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| [ ...Back to search results ] | [ Print-friendly version ] |
| Implementing evidence based primary care for back pain |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN55174281 |
| Date ISRCTN assigned | 02/08/2007 |
| Local reference number(s) | 346/4540 |
| Public title | Implementing evidence based primary care for back pain |
| Scientific title | |
| Acronym | IMPaCT Back |
| Disease/condition/study domain | Low back pain |
| Study hypothesis | Implementing a new system of sub-grouping and targeting treatment for Low Back Pain (LBP) in Primary Care will significantly improve clinical outcome and service provision. |
| Design/methodology | A pragmatic, interventional, implementation study to compare a new system of care with current practice (before implementation care) in a pre-post design. |
| Research ethics review | Approval being sought from the Cheshire LREC in September 2007. A favourable ethical opinion was received in the October 2007 meeting (ref: 07/H1017/143). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Adults consulting their general practitioner for low back pain. |
| Participants - exclusion criteria | 1. Indication of "red flags" (potential serious pathology) 2. Unable to give informed consent |
| Patient information material | |
| Anticipated start date | 01/10/2007 |
| Anticipated end date | 01/04/2010 |
| Status of trial | Ongoing |
| Target number of participants | 1000 |
| Interventions | There will be an initial observational phase, to gather data on current clinical practice, care pathways and patient outcomes. Intervention: A novel system of sub-grouping and targeting treatment on potentially modifiable physical and psychological risk factors for LBP recurrence and chronicity. Control: This will be compared with current clinical practice (before implementation care). The initial observational phase will take place over a four month period. Patients will be followed-up at two and six months after recruitment. The implementation of the new care system will take place over six months. There will then be a 12-month recruitment/observational phase, again with patient follow-up at two and six months. Time points for follow-up are at baseline, and two and six months after recruitment. Data will be collected through questionnaires sent directly to patients. We will be using a battery of validated self-complete instruments, including the Roland-Morris disability questionnaire (primary outcome), the 12-item Short Form (SF-12) general health measure, EuroQol, HAD (Hospital Anxiety-Depression Scale), the Tampa scale of kinesiophobia, fear avoidance beliefs questionnaire, sub-scales from the pain catastrophising instrument, individualised goal scaling and questions about pain and satisfaction. The exact format of the questionnaire is currently being finalised. |
| Primary outcome measure(s) | 1. Clinical outcome - back pain related disability (Roland-Morris questionnaire) 2. Clinical practice outcome - captured through questionnaires and medical record reviews 3. Service outcome - referral and re-consultation rates Outcomes will be assessed at baseline, two and six months. |
| Secondary outcome measure(s) | 1. Patient individualised goal attainment 2. Pain intensity 3. Global change in condition and general health status 4. Psychological health 5. Quality of Life 6. Utility 7. Healthcare usage 8. Satisfaction with care 9. Employment status 10. Changes in clinical practice 11. Changes in service provision Outcomes will be assessed at baseline, two and six months. |
| Sources of funding | 1. The Health Foundation (UK) (ref: 346/4540) 2. Keele University (UK) 3. Central and Eastern Cheshire Primary Care Trust (UK) |
| Sponsor name | Keele University (UK) |
| Sponsor details | Keele Newcastle-under-Lyme United Kingdom ST5 5BG |
| Sponsor email | r.hughes@cphc.keele.ac.uk |
| Sponsor website | http://www.keele.ac.uk |
| Contact name | Prof Elaine Hay |
| Contact details | Primary Care Musculoskeletal Research Centre Keele University Newcastle-under-Lyme United Kingdom ST5 5BG |
| 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 | ISRCTN55174281 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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