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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
History of Changes
  Purpose

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 Intervention Phase
Osteoarthritis, Knee
 Procedure: Acupuncture
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Acupuncture Safety/Efficacy in Knee Osteoarthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Study Start Date: September 1998
Estimated Study Completion Date: August 2003
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Dr. Brian Berman University of Maryland/Complementary Medicine Program
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00010946     History of Changes
Obsolete Identifiers: NCT00009490
Other Study ID Numbers: U01 AT000171-01M, 1 U01 AT000171-01
Study First Received: February 2, 2001
Last Updated: March 5, 2008
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
acupuncture
osteoarthritis
elderly

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

ClinicalTrials.gov processed this record on May 21, 2013