Condition category
Musculoskeletal Diseases
Date applied
22/06/2007
Date assigned
02/08/2007
Last edited
07/07/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.keele.ac.uk

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

  1. 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.

Additional files

Editorial Notes