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Background Guidelines recommend a biopsychosocial framework for low back pain (LBP) management and the avoidance of inappropriate imaging. In clinical practice, care strategies are often inconsistent with evidence and guidelines, even though LBP is the most common disabling health condition worldwide. Unhelpful beliefs, attitudes and inappropriate imaging are common. LBP is understood to be a complex biopsychosocial phenomenon with many known multidimensional risk factors (symptom- and lifestyle-related, psychological and social) for persistent or prolonged disability, which should be identified and addressed by treatment. The STarT Back Tool (SBT) was developed for early identification of individual risk factors of LBP to enable targeted care. Stratified care according SBT has been shown to improve the effectiveness of care in a primary care setting. A biopsychosocially-oriented patient education booklet, which includes imaging guidelines and information, is one possible way to increase patients’ understanding of LBP and to reduce inappropriate imaging. Premeditated pathways, education of professionals, written material, and electronic patient registry support in health care organizations could help implement evidence-based care. Methods We will use a Benchmarking Controlled Trial (BCT) design in our study. We will prospectively collect data from three health care regions before and after the implementation of a classification-based approach to LBP in primary care. The primary outcome will be change in PROMIS (Patient-Reported Outcomes Measurement Information System) (short form 20a) over 12-month follow-up. Discussion The implementation of a classification-based biopsychosocial approach can potentially improve the care of LBP patients, reduce inappropriate imaging without increasing health-care costs, and decrease indirect costs by reducing work disability. Using the BCT we will be able to evaluate the effectiveness of the improvement strategy for the entire care pathway. Trial registration ISRCTN,ISRCTN13273552, retrospectively registered 13/05/2019.

Background Inappropriate imaging and low-value care for low back pain (LBP) are common. A new patient-education booklet was created to overcome identified barriers to the delivery of recommended care, including the use of inappropriate imaging. Our aim was to assess the effectiveness of this booklet as part of primary care for LBP patients in comparison to usual care. Methods A cluster-randomized trial was performed. The intervention involved providing practitioners with the new patient-education booklet and a 30-min training session on its use. The booklet was provided during the clinical consult to all consenting LBP patients in the intervention group. Primary outcomes were the proportion of patients presenting with LBP who underwent imaging examinations during the first three months of follow-up and PROMIS PF-20 (Patient-Reported Outcomes Measurement Information System, 20-item physical functioning short form) change between baseline and three-month follow-up. Secondary outcomes, including sick leave and imaging examinations at 12 months, were investigated. Logistic regression using GEE-estimation was used for dichotomous outcomes, Poisson regression using GEE-estimation for count outcomes, and linear mixed models for continuous outcomes. Results Using the patient education booklet appeared to substantially reduce the proportion of LBP patients who underwent an imaging examination at three months, but the result was not statistically significant (OR 0.57, 95% confidence interval (Cl) 0.27 to 1.22). At 12 months, the effect was slightly larger and statistically significant (OR 0.50, 95%Cl 0.30 to 0.83, p = 0.008). No difference was observed in the PROMIS PF-20 T-score change between baseline and 3 months or 12 months (p = 0.365 and p = 0.923, respectively). The number of sick leave days in the intervention group was less than that in the control group at 3 months (RR 0.47, 95%Cl 0.26 to 0.83, p = 0.010) and at 12 months (RR 0.36, 95%Cl 0.18 to 0.72, p = 0.004). Conclusions The booklet appeared to be effective in reducing the proportion of LBP patients who underwent imaging examinations over 12 months. The intervention had no discernible effect on the PROMIS PF20 T-score change. The number of sick leave days was substantially lower in the intervention group. Trial registration ISRCTN, ISRCTN14389368, Registered 4 April 2019—Retrospectively registered.