• Richard L Witkam, Elisabeth A M Kragt, ArntsInge J JIJJDepartment of Anaesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands., Ewald M Bronkhorst, Robert van Dongen, Erkan Kurt, SteegersMonique A HMAHDepartment of Anaesthesiology, Amsterdam University Medical Centers, Amsterdam, The Netherlands., Frank G A M van Haren, Natasja J G Maandag, Cees Gort, Dylan J H A Henssen, Jessica T Wegener, and VissersKris C PKCPDepartment of Anaesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands..
• Department of Anaesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands; Department of Neurosurgery, Radboud University Medical Center, Nijmegen, The Netherlands. Electronic address: Jesper.witkam@radboudumc.nl.
• J Pain. 2023 Jul 1; 24 (7): 129813061298-1306.

AbstractSpinal cord stimulation (SCS) is a recommended therapy to treat failed back surgery syndrome (FBSS). A trial period is practiced to enhance patient selection. However, its fundamental evidence is limited, especially concerning long-term benefit and therapy safety. We compared the long-term (5.3 ± 4.0 years) clinical outcome and therapy safety of a trialed and nontrialed implantation strategy, including multidimensional variables and pain intensity fluctuations over time. A multicenter cohort analysis was performed in 2 comparable groups of FBSS patients. Regarding eligibility, patients had to be treated with SCS for at least 3 months. While the Trial group comprised patients who underwent an SCS implantation after a successful trial, the No-Trial group encompassed patients who underwent complete implantation within 1 session. The primary outcome measures were pain intensity scores and complications. The Trial and No-Trial groups consisted of 194 and 376 patients (N = 570), respectively. A statistically but not clinically significant difference in pain intensity (P = .003; effect = 0.506 (.172-.839)) was found in favor of the Trial group. No interaction between a time dependency effect and pain intensity was noted. Whereas trialed SCS patients were more likely to cease opioid usage (P = .003; OR = .509 (.326-.792)), patients in the No-Trial group endured fewer infections (P = .006; proportion difference = .43 (.007-.083)). Although the clinical relevance of our findings should be proven in future studies, this long-term real-world data study indicates that patient-centered assessments on whether an SCS trial should be performed have to be investigated. According to the current ambiguous evidence, SCS trials should be considered on a case-by-case basis. PERSPECTIVE: The currently available comparative evidence, together with our results, remains ambiguous on which SCS implantation strategy might be deemed superior. An SCS trial should be considered on a case-by-case basis, for which further investigation of its clinical utility in certain patient populations or character traits is warranted.Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

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