Effectiveness of coordinated care to reduce the risk of prolonged disability among patients suffering from subacute or recurrent acute low back pain in primary care: protocol of the CO.LOMB cluster-randomized, controlled study

BACKGROUND: Low back pain (LBP) is a common musculoskeletal condition and, globally, a leading cause of years lived with disability. It leads to reduced social participation, impaired quality of life, and direct and indirect costs due to work incapacity. A coordinated approach focusing on psychosocial risk factors, active reeducation, and the early use of tools to maintain employment, may be effective for improving prognosis of patients with LBP. Primary care professionals and multidisciplinary teams, who see patients in the early stages of LBP may be in the best position to implement such a coordinated approach. We designed this study to assess a coordinated multi-faceted strategy in primary care for patients with subacute or recurrent acute LBP. METHODS: The CO.LOMB study was designed as a multicentric, cluster-randomized, controlled study. Patients aged 18–60 years, with subacute or recurrent acute LBP are eligible. Patients also need to be employed (but can be on sick leave) with access to occupational health services. The clusters of GPs will be randomized (1:1) to either the Coordinated-care group or the Usual-care group. Patients will be assigned the group allocated to their GP. The healthcare professionals (GPs and associated physiotherapists) allocated to the Coordinated-care group will perform a 2-session study training. The following interventions are planned in the Coordinated-care group: exploration and management of psychosocial factors, active reeducation with a physiotherapist, the implementing of tools to maintain employment, and a reinforced cooperation between primary healthcare professionals. The primary objective is to assess the benefit of coordinated primary care to reduce disability in LBP patients at 12 months after enrollment: measure using the validated French version of the Roland Morris Disability Questionnaire. Secondary objectives include the evaluation of pain, work status, and quality of life at various time points. The study plans to enroll 500 patients in 20 GP clusters. Patients will be followed up for 12months. DISCUSSION: This study will evaluate the benefit of a coordinated multi-faceted strategy in primary care for patients with LBP. Notably whether this approach will alleviate the associated disability, attenuate pain, and promote the maintenance or return to work. CLINICAL TRIAL REGISTRATION: NCT04826757.