Background: Multimodal rehabilitation and tailored behavioral medicine treatments should be provided to patients suffering from persistent and activity limiting pain according to current state-of-science. There is also evidence that a minimal intervention including 'stay-active advice' can produce effects comparable to effects of comprehensive treatment packages. Nevertheless, there is a gap of knowledge regarding which individuals who benefit the most from which modalities of pain treatment, at what time point, and with the highest cost-effectiveness. Accordingly, we have set up an innovative stepped-care protocol for the management of musculoskeletal pain in primary care, which is evaluated in a randomized controlled trial.

Objectives: The aim is to compare effects and cost-effectiveness of a stepped care model including advice and tailored behavioral medicine pain treatment (experimental condition) with a stepped care model including advice and physical exercises (comparison condition) for patients with low back and neck pain and/or widespread pain including fibromyalgia in primary care. A further aim is to characterize patients who benefit/do not benefit from the respective steps i.e. treatments varying in dose and content.

Methods: A stratified randomized stepped care design is applied. Stratification is based on primary care center and psychological risk profile. A consecutive selection is performed at primary care centers in southern, central and northern Sweden. After having received a minimal intervention (step 1) comprising 'stay-active advice', participants scoring high on the Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) according to preset criteria are randomly allocated to an eight-week treatment in step 2. The experimental condition includes supervised physical exercises integrated with either (a) graded activity, or (b) hierarchical graded exposure depending on psychological risk profile. The comparison condition includes supervised physical exercises irrespective of risk profile. Primary outcome is pain-related disability complemented with a comprehensive set of secondary outcomes adhering to the IMMPACT recommendations.

Results: The stepped-care design will be presented including illustrations of conclusions possible to draw with this kind of innovative design.

Conclusions: There is a call for stepped-care interventions within pain intervention research, particularly in the primary care setting. However, published studies are still lacking. This study will contribute to an important progression of behavioral medicine pain treatments by the way treatments are tailored in accordance with psychological risk profile. This will be discussed to stimulate research activities and collaboration within this area of research and clinical implementation.