The Sano study: justification and detailed description of a multidisciplinary biopsychosocial rehabilitation programme in patients with chronic low back pain

OBJECTIVE: To justify and describe an integrated rehabilitation programme for patients with chronic low back pain prior to evaluation in a randomized controlled trial. METHOD: The Template for Intervention Description and Replication (TIDieR) checklist was used as a structural framework for the description of the integrated rehabilitation programme. As a part of the description, the Medical Research Council guidance, ‘Developing and evaluating complex interventions’, was used as a framework to justify the integrated rehabilitation programme. INTERVENTION DESCRIPTION: The integrated rehabilitation programme adopts a participatory biopsychosocial approach integrating inpatient activities supported by a multidisciplinary team and learning located within the patient’s own environment. The integrated rehabilitation programme comprises 3 weeks of inpatient stay and 11 weeks of home-based activities. The inpatient part of the programme consists of 38 clinical activities, some of them delivered more than once. The 38 clinical activities were described in an activity sheet developed for this purpose, combining five items from the TIDieR. CONCLUSION: An integrated rehabilitation programme for patients with chronic low back pain has been justified and described. The intervention description is currently being used for successful structuring and standardization of the content and delivery of the integrated rehabilitation programme in a randomized controlled trial. TRAIL REGISTRATION: ClinicalTrials.gov: NCT02884466.