Background One model of care that has not been tested for chronic low back pain (LBP) is patient-led goal setting. We aimed to compare the clinical effectiveness and healthcare use of a patient-led goal setting approach (intervention) with simple advice to exercise (control) over 12 months.
Methods An assessor-blinded randomised controlled trial. Intervention was education combined with patient-led goal setting compared with a control group receiving a standardised exercise programme. The primary outcomes were back pain disability and pain intensity. Secondary outcomes were quality of life, kinesiophobia, self-efficacy, depression, anxiety and stress. Outcomes and healthcare use were assessed immediately post-treatment (2 months) and after 4 and 12 months. Analysis was by intention to treat.
Results Seventy-five patients were randomly assigned to either the intervention (n=37) or the control (n=38) group. Using linear mixed model analyses, adjusted mean changes in primary outcomes of disability and pain intensity were greater in the intervention group than in the control group (disability post-treatment: p<0.05). These differences were clinically meaningful. Mean differences in all secondary measures were greater in the intervention group than in the control group (p<0.05). There was no difference in healthcare use between groups over 12 months.
Conclusion A patient-led goal setting intervention was significantly more effective than advice to exercise for improving outcomes in disability, pain intensity, quality of life, self-efficacy and kinesiophobia in chronic LBP. These improvements were maintained at 12 months. Smaller effects were seen in measures of depression, anxiety and stress.
Trial registration number ACTRN12614000830695.
- lower back
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Contributors TG, KR, JM, SG and LS conceived the study and designed the study in collaboration. TG analysed the data and wrote the first draft of the manuscript. All authors interpreted the data and contributed to subsequent drafts of the manuscript, and all authors have seen and approved the final version.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Ethics approval Ethics approvals were obtained from the University of Sydney (HREC: 2014/572) and St Vincent’s Hospital, Sydney (HREC: 14/SVH/337) Human Research and Ethics Committees.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All of the individual participant data collected during the trial will be shared, after deidentification. Study protocol, statistical analysis plan and informed consent form will be made available. Data will be available beginning 3 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal. Proposals should be directed to email@example.com; to gain access, data requestors will need to sign a data access agreement.
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