• Timothy R Deer, Steven M Falowski, Gregory A Moore, J Kelby Hutcheson, Isaac Peña, Kenneth Candido, Eric G Cornidez, von Und Zu Fraunberg, Bram Blomme, and Robyn A Capobianco.
• The Spine and Nerve Center of the Virginias, Charleston, WV.
• Spine. 2022 Apr 1; 47 (7): 548556548-556.

Study DesignProspective, international, multicenter, single-arm, post-market study.ObjectiveThe 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).Summary Of Background DataPassive 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.MethodsAfter a successful trial period, subjects received a permanent SCS implant and returned for follow-up at 6, 12, 18, and 24 months.ResultsSignificant 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 < 0.001) at all timepoints. Patient reported pain relief, a stated percentage of improvement in pain, was consistent at all timepoints at 60%. Patients reported significant improvements across all measures including activity levels and impact of pain on daily life. At 24 months, 84% of subjects were satisfied and 90% would recommend the procedure. Subjects decreased their chronic pain medication intake for all categories; 38% reduced psychotropic and muscle relaxants, 46% reduced analgesic, anti-convulsant and NSAIDs, and 48% reduced opioid medication. Adverse events occurred at low rates without unanticipated events.ConclusionEarly 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.Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.

9 keywords...

hide…