Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0265041788
Study information
Scientific title
Acronym
Study hypothesis
In an open study, can acupuncture be shown to have an analgesic effect for patients with osteoarthritis of the knee?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Single-centre
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/07/2003
Overall trial end date
01/01/2007
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
30
Participant 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.
Recruitment start date
01/07/2003
Recruitment end date
01/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Rheumatology
Birmingham
B29 6JD
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospital Birmingham NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15077933
Publication citations
-
Results
Tukmachi E, Jubb R, Dempsey E, Jones P, The effect of acupuncture on the symptoms of knee osteoarthritis--an open randomised controlled study., Acupunct Med, 2004, 22, 1, 14-22.