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
Secondary identifying numbers 170/03/t
Submission date
31/01/2006
Registration date
03/03/2006
Last edited
20/07/2010
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 Peter White
Scientific

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

Email pjw1@soton.ac.uk

Study information

Study designRandomised single blind placebo controlled multi-factorial trial with a nested qualitative study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Scientific title
Study objectives1. 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) studiedOsteoarthritis (OA)
InterventionPatients 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 typeOther
Primary outcome measurePain measured on a VAS
Secondary outcome measures1. Western Ontario and McMaster (WOMAC) University Osteoarthritis Index functional score
2. Nottingham Health profile
Overall study start date01/09/2003
Completion date01/09/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants288
Key inclusion criteria1. 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 criteria1. 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 enrolment01/09/2003
Date of final enrolment01/09/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

School of Health Professions
Southampton
SO17 1BJ
United Kingdom

Sponsor information

University of Southampton (UK)
University/education

Highfield
Southampton
SO17 1BJ
England
United Kingdom

Email jbk1@soton.ac.uk
ROR logo "ROR" https://ror.org/01ryk1543

Funders

Funder type

Government

Department of Health (UK) - Funded Trials for Complementary Alternative Medicine (CAM) (ref: 03/12)

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 30/04/2010 Yes No