Short summary

Prior studies indicate that stratified care for low back pain results in better clinical outcome and reduced costs in healthcare compared to current practice.

The study  is a two-armed randomized controlled trial in primary care in the Regions of Southern and Central Denmark (2.5 million citizens).

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  praticed  arm are blinded to the STarT score.

Rationale

Emerging evidence indicates that stratified care of low back pain (LBP) may result in better clinical outcome and reduced healthcare costs, compared to usual care. Stratified care is a way to manage  the complexity of non-specific LBP. This approach involves a simple 9-item screening questionnaire, the STarT Back Tool (SBT). The SBT has earlier been translated and cross-culturally validated in a Danish speaking population. Using this tool  patients  are  assigned to one of three subgroups, based on modifiable  indicators of prolonged LBP, and then manage according to a matched treatment pathway. Patients are classified into low risk, medium risk and high risk subgroups based on the SBT score. Though, stratified care may be associated with clinical benefits for patients with low back pain at a lower cost, but evidence is sparse. 

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.

We will perform the study as a two-armed randomized controlled trial in primary health care from in the Regions of Southern and Central Denmark. Follow up points will be at 3 and 12 months.Patients are recruited by General Practitioners (GP) in 10 municipalities across Southern and Central Denmark Regions, a total of 42 GPs practices and 21 physiotherapy clinics  participate. At the initial or second consultation, the GP will assess, triage and electronically refer patients to physiotherapy according to their normal practice specified in the recommendations of the Danish Society of General Practice. Patients who decline referral will not be eligible for the study and will follow the usual clinical trajectory.

After receiving patients'  signed consent and baseline questionnaire the project secretary randomise the patients into one of the two treatment arms stratified by city and SBT sub-group using computer generated random number sequence. By randomization the patients in the study are ensured to receive treatment based at least on best practice. After randomization tthe relevant physiotherapy clinic is contacted to ensure initiation of treatment. At 3 and 12 months follow up questionnaires are electronically sent to the patient.

In the intervnetion group a structured standardised physical assessment will be performed. This include patient history concerns and treatment expectations and a core set of relevant physical tests (e.g. neurological examination if relevant, back pain movements and testing for a directional preference). The results of the clinical assessment, scores from questionnaires and the SBT sub-group classification in combination are used as clinical guidance and the appropriate matched treatment will be delivered accordingly to the patient's risk group. The treatment is delivered by physiotherapists who have received adequate training to deliver the stratified care.

In contrast to the stratified care group the decisions in ther control arm on whether patients should receive further physiotherapy treatment will be solely based on clinical judgement, clinical need and patient preferences. The physiotherapist has no access to any of the baseline patient questionnaires. Current best practice will be delivered by well-educated and qualified physiotherapists. 

Description of the cohort

Included are patients diagnosed with non-specific LBP and found relevant for referral to physiotherapy by the GP, 18 years and above, and understand Danish language. Patients with or without contributing leg pain can be included in the study. Patients  with non-specific low back will be recruited at the GP. Patients are randomized to either 1) Stratified care or 2) Current practice at participating physiotherapy clinics. 

Data and biological material

A core set of standardised and internationally recommended outcome measures will be applied in the trial. The primary outcomes in the trial will be improvement in LBP disability measured by the Roland Morris Disability Questionnaire (RMDQ), group differences in time off work and patient reported global change. Time off work is considered a complicated measure , but standardized patient reported data from the project database allows us to monitor short term sick leave (measured in days), and information from the Danish National Register on Public Transfer Payments (DREAM) makes it possible to monitor long term sick leave (>2 weeks of consecutive absence) and other related social benefits like pensions. Secondary outcomes will be pain intensity, patient satisfaction, data on patient health care resource utilization and EQ-5D-5L.

It is furthermore planned to monitor the stratified model's effectiveness on appropriateness of referrals- and ability to reduce referrals to secondary care. The outcome measures here will be numbers of referrals to secondary care using the stratified model compared to current practice, increased detail and usefulness of referrals sent to secondary care and numbers of consultations in secondary care for patients initially exposed to stratified care compared to current practice. 

Collaborating researchers and departments

Department of Regional Health Research, University of Southern Denmark, Odense; Spine Centre of Southern Denmark 

• Professor, Berit Schiøttz-Christensen, MD, PhD

Research Unit of General Practice, University of Southern Denmark, Odense 

• Professor, Jens Søndergaard, MD, PhD 

Department for Health Provision, Region of Central Denmark 

• Niels-Bo de Vos Andersen, Physiotherapist 

Physiotherapy Primary Care Consultant, Region of Southern Denmark, 

• Flemming Pedersen, Physiotherapist 

Department of Business and Economics, COHERE, University of Southern Denmark, Odense 

• Associate professor, Kim Olsen Rose, PhD

Institute for Primary Care and Health Sciences, Keele University ,Staffordshire, United Kingdom 

• Associate professor, Jonathan Hill, PhD

Department of Occupational Medicine, Regional Hospital West Jutland, University Research Clinic, Denmark

• Associate professor, David Høyrup Christiansen, PhD