title: Efficacy of a Sleep Quality Intervention in People With Low Back Pain: Protocol for a Feasibility Randomized Co-Twin Controlled Trial.
abstract: 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.
authors: Faculty of Health Sciences,The University of Sydney,Sydney,New South Wales,Australia.
authors: Marina B
authors: MB
authors: Pinheiro
authors: Faculty of Health Sciences,The University of Sydney,Sydney,New South Wales,Australia.
authors: Kevin K
authors: KK
authors: Ho
authors: The George Institute for Global Health and Institute of Bone and Joint Research,The Kolling Institute,Sydney Medical School,The University of Sydney,Sydney,New South Wales,Australia.
authors: Manuela L
authors: ML
authors: Ferreira
authors: Faculty of Health Sciences,The University of Sydney,Sydney,New South Wales,Australia.
authors: Kathryn M
authors: KM
authors: Refshauge
authors: CIRUS,Centre for Sleep and Chronobiology,Woolcock Institute of Medical Research,University of Sydney and Royal Prince Alfred Hospital,NSW,Australia.
authors: Ron
authors: R
authors: Grunstein
authors: Centre for Epidemiology and Biostatistics,Melbourne School of Population and Global Health,The University of Melbourne,Melbourne,Victoria,Australia.
authors: John L
authors: JL
authors: Hopper
authors: The George Institute for Global Health,Sydney Medical School,The University of Sydney,Sydney,New South Wales,Australia.
authors: Christopher G
authors: CG
authors: Maher
authors: Department of General Practice,Erasmus MC,Rotterdam,The Netherlands.
authors: Bart W
authors: BW
authors: Koes
authors: Murcia Twin Registry,Department of Human Anatomy and Psychobiology,University of Murcia, and IMIB-Arrixaca,Murcia,Spain.
authors: Juan R
authors: JR
authors: Ordoñana
authors: Faculty of Health Sciences,The University of Sydney,Sydney,New South Wales,Australia.
authors: Paulo H
authors: PH
authors: Ferreira
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001315:Australia; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000150:complications / Q000235:genetics / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D012042:Registries; D012890:Sleep / Q000235:genetics*; D012893:Sleep Wake Disorders / Q000209:etiology / Q000235:genetics / Q000503:physiopathology; D014429:Twins, Dizygotic; D014430:Twins, Monozygotic
keywords: cognitive behavioral therapy; feasibility; insomnia; internet; low back pain; online; sleep; twins