Passive Recharge Burst Spinal Cord Stimulation Provides Sustainable Improvements in Pain and Psychosocial Function: 2-year Results From the TRIUMPH Study.

Abstract

Prospective, international, multicenter, single-arm, post-market study. The aim of this study was to assess long-term safety and effectiveness of spinal cord stimulation using a passive recharge burst stimulation design for chronic intractable pain in the trunk and/or limbs. Herein we present 24-month outcomes from the TRIUMPH study (NCT03082261). Passive recharge burst spinal cord stimulation (B-SCS) uniquely mimics neuronal burst firing patterns in the nervous system and has been shown to modulate the affective and attentional components of pain processing. After a successful trial period, subjects received a permanent SCS implant and returned for follow-up at 6, 12, 18, and 24 months. Significant improvements in physical, mental, and emotional functioning observed after 6 months of treatment were maintained at 2 years. Pain catastrophizing scale (PCS) scores dropped below the population norm. Health-related quality of life on EQ-5D improved across all domains and the mean index score was within one standard deviation of norm. Pain reduction (on NRS) was statistically significant (P Early positive results with B-SCS were maintained long term. Evidence across multiple assessment tools show that B-SCS can alleviate pain intensity, psychological distress, and improve physical function and health-related quality of life.Level of Evidence: 3.