Efficacy of a Sleep Quality Intervention in People With Low Back Pain: Protocol for a Feasibility Randomized Co-Twin Controlled Trial

Poor sleep quality is highly prevalent in patients with low back pain (LBP) and is associated with high levels of pain, psychological distress, and physical disability. Studies have reported a bidirectional relationship between sleep problems and intensity of LBP. Accordingly, effective management of LBP should address sleep quality. In addition, genetics has been found to significantly affect the prevalence of both LBP and insomnia. Our study aims to establish the feasibility of a trial exploring the efficacy of a web-based sleep quality intervention in people with LBP, with the genetic influences being controlled for. 30 twins (15 complete pairs) with subacute or chronic LBP (>6 weeks) will be recruited from the Australian Twin Registry. Participants will be randomly assigned to one of the two groups with each twin within a pair receiving either an interactive web-based sleep intervention based on cognitive behavioral therapy principles (intervention) or a web-based education program (control) for 6 weeks. The feasibility of the trial will be investigated with regard to recruitment rate, feasibility of data collection and outcome measure completion, contamination of intervention, acceptability and experience of intervention, and sample size requirement for the full trial. Patient outcomes will be collected electronically at baseline, immediately post-treatment, and at 3-months’ follow-up post-randomization. This trial employs a robust design that will effectively control for the influence of genetics on treatment effect. Additionally, this study addresses sleep quality, a significant but under-explored issue in LBP. Results will inform the design and implementation of the definitive trial.