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11 February 2012
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| [ Print-friendly version ] |
| Improving Patient Choice in Treating Low Back Pain |
| ISRCTN | ISRCTN46035546 |
| ClinicalTrials.gov identifier | |
| Public title | Improving Patient Choice in Treating Low Back Pain |
| Scientific title | Improving Patient Choice in Treating Low Back Pain: a single centre randomised controlled trial |
| Acronym | IMPACT-LBP |
| Serial number at source | PB-PG-0808-17039 |
| 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 |
| Lay summary | Not provided at time of registration |
| Ethics approval | Warwickshire Research Ethics Committee (REC) pending as of 23/12/2009. |
| Study design | Single centre randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Back pain |
| Participants - 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 |
| Participants - exclusion criteria |
1. Severe psychiatric or personality disorders
2. Terminal illness 3. Critical illness 4. Possible serious spinal pathology including tumour, sepsis or fracture |
| Anticipated start date | 01/06/2010 |
| Anticipated end date | 31/05/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 150 |
| Interventions |
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 receive if you were not in the trial. |
| Primary outcome measure(s) | Satisfaction with treatment at three months using a five-point Likert Scale (very satisfied to very dissatisfied) |
| 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 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. |
| Sources of funding | National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0808-17039) |
| Trial website | |
| Publications | 1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21352528 |
| Contact name | Prof Martin Underwood |
| Address |
Warwick Clinical Trials Unit
University of Warwick Gibbet Hill Road |
| City/town | Coventry |
| Zip/Postcode | CV4 7AL |
| Country | United Kingdom |
| Sponsor | University of Warwick (UK) |
| Address |
c/o Peter Hedges
University House |
| City/town | Coventry |
| Zip/Postcode | CV4 7AL |
| Country | United Kingdom |
| Sponsor website: | http://www2.warwick.ac.uk |
| Date applied | 23/12/2009 |
| Last edited | 04/07/2011 |
| Date ISRCTN assigned | 11/02/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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