An open pilot trial of the effects of acupuncture in the treatment of knee osteoarthritis.

ISRCTN	ISRCTN22366060
DOI	https://doi.org/10.1186/ISRCTN22366060
Protocol serial number	N0265041788
Sponsor	Department of Health
Funder	University Hospital Birmingham NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr RW Jubb
Scientific

Rheumatology
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Single-centre
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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	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

Rheumatology

Birmingham
B29 6JD
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2004		Yes	No