Abstract
BACKGROUND: Although it is broadly accepted that clinicians should endeavour to reassure patients with low back pain, to do so can present a significant clinical challenge. Guidance for how to provide effective reassurance is scarce and there may be a need to counter patient concerns arising from misinterpretation of spinal imaging findings. 'GLITtER' (Green Light Imaging Intervention to Enhance Recovery) was developed as a standardised method of communicating imaging findings in a manner that is reassuring and promotes engagement in an active recovery. This feasibility study is an important step towards definitive testing of its effect. METHODS: This feasibility study was a prospective, quasi-randomised, parallel trial with longitudinal follow-up, involving sampling of patients attending a spinal outpatient clinic at a metropolitan hospital. English speaking adults (18-75 years) presenting to the clinic with low back pain and prior spinal imaging were considered for inclusion. Eligible patients were allocated to receive a GLITtER consultation or a standard consultation (as determined by appointment scheduling and clinician availability), and were blinded to their allocation. Full details of the GLITtER intervention are described in accordance with the Tidier template.Follow-up data were collected after 1 and 3 months. The primary outcome of this study was the fulfillment of specific feasibility criteria which were established a priori. Determination of a sample size for a definitive randomised controlled trial was a secondary objective. RESULTS: Two hundred seventy-six patients underwent preliminary screening and 31 patients met the final eligibility criteria for study inclusion. Seventeen participants were allocated to the intervention group and 14 were allocated to the control group. Three month follow-up data were available from 42% of the 31 enrolled participants (N = 13, six intervention, seven control). Feasibility indicators for consent, resource burden and acceptability of the GLITtER intervention were met, however participant recruitment was slower than anticipated and an acceptable follow-up rate was not achieved. CONCLUSIONS: Failure to achieve pre-specified recruitment and follow-up rates were important outcomes of this feasibility study. We attribute failure to issues that are likely to be relevant for other clinical trials with this population. It is realistic to consider that these challenges can be overcome through careful strategy, ample funding and continued partnership with health care providers. TRIAL REGISTRATION: The trial was registered on the Australian and New Zealand Clinical Trials Registry on 28/2/2017 (ACTRN12617000317392).