Improving Patient Choice in Treating Low Back Pain

ISRCTN ISRCTN46035546
DOI https://doi.org/10.1186/ISRCTN46035546
Secondary identifying numbers PB-PG-0808-17039
Submission date
23/12/2009
Registration date
11/02/2010
Last edited
26/08/2014
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 Martin Underwood
Scientific

Warwick Clinical Trials Unit
University of Warwick
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Study information

Study designCluster randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleImproving Patient Choice in Treating Low Back Pain: a cluster randomised controlled trial
Study acronymIMPACT-LBP
Study objectivesA decision support package designed for use in physiotherapy departments to help patients seeking care for their back pain will ensure better, more informed choices about their treatment and should improve patient satisfaction.

As of 09/09/2010 this record was updated to include extended trial dates; the initial dates at the time of registration were as follows:
Initial anticipated start date: 01/04/2010
Initial anticipated end date: 31/03/2012

Please note that as of 21/02/2013, the following changes were made to the trial record:
1. The scientific title was previously "Improving Patient Choice in Treating Low Back Pain: a single centre randomised controlled trial"
2. The target number of participants was updated from 150 to 158
3. The anticipated end date was updated from 31/05/2012 to 31/12/2012
Ethics approval(s)Warwickshire Research Ethics Committee (REC), 5th February 2010
Health condition(s) or problem(s) studiedBack pain
InterventionCurent interventions as of 21/02/2013:
Physiotherapists will be randomised to intervention or control. Those in the intervention arm will be trained on informed shared decision making which they will use during the consultation process. Physiotherapist NOT trained on informed shared decision making will continue to provide standard care that would normally be received if you were not in the trial.

Previous interventions until 21/02/2013:
Participants will be randomly allocated to one of the following two groups:
1. Physiotherapist trained on informed shared decision making: The physiotherapist will have been trained on informed shared decision making and they will use this during the consultation process.
2. Physiotherapist NOT trained on informed shared decision making: This will be standard care that would normally be received if you were not in the trial.
Intervention typeOther
Primary outcome measureSatisfaction with treatment at three months using a five-point Likert Scale (very satisfied to very dissatisfied)
Secondary outcome measuresMeasured at baseline and 3 months:
1. Roland Morris Disability Questionnaire (RMDQ) - the leading measure of LBP-related disability in primary care trials
2. Modified Von Korff - a measure of LBP and disability over the preceding month
3. 12-item short form health survey (SF-12) - a generic measure of health-related quality of life
4. EuroQol - a generic measure of health utility that is designed for use in RCTs
5. Hospital Anxiety and Depression Scale (HADS) - an established and validated self rating instrument for anxiety and depression
6. Pain Self-Efficacy Questionnaire (PSEQ) - an established measure self-efficacy for people with chronic pain
7. Fear Avoidance Beliefs Questionnaire (FABQ) - the physical sub-scale of FABQ measures attitude to movement in back pain
8. A question on change in ability to perform daily tasks
9. A question on change in low back pain since beginning treatment
10. Compliance - we will measure compliance from the physiotherapy department’s attendance records. We will also collect data from participants on health service use and health transition
11. Immediate follow-up assessment will focus on satisfaction with the decision making process. We will use the 'Satisfaction with Decision Scale' to measure satisfaction with the health care decision.
Overall study start date01/06/2010
Completion date31/12/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants158
Key inclusion criteria1. Patients seeking treatment for non specific low back pain
2. Aged greater than or equal to 18 years, either sex
3. Fluent spoken and written English
Key exclusion criteria1. Severe psychiatric or personality disorders
2. Terminal illness
3. Critical illness
4. Possible serious spinal pathology including tumour, sepsis or fracture
Date of first enrolment01/06/2010
Date of final enrolment31/12/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Warwick Clinical Trials Unit
Coventry
CV4 7AL
United Kingdom

Sponsor information

University of Warwick (UK)
University/education

c/o Peter Hedges
University House
Coventry
CV4 7AL
England
United Kingdom

http://www2.warwick.ac.uk
ROR logo https://ror.org/01a77tt86

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0808-17039)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 25/02/2011 Yes No
Results article results 21/08/2014 Yes No
BMC - Part of Springer Nature Springer Nature