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The Fear Reduction Exercised Early (FREE) approach to low back pain: study protocol for a randomised controlled trial.
Trials. 2017 Oct 17; 18(1):484.T

Abstract

BACKGROUND

Low back pain (LBP) is a major health issue associated with considerable health loss and societal costs. General practitioners (GPs) play an important role in the management of LBP; however, GP care has not been shown to be the most cost-effective approach unless exercise and behavioural counselling are added to usual care. The Fear Reduction Exercised Early (FREE) approach to LBP has been developed to assist GPs to manage LBP by empowering exploration and management of psychosocial barriers to recovery and provision of evidence-based care and information. The aim of the Low Back Pain in General Practice (LBPinGP) trial is to explore whether patients with LBP who receive care from GPs trained in the FREE approach have better outcomes than those who receive usual care.

METHODS/DESIGN

This is a cluster randomised controlled superiority trial comparing the FREE approach with usual care for LBP management with investigator-blinded assessment of outcomes. GPs will be recruited and then cluster randomised (in practice groups) to the intervention or control arm. Intervention arm GPs will receive training in the FREE approach, and control arm GPs will continue to practice as usual. Patients presenting to their GP with a primary complaint of LBP will be allocated on the basis of allocation of the GP they consult. We aim to recruit 60 GPs and 275 patients (assuming patients are recruited from 75% of GPs and an average of 5 patients per GP complete the study, accounting for 20% patient participant dropout). Patient participants and the trial statistician will be blind to group allocation throughout the study. Analyses will be undertaken on an intention-to-treat basis. The primary outcome will be back-related functional impairment 6 months post-initial LBP consultation (interim data at 2 weeks, 6 weeks and 3 months), measured with the Roland-Morris Disability Questionnaire. Secondary patient outcomes include pain, satisfaction, quality of life, days off from work and costs of care. Secondary GP outcomes include beliefs about pain and impairment, GP confidence, and actual and reported clinical behaviour. Health economic and process evaluations will be conducted.

DISCUSSION

In the LBPinGP trial, we will investigate providing an intervention during the first interaction a person with back pain has with their GP. Because the FREE approach is used within a normal GP consultation, if effective, it may be a cost-effective means of improving LBP care.

TRIAL REGISTRATION

Australian New Zealand Clinical Trials Registry, ACTRN12616000888460 . Registered on 6 July 2016.

Authors+Show Affiliations

Department of Primary Health Care and General Practice, University of Otago, Wellington, New Zealand. ben.darlow@otago.ac.nz.Biostatistical Group, Dean's Department, University of Otago, Wellington, New Zealand.Medical School, University of Exeter, Exeter, UK.Department of Surgical Sciences, University of Otago, Dunedin, New Zealand.Department of Primary Health Care and General Practice, University of Otago, Wellington, New Zealand.Department of Psychological Medicine, University of Otago, Wellington, New Zealand.Department of Primary Health Care and General Practice, University of Otago, Wellington, New Zealand.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29041947

Citation

Darlow, Ben, et al. "The Fear Reduction Exercised Early (FREE) Approach to Low Back Pain: Study Protocol for a Randomised Controlled Trial." Trials, vol. 18, no. 1, 2017, p. 484.
Darlow B, Stanley J, Dean S, et al. The Fear Reduction Exercised Early (FREE) approach to low back pain: study protocol for a randomised controlled trial. Trials. 2017;18(1):484.
Darlow, B., Stanley, J., Dean, S., Abbott, J. H., Garrett, S., Mathieson, F., & Dowell, A. (2017). The Fear Reduction Exercised Early (FREE) approach to low back pain: study protocol for a randomised controlled trial. Trials, 18(1), 484. https://doi.org/10.1186/s13063-017-2225-8
Darlow B, et al. The Fear Reduction Exercised Early (FREE) Approach to Low Back Pain: Study Protocol for a Randomised Controlled Trial. Trials. 2017 Oct 17;18(1):484. PubMed PMID: 29041947.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Fear Reduction Exercised Early (FREE) approach to low back pain: study protocol for a randomised controlled trial. AU - Darlow,Ben, AU - Stanley,James, AU - Dean,Sarah, AU - Abbott,J Haxby, AU - Garrett,Sue, AU - Mathieson,Fiona, AU - Dowell,Anthony, Y1 - 2017/10/17/ PY - 2017/07/17/received PY - 2017/09/29/accepted PY - 2017/10/19/entrez PY - 2017/10/19/pubmed PY - 2018/6/19/medline KW - Brief intervention KW - Cost-effectiveness KW - General practice KW - Health-related quality of life KW - Impairment KW - Intervention study KW - Low back pain KW - Primary care KW - RCT KW - Treatment outcome SP - 484 EP - 484 JF - Trials JO - Trials VL - 18 IS - 1 N2 - BACKGROUND: Low back pain (LBP) is a major health issue associated with considerable health loss and societal costs. General practitioners (GPs) play an important role in the management of LBP; however, GP care has not been shown to be the most cost-effective approach unless exercise and behavioural counselling are added to usual care. The Fear Reduction Exercised Early (FREE) approach to LBP has been developed to assist GPs to manage LBP by empowering exploration and management of psychosocial barriers to recovery and provision of evidence-based care and information. The aim of the Low Back Pain in General Practice (LBPinGP) trial is to explore whether patients with LBP who receive care from GPs trained in the FREE approach have better outcomes than those who receive usual care. METHODS/DESIGN: This is a cluster randomised controlled superiority trial comparing the FREE approach with usual care for LBP management with investigator-blinded assessment of outcomes. GPs will be recruited and then cluster randomised (in practice groups) to the intervention or control arm. Intervention arm GPs will receive training in the FREE approach, and control arm GPs will continue to practice as usual. Patients presenting to their GP with a primary complaint of LBP will be allocated on the basis of allocation of the GP they consult. We aim to recruit 60 GPs and 275 patients (assuming patients are recruited from 75% of GPs and an average of 5 patients per GP complete the study, accounting for 20% patient participant dropout). Patient participants and the trial statistician will be blind to group allocation throughout the study. Analyses will be undertaken on an intention-to-treat basis. The primary outcome will be back-related functional impairment 6 months post-initial LBP consultation (interim data at 2 weeks, 6 weeks and 3 months), measured with the Roland-Morris Disability Questionnaire. Secondary patient outcomes include pain, satisfaction, quality of life, days off from work and costs of care. Secondary GP outcomes include beliefs about pain and impairment, GP confidence, and actual and reported clinical behaviour. Health economic and process evaluations will be conducted. DISCUSSION: In the LBPinGP trial, we will investigate providing an intervention during the first interaction a person with back pain has with their GP. Because the FREE approach is used within a normal GP consultation, if effective, it may be a cost-effective means of improving LBP care. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12616000888460 . Registered on 6 July 2016. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/29041947/The_Fear_Reduction_Exercised_Early__FREE__approach_to_low_back_pain:_study_protocol_for_a_randomised_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2225-8 DB - PRIME DP - Unbound Medicine ER -