The effectiveness of a stratified care model for non-specific low back pain in Danish primary care compared to current practice: study protocol of a randomised controlled trial

• Published in: Current controlled trials in cardiovascular medicine Vol. 19; no. 1; p. 315
• Main Authors: Morso, Lars, Schiøttz-Christensen, Berit, Søndergaard, Jens, Andersen, Nils-Bo de Vos, Pedersen, Flemming, Olsen, Kim Rose, Jensen, Morten Sall, Hill, Jonathan, Christiansen, David Høyrup
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 08.06.2018; BioMed Central; BMC
• Subjects: Back pain; Best practice; Care and treatment; Clinical trials; Control; Cost effectiveness; Costs; Data collection; Denmark; Digital signatures; Disability Evaluation; Health aspects; Health care costs; Humans; Intervention; Low back pain; Low Back Pain - diagnosis; Low Back Pain - therapy; Management; Pain Measurement; Patient Reported Outcome Measures; Patient satisfaction; Patient-Centered Care - methods; Patients; Physical therapy; Physical Therapy Modalities; Primary care; Primary Health Care; Quality of Life; Quality-Adjusted Life Years; Questionnaires; Randomised controlled trial; Randomized Controlled Trials as Topic; STarT back tool; Stratified care; Study Protocol; Time Factors; Treatment Outcome; Web portals; Denmark; United Kingdom > UK; STarT back tool; Cost effectiveness; Stratified care; Randomised controlled trial
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-018-2685-5

Prior studies indicate that stratified care for low back pain results in better clinical outcome and reduced costs in healthcare compared to current practice. Stratified care may be associated with clinical benefits for patients with low back pain at a lower cost, but evidence is sparse. Hence this study aims to evaluate the clinical effects and cost-effectiveness of stratified care in patients with non-specific low back pain compared to current practice. The study is a two-armed randomised controlled trial in primary care in the Regions of Southern and Central Denmark (2.5 million citizens). Patients with non-specific low back will be recruited by paticpating GPs. Patients are randomised to either (1) stratified care or (2) current practice at participating physiotherapy clinics. In the stratified care arm, the intervention is based on the patient's STarT Back Tool classification and trained accordingly, whereas physiotherapists in the current pratice arm are blinded to the STarT score. Primary outcomes in the trial will be group differences in time off work, improvement in LBP disability measured by the Roland Morris Disability Questionnaire (RMDQ) and patient-reported global change. Secondary measures will be pain intensity, patient satisfaction, data on patient healthcare resource utilisation and quality-adjusted life year based on the EQ-5D-5L. Stratified care that effectively targets treatment to relevant sub-groups of patients has potentially great impact on the treatment pathways of low back pain. Thus, if effective, this could result in better patient outcomes and at the same time reduce the costs for treatment of low back pain. ClinicalTrials.gov , NCT02612467 . Registered on 16 November 2015.