Acupuncture for osteoarthritis of the knee: a pilot for a randomised controlled trial
| ISRCTN | ISRCTN25134802 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25134802 |
| Protocol serial number | N/A |
| Sponsor | University of York (UK) |
| Funder | Medical Research Council Health Services Research Collaboration, Research Initiative Grant (UK) |
- Submission date
- 22/06/2006
- Registration date
- 04/10/2006
- Last edited
- 18/02/2010
- 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 Hugh MacPherson
Scientific
Scientific
Department of Health Sciences
Seebohm Rowntree Area 3
Heslington
York
YO10 5DD
United Kingdom
| hm18@york.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A pilot for a randomised controlled trial. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | AOK |
| Study objectives | That a full-scale randomised controlled trial is feasible, and that the design can be optimised on the basis of the pilot |
| Ethics approval(s) | York Local Research Ethics Committee (reference no.:06/Q1108/30), approval received on 09/06/2006. |
| Health condition(s) or problem(s) studied | Osteoarthritis of the knee |
| Intervention | Group one: acupuncture plus usual General Practitioner (GP) care Group two: usual GP care alone |
| Intervention type | Other |
| Primary outcome measure(s) |
The impact of acupuncture on osteoarthritis of the knee will be measured using the WOMAC™ knee and hip osteoarthritis index, the Knee injury and Osteoarthritis Outcome Score (KOOS) and the Oxford knee score |
| Key secondary outcome measure(s) |
Quality of life will be assessed using the EuroQOL 5D Instrument (EQ-5D) |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | Patients over 50 years old who have consulted in primary care with a diagnosis of osteoarthritis of the knee and are experiencing ongoing pain and stiffness in the knee |
| Key exclusion criteria | 1. Currently receiving acupuncture 2. Pending litigation related to the knee 3. Under cancer care review 4. Haemophilia 5. Rheumatoid arthritis 6. Total knee or hip surgery on the affected side |
| Date of first enrolment | 01/07/2006 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Health Sciences
York
YO10 5DD
United Kingdom
YO10 5DD
United Kingdom
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 | 24/10/2009 | Yes | No |
