Condition category
Musculoskeletal Diseases
Date applied
14/07/2004
Date assigned
19/10/2004
Last edited
18/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Brian M. Berman

ORCID ID

Contact details

2200 Kernan Drive
Centre for Integrative Medicine
Baltimore
Maryland
21207
United States of America
+1 410 448 6871
bberman@compmed.umm.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00010946

Protocol/serial number

UO1 AT 00171

Study information

Scientific title

Acronym

Study hypothesis

Added 18/08/09:
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 randomised controlled trial (RCT) using sham TCA, true TCA, and an education/attention comparison group is proposed. The primary hypothesis to be tested is that patients randomised 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 randomised to the sham acupuncture and education/attention control groups.

As of 18/08/09 this record has been updated. All updates can be found under the relavent field with the above update date.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Osteoarthritis

Intervention

Patients are randomised to one of three intervention groups:
1. Real Acupuncture
2. Sham Acupuncture
3. Health Education

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Added 18/08/09:
Improvement in pain and function as measured by the Womac Pain & Function Scales and patient global assessments

Secondary outcome measures

Added 18/08/09:
1. Determine if improvement with TCA differs between patients below age 65 vs. those aged 65 and above,
2. Determine if improvement with TCA differs by racial/ethnic group (ie., Caucasian, Black, Hispanic), and
3. Determine if improvement with TCA differs by stage of radiographic severity of knee OA at baseline (KL grade 2, 3 or 4)

Overall trial start date

01/09/1998

Overall trial end date

31/08/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. 570 Males and Females aged 50 and older
2. Diagnosis of osteoarthritis of the knee (fulfilling American College of Rheumatology [ACR] criteria) for at least 6 months duration
3. At least moderate pain in the knee for most days in the last month
4. Must be taking analgesic or nonsteroidal anti-inflammatory agents for control of pain
5. Documented radiographic changes of osteoarthritis - presence of osteophyte - at the time of rheumatological screening
6. Signed informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

570

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/09/1998

Recruitment end date

31/08/2003

Locations

Countries of recruitment

United States of America

Trial participating centre

2200 Kernan Drive
Baltimore, Maryland
21207
United States of America

Sponsor information

Organisation

National Center for Complementary + Alternative Medicine (NCCAM), NI of Arthritis + Musculoskeletal + Skin Diseases (NIAMS)

Sponsor details

NCCAM Clearinghouse
P.O. Box 7923
Gaithersburg
MD
20898
United States of America

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

National Center for Complementary and Alternative Medicine (NCCAM)

Alternative name(s)

NCCAM

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Funder name

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Alternative name(s)

NIAMS

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17308513

Publication citations

  1. Results

    Manheimer E, Lim B, Lao L, Berman B, Acupuncture for knee osteoarthritis--a randomised trial using a novel sham., Acupunct Med, 2006, 24 Suppl, S7-14.

Additional files

Editorial Notes