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

Lars Morso, Berit Schiøttz-Christensen, Jens Søndergaard, Nils-Bo de Vos Andersen, Flemming Pedersen, Kim Rose Olsen, Morten Sall Jensen, Jonathan Hill, David Høyrup Christiansen, Lars Morso, Berit Schiøttz-Christensen, Jens Søndergaard, Nils-Bo de Vos Andersen, Flemming Pedersen, Kim Rose Olsen, Morten Sall Jensen, Jonathan Hill, David Høyrup Christiansen

Abstract

Background: 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.

Methods/design: 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.

Discussion: 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.

Trial registration: ClinicalTrials.gov , NCT02612467 . Registered on 16 November 2015.

Keywords: Cost effectiveness; Randomised controlled trial; STarT back tool; Stratified care.

Conflict of interest statement

Authors’ information

LM is post-doctoral, BSC is a professor and MSJ a Ph.D. student at the Department of Regional Health Research, University of Southern Denmark, Odense. JS is a professor at the Research Unit of General Practice, University of Southern Denmark, Odense, FP and NBVA are physiotherapy primary care consultants for the regions of Southern and Central Denmark, KRO is an assisting professor at the Department of Business and Economics, COHERE, University of Southern Denmark, Odense, JH is an assisting professor at the Institute for Primary care and Health Sciences, Keele University, Staffordshire, UK, DHC is a post-doctoral at the Department of Occupational Medicine, Regional Hospital West Jutland, University Research Clinic, Denmark.

Ethics approval and consent to participate

Participation is based on informed consent. All patients in the study receive written and verbal information regarding the study. Consent for participation can at any time can be re-drawn and participation can be terminated without consequences for the patient. Patients who are not interested in participation in the project will be treated and referred in concordance with usual practice in primary care.

The study has been approved by the Scientific Ethics Committee of Southern Denmark (file no. S-20140205) and the Danish Data Protection Agency (file no. 15/3321). All rules of storage of personal information are met according to the Danish Data Protection Agency. Data will only be reported in anonymous form. Data management will be conducted according to the regional rules of the Region of Southern Denmark. The trial has been registered at ClinicalTrials.gov (Protocol Record S-20140205).

Consent for publication

All authors gave consent for publication.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of inclusion, treatment and follow-up
Fig. 2
Fig. 2
SPIRIT. Schedule of enrolment, assessment and interventions

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