Improving Patient Choice in Treating Low Back Pain

ISRCTN	ISRCTN46035546
DOI	https://doi.org/10.1186/ISRCTN46035546
Protocol serial number	PB-PG-0808-17039
Sponsor	University of Warwick (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: 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

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Improving Patient Choice in Treating Low Back Pain: a cluster randomised controlled trial
Study acronym	IMPACT-LBP
Study objectives	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(s)	Warwickshire Research Ethics Committee (REC), 5th February 2010
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Satisfaction with treatment at three months using a five-point Likert Scale (very satisfied to very dissatisfied)
Key secondary outcome measure(s)	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.
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	158
Key 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
Key exclusion criteria	1. Severe psychiatric or personality disorders 2. Terminal illness 3. Critical illness 4. Possible serious spinal pathology including tumour, sepsis or fracture
Date of first enrolment	01/06/2010
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Warwick Clinical Trials Unit

Coventry
CV4 7AL
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	Date added	Peer reviewed?	Patient-facing?
Results article	results	21/08/2014		Yes	No
Protocol article	protocol	25/02/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes