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Acupuncture Safety/Efficacy in Knee Osteoarthritis

NCT00010946 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2008-03-07

No results posted yet for this study

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

PROCEDURE

Acupuncture

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    lead NIH

Principal Investigators

  • Dr. Brian Berman · University of Maryland/Complementary Medicine Program

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-09-30
Completion
2003-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00010946 on ClinicalTrials.gov