Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PB-PG-0808-17039
Study information
Scientific title
Improving Patient Choice in Treating Low Back Pain: a cluster randomised controlled trial
Acronym
IMPACT-LBP
Study hypothesis
A 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
Warwickshire Research Ethics Committee (REC), 5th February 2010
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Back pain
Intervention
Curent 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 type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Satisfaction with treatment at three months using a five-point Likert Scale (very satisfied to very dissatisfied)
Secondary outcome measures
Measured 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 departments 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 trial start date
01/06/2010
Overall trial end date
31/12/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
158
Participant exclusion criteria
1. Severe psychiatric or personality disorders
2. Terminal illness
3. Critical illness
4. Possible serious spinal pathology including tumour, sepsis or fracture
Recruitment start date
01/06/2010
Recruitment end date
31/12/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Warwick Clinical Trials Unit
Coventry
CV4 7AL
United Kingdom
Sponsor information
Organisation
University of Warwick (UK)
Sponsor details
c/o Peter Hedges
University House
Coventry
CV4 7AL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0808-17039)
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
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21352528
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25146587
Publication citations
-
Protocol
Patel S, Brown S, Friede T, Griffiths F, Lord J, Ngunjiri A, Thistlethwaite J, Tysall C, Woolvine M, Underwood M, Study protocol: improving patient choice in treating low back pain (IMPACT-LBP): a randomised controlled trial of a decision support package for use in physical therapy., BMC Musculoskelet Disord, 2011, 12, 52, doi: 10.1186/1471-2474-12-52.
-
Results
Patel S, Ngunjiri A, Hee SW, Yang Y, Brown S, Friede T, Griffiths F, Lord J, Sandhu H, Thistlethwaite J, Tysall C, Underwood M, Primum non nocere: shared informed decision making in low back pain - a pilot cluster randomised trial., BMC Musculoskelet Disord, 2014, 15, 1, 282, doi: 10.1186/1471-2474-15-282.