Acupuncture Safety/Efficacy in Knee Osteoarthritis

This study has been completed.

First Received on February 2, 2001. Last Updated on March 5, 2008 History of Changes

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00010946

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 III

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:

MedlinePlus related topics: Acupuncture Acute Bronchitis Osteoarthritis

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:

Berman BM, Singh BB, Lao L, Langenberg P, Li H, Hadhazy V, Bareta J, Hochberg M. A randomized trial of acupuncture as an adjunctive therapy in osteoarthritis of the knee. Rheumatology (Oxford). 1999 Apr;38(4):346-54.

Berman BM, Lao L, Greene M, Anderson RW, Wong RH, Langenberg P, Hochberg MC. Efficacy of traditional Chinese acupuncture in the treatment of symptomatic knee osteoarthritis: a pilot study. Osteoarthritis Cartilage. 1995 Jun;3(2):139-42. No abstract available.

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 February 12, 2012