We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acupuncture Safety/Efficacy in Knee Osteoarthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00010946
First Posted: February 5, 2001
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
  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
Primary Purpose: Treatment
Official Title: Acupuncture Safety/Efficacy in Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

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

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 Submitted: February 2, 2001
First Posted: February 5, 2001
Last Update Posted: March 17, 2014
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