A Randomised Controlled Trial (RCT) on Acupuncture Safety/Efficacy in Knee Osteoarthritis

ISRCTN	ISRCTN83933522
DOI	https://doi.org/10.1186/ISRCTN83933522
ClinicalTrials.gov (NCT)	NCT00010946
Protocol serial number	UO1 AT 00171
Sponsor	National Center for Complementary + Alternative Medicine (NCCAM), NI of Arthritis + Musculoskeletal + Skin Diseases (NIAMS)
Funders	National Center for Complementary and Alternative Medicine (NCCAM), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Submission date: 14/07/2004
Registration date: 19/10/2004
Last edited: 18/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Brian M. Berman
Scientific

2200 Kernan Drive
Centre for Integrative Medicine
Baltimore, Maryland
21207
United States of America

Phone	+1 410 448 6871
Email	bberman@compmed.umm.edu

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Osteoarthritis
Intervention	Patients are randomised to one of three intervention groups: 1. Real Acupuncture 2. Sham Acupuncture 3. Health Education
Intervention type	Other
Primary outcome measure(s)	Added 18/08/09: Improvement in pain and function as measured by the Womac Pain & Function Scales and patient global assessments
Key secondary outcome measure(s)	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)
Completion date	31/08/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	570
Key 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
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/09/1998
Date of final enrolment	31/08/2003

Locations

Countries of recruitment

United States of America

Study participating centre

2200 Kernan Drive

Baltimore, Maryland
21207
United States of America

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2006		Yes	No