Multicolumn Spinal Cord Stimulation for Significant Low Back Pain in Failed Back Surgery Syndrome: A National, Multicentre, Randomized, Controlled Health Economics Study (Estimet)

Abstract

IntroductionMany studies have demonstrated the efficacy of spinal cord stimulation (SCS) for chronic neuropathic radicular pain over recent decades. But despite global favorable outcomes in Failed Back Surgery Syndrome (FBSS) with leg pain, the back pain component remains poorly controlled by neurostimulation. Technological and scientific progress has led to the development of new SCS leads, comprising a multicolumn design and a greater number of contacts. Their efficacy of multicolumn SCS lead configurations for the treatment of the back pain component of FBSS has recently been suggested by pilot studies. However, a randomized controlled trial must be conducted to confirm the efficacy of new generation multicolumn SCS. ESTIMET is a multicentre, randomized study designed to compare the clinical efficacy and health economics aspects of mono vs multicolumn SCS lead programming in FBSS patients with radicular pain and significant back pain.Material and MethodsFBSS patients with a radicular pain VAS score ≥ 5...