Keele Research Repository

Background A randomized controlled trial (RCT) of stratified care demonstrated superior clinical outcomes and cost-effectiveness for low back pain (LBP) patients in UK primary care. This is the first study in Europe, outside of the original UK study, to investigate the clinical efficacy and cost-effectiveness of stratified care compared with current practice for patients with non-specific LBP. Methods The study was a two-armed RCT. Danish primary care patients with LBP were randomized to stratified care (n = 169) or current practice (n = 164). Primary outcomes at 3- and 12-months' follow-up were Roland Morris Disability Questionnaire (RDMQ), patient-reported global change and time off work. Secondary outcomes included pain intensity, patient satisfaction, healthcare resource utilization and quality-adjusted life years. Results Intention-to-treat analyses found no between-group difference in RMDQ scores at 3 months (0.5, 95% CI −1.8 to 0.9) or 12 months (0.4, −2.1 to 1.3). No overall differences were found between the arms at 3 and 12 months with respect to time off work or secondary outcomes. Stratified care intervention resulted in significantly fewer treatment sessions (3.5 [SD 3.1] vs. 4.5 [3.5]) and significantly lower total healthcare costs (€) (13.4 [529] vs. 228 [830], p = .002). There was no difference in cost-effectiveness (0.09, 0.05 to 0.13 vs. 0.10, 0.07–0.14, p = .70). Conclusions There was no significant difference in clinical outcomes between patients with non-specific LBP receiving stratified care and those receiving current practice. However, stratified care may reduce total healthcare costs if implemented in Danish primary care. Significance Stratified care for low back pain based on risk profile is recommended by recent evidence based clinical guidelines. This study is the first broad replication of the STarT Back Trial in Europe. Therefore, the study adds to the body of knowledge evaluating the effectiveness of stratified care for low back pain in primary care, and provides insight into the effects of stratification on clinical practice.