Implementing evidence based primary care for back pain

ISRCTN	ISRCTN55174281
DOI	https://doi.org/10.1186/ISRCTN55174281
Protocol serial number	346/4540
Sponsor	Keele University (UK)
Funders	The Health Foundation (UK) (ref: 346/4540), Keele University (UK), Central and Eastern Cheshire Primary Care Trust (UK)

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

Primary Care Musculoskeletal Research Centre
Keele University
Newcastle-under-Lyme
ST5 5BG
United Kingdom

Email	e.m.hay@cphc.keele.ac.uk

Study information

Primary study design	Interventional
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.
Secondary study design	Non randomised controlled trial
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(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.
Key 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.
Completion date	01/04/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	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

United Kingdom
England

Study participating centre

Primary Care Musculoskeletal Research Centre

Newcastle-under-Lyme
ST5 5BG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/03/2014	Yes	No
Protocol article	protocol	01/02/2012	Yes	No
Other publications	explanation of treatment and training	01/02/2012	Yes	No

Editorial Notes

28/09/2018: Publication reference added.