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| A pragmatic randomised controlled trial in primary care to determine the effectiveness of active physiotherapy treatment and enhanced pharmacy review for knee pain |
| Source of record | UK Trials |
| ISRCTN | ISRCTN55376150 |
| Date ISRCTN assigned | 03/01/2003 |
| Local reference number(s) | S0646 |
| Public title | A pragmatic randomised controlled trial in primary care to determine the effectiveness of active physiotherapy treatment and enhanced pharmacy review for knee pain |
| Scientific title | |
| Acronym | TOPIK (Treatment Options for Pain In the Knee) |
| Disease/condition/study domain | Knee pain |
| Study hypothesis | The primary objective of this trial is to examine the clinical effectiveness, of two innovative interventions: enhanced pharmacy review and active physiotherapy, compared with a control group receiving an advice and information booklet reinforced with telephone support. |
| 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 patients aged 55 years and above 2. Pain with or without stiffness in one or both knees 3. Considered suitable for primary care management by GP 4. Able to read English 5. Available for telephone contact 6. Able and willing to consent to participation |
| Participants - exclusion criteria | 1. Patients with potentially serious pathology (e.g. inflammatory arthritis, malignancy) on the basis of GP diagnosis or past medical history 2. Patients with severe disability: WOMAC Physical Function score ³ 40 3. Patients already on a surgical waiting list 4. Patients who have already had an exercise programme for their knee problem within the previous 3 months (normal recreational involvement in sport or exercise will not be an exclusion) 5. Patients who have received an intra-articular injection to the knee in the last 6 months 6. Patients who have a knee replacement 7. Patients unable or unwilling to receive the study interventions, or for whom the interventions are contraindicated 8. Patients with acute trauma 9. Knee pain due to malignancies |
| Patient information material | |
| Anticipated start date | 01/05/2001 |
| Anticipated end date | 31/03/2005 |
| Status of trial | Completed |
| Target number of participants | 325 |
| Interventions | 1. Pharmacy review of medication 2. Active physiotherapy management 3. Advice leaflet |
| Primary outcome measure(s) | Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 6 months. |
| Secondary outcome measure(s) | Anxiety and Depression (HADS); Confidence in managing pain, function, and other symptoms associated with arthritis (Arthritis Self-Efficacy Scale); Overall health status (EuroQoL). |
| Publications | Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17056608 |
| Sources of funding | Arthritis Research Campaign |
| 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 | Primary Care Sciences Research Centre Keele University Keele United Kingdom ST5 5BG |
| Contact telephone | +44 (0)1782 583908 |
| 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 | ISRCTN55376150 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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