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

Rheumatology
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designSingle-centre
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesIn 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) studiedMusculoskeletal Diseases: Knee osteoarthritis
InterventionOpen 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 typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/07/2003
Completion date01/01/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants30
Key inclusion criteriaThis 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 criteriaPatients 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 enrolment01/07/2003
Date of final enrolment01/01/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Rheumatology
Birmingham
B29 6JD
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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