Acupuncture Safety/Efficacy in Knee Osteoarthritis

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis, Knee

Treatments: Procedure: Acupuncture

Study type: Interventional

Funder types: NIH

Identifiers

NCT00010946

1U01AT000171-01 (U.S. NIH Grant/Contract)

U01 AT000171-01M

Details and patient eligibility

About

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)

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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