Patient profiling and outcome assessment in spinal cord stimulation for chronic back and/or leg pain (the PROSTIM study): a study protocol

Abstract

Spinal cord stimulation (SCS) is a well-established treatment option in the multidisciplinary approach to chronic back and leg pain. Nevertheless, careful patient selection remains crucial to provide the most optimal treatment and prevent treatment failure. We report the protocol for the PROSTIM study, an ongoing prospective, multicentric and observational clinical study (NCT05349695) that aims to identify different patient clusters and their outcomes after SCS. Patients are recruited in different centers in Europe. Analysis focuses on identifying significant patient clusters based on different health domains and the changes in biopsychosocial variables 6 weeks, 3 and 12 months after implantation. This study is the first to include a biopsychosocial cluster analysis to identify significant patient groups and their response to treatment with SCS. What is the study about? Spinal cord stimulation (SCS) is a treatment for chronic back and leg pain, in which an electrical stimulation is delivered to the spinal cord in order to reduce pain experience. It is important to choose the right patients to make sure the treatment works well.The PROSTIM study is a research project in which we study patients selected to be treated with SCS. We want to understand how different groups of patients selected for this treatment do after getting SCS. The study includes patients in different European centers, following them for 6 weeks, 3 months and 1 year after getting SCS.This study is the first one to use a cluster analysis to group patients based on different aspects of their psychological and physical health and see how they respond differently to SCS treatment.Clinical Trial Registration: NCT05349695 (ClinicalTrials.gov)