Acupuncture Safety/Efficacy in Knee Osteoarthritis - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Acupuncture Safety/Efficacy in Knee Osteoarthritis

Official Title ^†

Acupuncture Safety/Efficacy in Knee Osteoarthritis

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

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Osteoarthritis, Knee

Intervention ^†

Procedure: Acupuncture

MEDLINE PMIDs

10378713, 7584319

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

September 1998

Completion Date

August 2003

Eligibility 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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00010946

Organization ID

U01 AT000171-01M

Secondary IDs ^††

1 U01 AT000171-01

Study Sponsor ^†

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^††

Investigators ^†

Principal Investigator:

Dr. Brian Berman

University of Maryland/Complementary Medicine Program

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

March 2008

First Received Date ^†

February 2, 2001

Last Updated Date

March 5, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.