NCT00010946

Acupuncture Safety/Efficacy in Knee Osteoarthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: National Center for Complementary and Integrative Health (NCCIH) · NIH
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
PROCEDURE	Acupuncture

Timeline

• Start date: 1998-09-01
• Completion: 2003-08-01
• First posted: 2001-02-05
• Last updated: 2008-03-07

Locations

3 sites across 1 country: United States