Acupuncture Safety/Efficacy in Knee Osteoarthritis

Phase 3

Completed

• Conditions: Osteoarthritis, Knee

• Registration Number: NCT00010946
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

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)

Detailed Description

Not available

Study Timeline

• Study Start: 1998-09
• Study First Submitted: 2001-02-02
• Study First Submitted QC: 2001-02-02
• Study First Posted: 2001-02-05
• Study Completion: 2003-08
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-05
• Last Update Posted: 2008-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

Catonsville Clinic; 🇺🇸 Catonsville, Maryland, United States

Kernan Hospital Mansion; 🇺🇸 Baltimore, Maryland, United States

Hospital for Special Surgery; 🇺🇸 New York, New York, United States