Contact information
Type
Scientific
Primary contact
Dr Peter White
ORCID ID
Contact details
School of Health Professions
University of Southampton
Highfield
Southampton
SO17 1BJ
United Kingdom
pjw1@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
170/03/t
Study information
Scientific title
Acronym
Study hypothesis
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
The Southampton and South West Hampshire Local Research Ethics Committee (LREC) approved on the 21st of August 2003 (ref: 170/03/t)
Study design
Randomised single blind placebo controlled multi-factorial trial with a nested qualitative study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Pain measured on a VAS
Secondary outcome measures
1. Western Ontario and McMaster (WOMAC) University Osteoarthritis Index functional score
2. Nottingham Health profile
Overall trial start date
01/09/2003
Overall trial end date
01/09/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
288
Participant 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
Recruitment start date
01/09/2003
Recruitment end date
01/09/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Health Professions
Southampton
SO17 1BJ
United Kingdom
Sponsor information
Organisation
University of Southampton (UK)
Sponsor details
Highfield
Southampton
SO17 1BJ
United Kingdom
jbk1@soton.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Department of Health (UK) - Funded Trials for Complementary Alternative Medicine (CAM) (ref: 03/12)
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
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20433732
Publication citations
-
Results
Kersten P, White PJ, Tennant A, The visual analogue WOMAC 3.0 scale--internal validity and responsiveness of the VAS version., BMC Musculoskelet Disord, 2010, 11, 80, doi: 10.1186/1471-2474-11-80.