A Randomised Controlled Trial (RCT) on Acupuncture Safety/Efficacy in Knee Osteoarthritis
| ISRCTN | ISRCTN83933522 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83933522 |
| ClinicalTrials.gov number | NCT00010946 |
| Secondary identifying numbers | UO1 AT 00171 |
- 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
Scientific
2200 Kernan Drive
Centre for Integrative Medicine
Baltimore, Maryland
21207
United States of America
| Phone | +1 410 448 6871 |
|---|---|
| bberman@compmed.umm.edu |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| 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 | 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 study start date | 01/09/1998 |
| Completion date | 31/08/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
21207
United States of America
Sponsor information
National Center for Complementary + Alternative Medicine (NCCAM), NI of Arthritis + Musculoskeletal + Skin Diseases (NIAMS)
Not defined
Not defined
NCCAM Clearinghouse
P.O. Box 7923
Gaithersburg, MD
20898
United States of America
"ROR" |
https://ror.org/00190t495 |
|---|
Funders
Funder type
Research organisation
National Center for Complementary and Alternative Medicine (NCCAM)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NCCAM
- Location
- United States of America
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- The National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH/National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Arthritis & Musculoskeletal & Skin Diseases, Instituto Nacional de Artritis y Enfermedades Musculoesqueléticas y de la Piel, NIAMS
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
