Date Published: September 9, 2019
Publisher: Public Library of Science
Author(s): Ben Darlow, James Stanley, Sarah Dean, J. Haxby Abbott, Sue Garrett, Ross Wilson, Fiona Mathieson, Anthony Dowell, Adrian Christopher Traeger
Abstract: BackgroundEffective and cost-effective primary care treatments for low back pain (LBP) are required to reduce the burden of the world’s most disabling condition. This study aimed to compare the clinical effectiveness and cost-effectiveness of the Fear Reduction Exercised Early (FREE) approach to LBP (intervention) with usual general practitioner (GP) care (control).Methods and findingsThis pragmatic, cluster-randomised controlled trial with process evaluation and parallel economic evaluation was conducted in the Hutt Valley, New Zealand. Eight general practices were randomly assigned (stratified by practice size) with a 1:1 ratio to intervention (4 practices; 34 GPs) or control group (4 practices; 29 GPs). Adults presenting to these GPs with LBP as their primary complaint were recruited. GPs in the intervention practices were trained in the FREE approach, and patients presenting to these practices received care based on the FREE approach. The FREE approach restructures LBP consultations to prioritise early identification and management of barriers to recovery. GPs in control practices did not receive specific training for this study, and patients presenting to these practices received usual care. Between 23 September 2016 and 31 July 2017, 140 eligible patients presented to intervention practices (126 enrolled) and 110 eligible patients presented to control practices (100 enrolled). Patient mean age was 46.1 years (SD 14.4), and 46% were female. The duration of LBP was less than 6 weeks in 88% of patients. Primary outcome was change from baseline in patient participant Roland Morris Disability Questionnaire (RMDQ) score at 6 months. Secondary patient outcomes included pain, satisfaction, and psychosocial indices. GP outcomes included attitudes, knowledge, confidence, and GP LBP management behaviour. There was active and passive surveillance of potential harms. Patients and outcome assessors were blind to group assignment. Analysis followed intention-to-treat principles. A total of 122 (97%) patients from 32 GPs in the intervention group and 99 (99%) patients from 25 GPs in the control group were included in the primary outcome analysis. At 6 months, the groups did not significantly differ on the primary outcome (adjusted mean RMDQ score difference 0.57, 95% CI −0.64 to 1.78; p = 0.354) or secondary patient outcomes. The RMDQ difference met the predefined criterion to indicate noninferiority. One control group participant experienced an activity-related gluteal tear, with no other adverse events recorded. Intervention group GPs had improvements in attitudes, knowledge, and confidence compared with control group GPs. Intervention group GP LBP management behaviour became more guideline concordant than the control group. In cost-effectiveness, the intervention dominated control with lower costs and higher Quality-Adjusted Life Year (QALY) gains. Limitations of this study were that although adequately powered for primary outcome assessment, the study was not powered for evaluating some employment, healthcare use, and economic outcomes. It was also not possible for research nurses (responsible for patient recruitment) to be masked on group allocation for practices.ConclusionsFindings from this study suggest that the FREE approach improves GP concordance with LBP guideline recommendations but does not improve patient recovery outcomes compared with usual care. The FREE approach may reduce unnecessary healthcare use and produce economic benefits. Work participation or health resource use should be considered for primary outcome assessment in future trials of undifferentiated LBP.Trial registrationACTRN12616000888460
Partial Text: Low back pain (LBP) is a highly prevalent, complex, and expensive health condition and has been the world’s leading cause of disability since 1990 [1,2]. Globally, a substantial gap exists between current evidence on treating back pain and actual practice [3,4]. This gap results in overuse of opioid medication, spinal imaging, interventional procedures (such as guided injections), and surgery . Use of these interventions when not indicated provides poor value to both patients and health systems through overdiagnosis, overtreatment, and exposure to unnecessary risk of harm [3,5].
The trial was prospectively registered with the Australia New Zealand Clinical Trial Registry (ACTRN12616000888460) and is reported as per the Consolidated Standards Of Reporting Trials (CONSORT) guideline (S1 Checklist).
Fig 2 shows the trial profile. Between 6 July and 8 August 2016, 57 GP participants were enrolled and subsequently randomised in practice clusters. Full data collection dates are in the S1 Appendix (p 2). An additional 7 GPs (5 intervention, 2 control) were recruited after joining practices post randomisation (but prior to their practice’s study participation), and 1 GP who was on parental leave at the time of her practice’s study participation withdrew prior to recruiting any participants. One intervention group GP withdrew post-training (baseline GP data only), but full data were collected for all other GP participants. GP characteristics were reasonably balanced between groups (Table 1).
Findings from this trial suggest that patients with LBP who receive care from GPs trained in the FREE approach do not have improved disability or pain outcomes compared with those who receive usual care. In contrast, the FREE intervention improved GP attitudes, knowledge, and confidence and changed GP LBP management behaviours to be more guideline concordant. Economic evaluation was inconclusive but indicated the FREE approach may reduce the overall costs of LBP to the healthcare system and society.