The Fear Reduction Exercised Early (FREE) approach to low back pain: study protocol for a randomised controlled trial

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.

Keywords: Brief intervention; Cost-effectiveness; General practice; Health-related quality of life; Impairment; Intervention study; Low back pain; Primary care; RCT; Treatment outcome.

Fig. 1

General practitioner (GP) trial process. FTE Full-time equivalent

Fig. 2

Patient participant trial processes. GP General practitioner, LBP Low back pain

Fig. 3

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure for patient participants. *Patient participants were assigned to intervention/control on the basis of allocation of the practice to which they presented (practices were randomized in this cluster randomized trial). ^†Assessments completed prior to general practitioner consultation and intervention or control exposure. RMDQ Roland-Morris Disability Questionnaire, NPRS Numeric Pain Rating Scale, NDRS Numeric Disability Rating Scale, EQ-5D EuroQol five dimensions, OCC-Q-LBP Otago Costs and Consequences Questionnaire, ACC Accident Compensation Corporation, FREE Fear Reduction Exercised Early, GP General practitioner

Fig. 4

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure for general practitioner participants. *General practitioners were enrolled between 4 weeks and 1 day pre-randomisation. ^†Allocation occurred between 5 weeks and 33 weeks before training was received. ^‡Time point when intervention group practices attended initial training workshops. ^§Assessment completed by intervention group participants only. FREE Fear Reduction Exercised Early, HC-PAIRS Health Care Providers’ Pain and Impairment Relationship Scale, Back-PAQ Back Pain Attitudes Questionnaire