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| Integrated care in practice: Is acupuncture a useful adjunct to physiotherapy for older adults with knee pain? |
| Source of record | UK Trials |
| ISRCTN | ISRCTN88597683 |
| Date ISRCTN assigned | 03/01/2003 |
| Local reference number(s) | H0640 |
| Public title | Integrated care in practice: Is acupuncture a useful adjunct to physiotherapy for older adults with knee pain? |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Knee pain |
| Study hypothesis | To investigate whether acupuncture is a useful adjunct to advice and exercise for treating knee pain and gain insight into whether this effect is due to specific needling properties: 1. We will determine the additional benefit of true acupuncture when used by physiotherapists alongside advice and exercise for older people presenting to primary care with knee pain 2. We will evaluate sham acupuncture in the same way 3. We will investigate the treatment preferences and expectations of both the participants and physiotherapists participating in the study, and explore the effect of these on clinical outcome |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Male and female subjects aged 50 years and above 2. Pain with or without stiffness in one or both knees 3. Naive to acupuncture treatment (i.e., have never experienced acupuncture before for their present or any past complaints) 4. Considered suitable for referral to physiotherapy outpatients department 5. Able to read and write English, and to give full informed consent 6. Willing to consent to participation 7. Available for telephone contact |
| Participants - exclusion criteria | 1. Potentially serious pathology (e.g. inflammatory arthritis, malignancy etc) on the basis of general practice or physiotherapy diagnosis or from past medical history 2. Have had a knee or hip replacement on the affected side(s) 3. Are already on a surgical waiting list for total knee replacement 4. Trial interventions are contraindicated 5. Have received an exercise programme, from a physiotherapist, for their knee problem within the last three months (normal recreational involvement in sport or exercise will not be an exclusion) 6. Received an intra-articular injection to the knee in the last six months |
| Patient information material | |
| Anticipated start date | 01/11/2003 |
| Anticipated end date | 31/12/2006 |
| Status of trial | Completed |
| Target number of participants | 350 |
| Interventions | Acupuncture plus advice and exercise versus placebo acupuncture plus advice and exercise advice versus exercise alone. |
| Primary outcome measure(s) | Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at six months. |
| Secondary outcome measure(s) | 1. Knee-related pain 2. Movement and function 3. Pain intensity and effect 4. Main functional problem 5. Illness perceptions 6. Self-efficacy 7. Treatment preference and expectations 8. General health and quality of life |
| Publications | Protocol in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15345098 Results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17699546 |
| Sources of funding | Arthritis Research Campaign (UK) |
| Sponsor name | Arthritis Research Campaign (UK) |
| Sponsor details | Copeman House St Mary's Court St Mary's Gate Chesterfield Derbyshire United Kingdom S41 7TD |
| Sponsor email | info@arc.org.uk |
| Sponsor website | http://www.arc.org.uk |
| Contact name | Dr EM Hay |
| Contact details | Department of Rheumatology Haywood Hospital High Lane Burslem Stoke-on-Trent United Kingdom ST6 7AG |
| Contact telephone | +44 (0)1782 715444 |
| Contact email | e.m.hay@cphc.keele.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN88597683 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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