The process of acupuncture: a randomised controlled trial and qualitative study to evaluate the relative contributions of specific and non-specific effects
ISRCTN | ISRCTN78434638 |
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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
Scientific
School of Health Professions
University of Southampton
Highfield
Southampton
SO17 1BJ
United Kingdom
pjw1@soton.ac.uk |
Study information
Study design | Randomised single blind placebo controlled multi-factorial trial with a nested qualitative study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Quality of life |
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 | Pain measured on a VAS |
Secondary outcome measures | 1. Western Ontario and McMaster (WOMAC) University Osteoarthritis Index functional score 2. Nottingham Health profile |
Overall study start date | 01/09/2003 |
Completion date | 01/09/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
School of Health Professions
Southampton
SO17 1BJ
United Kingdom
SO17 1BJ
United Kingdom
Sponsor information
University of Southampton (UK)
University/education
University/education
Highfield
Southampton
SO17 1BJ
England
United Kingdom
jbk1@soton.ac.uk | |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 30/04/2010 | Yes | No |