Contact information
Type
Scientific
Primary contact
Prof Elaine Hay
ORCID ID
Contact details
Primary Care Musculoskeletal Research Centre
Keele University
Newcastle-under-Lyme
ST5 5BG
United Kingdom
e.m.hay@cphc.keele.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
346/4540
Study information
Scientific title
Acronym
IMPaCT Back
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.
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.
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/10/2007
Overall trial end date
01/04/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Adults consulting their general practitioner for low back pain.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
1000
Participant exclusion criteria
1. Indication of "red flags" (potential serious pathology)
2. Unable to give informed consent
Recruitment start date
01/10/2007
Recruitment end date
01/04/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Primary Care Musculoskeletal Research Centre
Newcastle-under-Lyme
ST5 5BG
United Kingdom
Sponsor information
Organisation
Keele University (UK)
Sponsor details
Keele
Newcastle-under-Lyme
ST5 5BG
United Kingdom
r.hughes@cphc.keele.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Health Foundation (UK) (ref: 346/4540)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Keele University (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Central and Eastern Cheshire Primary Care Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21708984
Publication citations
-
Protocol
Sowden G, Hill JC, Konstantinou K, Khanna M, Main CJ, Salmon P, Somerville S, Wathall S, Foster NE, , Targeted treatment in primary care for low back pain: the treatment system and clinical training programmes used in the IMPaCT Back study (ISRCTN 55174281)., Fam Pract, 2012, 29, 1, 50-62, doi: 10.1093/fampra/cmr037.