Implementing evidence based primary care for back pain
| ISRCTN | ISRCTN55174281 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55174281 |
| Secondary identifying numbers | 346/4540 |
- Submission date
- 22/06/2007
- Registration date
- 02/08/2007
- Last edited
- 28/09/2018
- 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
Prof Elaine Hay
Scientific
Scientific
Primary Care Musculoskeletal Research Centre
Keele University
Newcastle-under-Lyme
ST5 5BG
United Kingdom
| e.m.hay@cphc.keele.ac.uk |
Study information
| 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. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | IMplementation to improve Patient Care through Targeted treatment for Back pain (IMPaCT Back) |
| Study acronym | IMPaCT Back |
| Study objectives | 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. |
| Ethics approval(s) | 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). |
| Health condition(s) or problem(s) studied | Low back pain |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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. |
| Overall study start date | 01/10/2007 |
| Completion date | 01/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 1000 |
| Key inclusion criteria | Adults consulting their general practitioner for low back pain. |
| Key exclusion criteria | 1. Indication of "red flags" (potential serious pathology) 2. Unable to give informed consent |
| Date of first enrolment | 01/10/2007 |
| Date of final enrolment | 01/04/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Primary Care Musculoskeletal Research Centre
Newcastle-under-Lyme
ST5 5BG
United Kingdom
ST5 5BG
United Kingdom
Sponsor information
Keele University (UK)
University/education
University/education
Keele
Newcastle-under-Lyme
ST5 5BG
England
United Kingdom
| r.hughes@cphc.keele.ac.uk | |
| Website | http://www.keele.ac.uk |
"ROR" |
https://ror.org/00340yn33 |
Funders
Funder type
Charity
The Health Foundation (UK) (ref: 346/4540)
No information available
Keele University (UK)
No information available
Central and Eastern Cheshire Primary Care Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Other publications | explanation of treatment and training | 01/02/2012 | Yes | No | |
| Protocol article | protocol | 01/02/2012 | Yes | No | |
| Results article | results | 01/03/2014 | Yes | No |
Editorial Notes
28/09/2018: Publication reference added.
