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Implementing evidence based primary care for back pain
ISRCTN ISRCTN55174281
DOI 10.1186/ISRCTN55174281
ClinicalTrials.gov identifier
EudraCT number
Public title Implementing evidence based primary care for back pain
Scientific title
Acronym IMPaCT Back
Serial number at source 346/4540
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.
Lay summary Not provided at time of registration
Ethics approval 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).
Study design A pragmatic, interventional, implementation study to compare a new system of care with current practice (before implementation care) in a pre-post design.
Countries of recruitment United Kingdom
Disease/condition/study domain Low back pain
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
Anticipated start date 01/10/2007
Anticipated end date 01/04/2010
Status of trial Completed
Patient information material
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)
Trial website
Publications 1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21708984
Contact name Prof  Elaine  Hay
  Address Primary Care Musculoskeletal Research Centre
Keele University
  City/town Newcastle-under-Lyme
  Zip/Postcode ST5 5BG
  Country United Kingdom
  Email e.m.hay@cphc.keele.ac.uk
Sponsor Keele University (UK)
  Address Keele
  City/town Newcastle-under-Lyme
  Zip/Postcode ST5 5BG
  Country United Kingdom
  Email r.hughes@cphc.keele.ac.uk
  Sponsor website: http://www.keele.ac.uk
Date applied 22/06/2007
Last edited 07/07/2011
Date ISRCTN assigned 02/08/2007
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