| Source of record | UK Trials |
| ISRCTN | ISRCTN78434638 |
| Date ISRCTN assigned | 03/03/2006 |
| Local reference number(s) | 170/03/t |
| Public title | The process of acupuncture: a randomised controlled trial and qualitative study to evaluate the relative contributions of specific and non-specific effects |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Osteoarthritis (OA) |
| 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 |
| Design/methodology | Randomised, single-blind, placebo-controlled multi-factorial trial with a nested qualitative study |
| Research ethics review | Approved by the Southampton and South West Hampshire Local Research Ethics Committee (LREC) on 21/08/2003, reference number 170/03/t |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Subjects will be aged between 18 and 80 with chronic or stable pain, predominantly from a single joint (hip or knee) of known mechanical aetiology i.e. osteo-arthritis
Patients should:
a. Score an average of 30 or more on the 100 mm visual analogue scale (VAS) in the pre-randomisation phase of the study
b. Not be on any active treatment (e.g. physiotherapy or homeopathy)
c. Ability to attend clinic twice a week for the duration of treatment |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 01/09/2003 |
| Anticipated end date | 01/09/2007 |
| Status of trial | Completed |
| Target number of participants | 288 |
| Interventions | 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 |
| Primary outcome measure(s) | Pain measured on a VAS |
| Secondary outcome measure(s) | 1. Western Ontario and McMaster (WOMAC) University Osteoarthritis Index functional score
2. Nottingham Health profile |
| Sources of funding | Department of Health-Funded Trials for Complementary Alternative Medicine (CAM) 03/12 |
| Sponsor name | University of Southampton (UK) |
| Sponsor details | Highfield
Southampton
United Kingdom
SO17 1BJ |
| Sponsor email | jbk1@soton.ac.uk |
| Contact name | Dr Peter White |
| Contact details | School of Health Professions
University of Southampton
Highfield
Southampton
United Kingdom
SO17 1BJ |
| Contact email | pjw1@soton.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN78434638 |
| Date last extracted from ISRCTN register | 17/04/2008 |
