The process of acupuncture: a randomised controlled trial and qualitative study to evaluate the relative contributions of specific and non-specific effects

ISRCTN	ISRCTN78434638
DOI	https://doi.org/10.1186/ISRCTN78434638
Protocol serial number	170/03/t
Sponsor	University of Southampton (UK)
Funder	Department of Health (UK) - Funded Trials for Complementary Alternative Medicine (CAM) (ref: 03/12)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Peter White
Scientific

School of Health Professions
University of Southampton
Highfield
Southampton
SO17 1BJ
United Kingdom

Email	pjw1@soton.ac.uk

Primary study design	Interventional
Study design	Randomised single blind placebo controlled multi-factorial trial with a nested qualitative study
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	1. Acupuncture is superior to placebo for the treatment of Osteo-Arthritic (OA) hip or knee 2. Empathic approach to treatment yields superior efficacy than a non-empathic approach 3. A needle-type placebo has a greater effect than a non-needle placebo
Ethics approval(s)	The Southampton and South West Hampshire Local Research Ethics Committee (LREC) approved on the 21st of August 2003 (ref: 170/03/t)
Health condition(s) or problem(s) studied	Osteoarthritis (OA)
Intervention	Patients are randomised to receive one of the following interventions: 1. Acupuncture which involves a course of treatment using a standardised but flexible choice of acupuncture points around the affected area and at distal points 2. Placebo acupuncture which involves using non-penetrating needles 3. Acupuncture-type treatment is also a placebo treatment and involves the use of a pseudo-electrical stimulation to acupuncture points via surface skin electrodes
Intervention type	Other
Primary outcome measure(s)	Pain measured on a VAS
Key secondary outcome measure(s)	1. Western Ontario and McMaster (WOMAC) University Osteoarthritis Index functional score 2. Nottingham Health profile
Completion date	01/09/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	288
Key inclusion criteria	1. Subjects aged between 18 and 80 2. Chronic or stable pain, predominantly from a single joint (hip or knee) of known mechanical aetiology i.e. osteo-arthritis 3. Score an average of 30 or more on the 100 mm visual analogue scale (VAS) in the pre-randomisation phase of the study 4. Not be on any active treatment (e.g. physiotherapy or homeopathy) 5. Ability to attend clinic twice a week for the duration of treatment
Key exclusion criteria	1. Pregnancy 2. Suffering serious co-morbidity (including severe back pain) 3. Prolonged or current steroid use 4. Waiting for hip/knee revision 5. Patients with needle phobia or allergy to sticking plaster
Date of first enrolment	01/09/2003
Date of final enrolment	01/09/2007

School of Health Professions

Southampton
SO17 1BJ
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	30/04/2010		Yes	No