An open pilot trial of the effects of acupuncture in the treatment of knee osteoarthritis.
ISRCTN | ISRCTN22366060 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN22366060 |
Secondary identifying numbers | N0265041788 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 04/06/2009
- 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 RW Jubb
Scientific
Scientific
Rheumatology
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Single-centre |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study objectives | In an open study, can acupuncture be shown to have an analgesic effect for patients with osteoarthritis of the knee? |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Knee osteoarthritis |
Intervention | Open pilot study looking at patients who have osteoarthritis of their knee and whose pain is not well-controlled on conventional treatment. The patients would be asked to take part for a period of 5 weeks. Possible patients must be over 18 years of age, not women of child-bearing age, not patients with pacemakers fitted. Patients will be randomised into one of three groups: 1. Patients receiving acupuncture alone 2. Patients receiving acupuncture as well as their conventional therapy 3. Patients continuing on their conventional therapy |
Intervention type | Other |
Primary outcome measure | 1. Patients Global Assessment of Efficacy 2. Investigator Global Assessment of Efficacy 3. 100m Visual Analogue Scale for Pain Assessment 4. WOMAC Index 5. Kellgren & Lawrence Scale for radiological assessment of osteoarthritis |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/07/2003 |
Completion date | 01/01/2007 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | 30 |
Key inclusion criteria | This is a pilot study - the size of any effect not known. Volunteers will be recruited from the rheumatology outpatients clinics at Selly Oak Hospital. We anticipate about 10 patients per group will be sufficient to enable a power calculation to be made. They must have osteoarthritis of the knee, and find that their pain is not well controlled by conventional medicine. They must be over 18 years of age. |
Key exclusion criteria | Patients will be excluded if they have any of the following: rheumatoid arthritis, Gout, psoriatic arthritis, osteoarthritis of the hip, patients with pacemakers fitted, patients with known metal allergies, patients with an history of prosthetic or damaged valves, patients with hemophilia, patients taking an anticoagulant or oral corticosteroid, patients suffering with dementia or other psychiatric disease, patients with Grade I or IV on the Kellgren & Lawrence scale, patients with uncontrolled diabetes and patients with a skin disease likely to affect the use of the acupuncture needles. |
Date of first enrolment | 01/07/2003 |
Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Rheumatology
Birmingham
B29 6JD
United Kingdom
B29 6JD
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
---|---|
dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
University Hospital Birmingham NHS Trust (UK)
No information available
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 | 01/03/2004 | Yes | No |