official Title: Acupuncture Safety/Efficacy in Knee Osteoarthritis
Study Start Date : September 1998
Study Completion Date : August 2003

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00010946


Locations
United States, Maryland
Kernan Hospital Mansion
Baltimore, Maryland, United States, 21207
Catonsville Clinic
Catonsville, Maryland, United States, 21228
United States, New York
Hospital for Special Surgery
New York, New York, United States
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Dr. Brian Berman University of Maryland/Complementary Medicine Program
More Information
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Publications:

ClinicalTrials.gov Identifier: NCT00010946     History of Changes
Obsolete Identifiers: NCT00009490
Other Study ID Numbers: U01 AT000171-01M
1U01AT000171-01 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2001    Key Record Dates
Last Update Posted: March 7, 2008
Last Verified: March 2008

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
acupuncture
osteoarthritis
elderly

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases