Abstract
Abstract
Introduction
There is a need to develop approaches to reduce chronic pain after total knee replacement. There is an established link between disturbed sleep and pain. We tested the feasibility of a trial evaluating the clinical and cost-effectiveness of a pre-operative sleep assessment and complex intervention package for improving long-term pain after TKR.
Methodology
REST was a feasibility multi-centre randomised controlled trial with embedded qualitative study and health economics. Participants completed baseline measures and were randomised to usual care or the intervention, a tailored sleep assessment and behavioural intervention package delivered by an extended scope practitioner three months pre-operatively with a follow-up call up at four-weeks. Patient reported outcomes were assessed at baseline, one-week pre-surgery, and 3-months post-surgery.
Results
57 patients were randomised and 20 had surgery within the study timelines. All patients allocated the intervention attended an appointment and most engaged with treatment. The intervention group reported improvements in sleep (Sleep Conditions Indicator) and neuropathic pain (painDETECT) scores. Participants found the sleep treatments and study processes to be acceptable. The mean cost of the intervention was estimated at £134.45 per patient.
Conclusion
The feasibility study has shown that patient recruitment is feasible, engagement with and adherence to the intervention is high, and the intervention is acceptable to patients and clinicians. Preliminary findings show that the intervention group had improved sleep quality and had reduced levels of pre-operative neuropathic pain. This study has demonstrated that a full RCT is feasible and identified areas for improvement to optimize the trial design.
