The following is a summary of “Spinal Cord Stimulation for Failed Back Surgery Syndrome: to Trial or Not to Trial?,” published in the July 2023 issue of Pain by Witkam et al.
Spinal cord stimulation (SCS) is a highly recommended therapeutic intervention for managing failed back surgery syndrome (FBSS). A trial period is implemented to optimize patient selection. However, its underlying medical evidence is limited, particularly concerning the long-term efficacy and safety of the therapy. Researchers compared the long-term (5.3 ± 4.0 years) clinical outcome and security of a trialed and non-trialed implantation strategy, considering multidimensional variables and fluctuations in pain intensity over time. A multicenter cohort analysis was conducted on two comparable groups of patients with failed back surgery syndrome. Regarding eligibility, patients were required to undergo spinal cord stimulation treatment for at least 3 months.
The trial group consisted of patients who underwent a spinal cord stimulation implantation following a successful trial period. In contrast, the No-Trial group included patients who underwent complete implantation in a single session. The primary outcome measures assessed in this study were the scores indicating the intensity of pain experienced by the participants and any potential complications that arose. The trial and no-trial cohorts comprised 194 and 376 individuals (N = 570). A statistically, but not clinically, significant disparity in pain intensity (P = .003; effect = 0.506 (.172–.839)) was observed in favor of the Trial group. No correlation was observed between the presence of a time-dependent effect and the level of pain intensity. Compared to patients who underwent a spinal cord stimulation trial, those in the No-Trial group experienced a higher likelihood of discontinuing opioid usage (P = .003; odds ratio = .509 (.326–.792)). Conversely, patients in the No-Trial group had a lower incidence of infections (P = .006; proportion difference = .43 (.007–.083)).
While the clinical significance of the researcher’s findings needs to be validated in subsequent studies, this study utilizing long-term real-world data suggests the need for further investigation into patient-centered evaluations for determining the appropriateness of conducting a spinal cord stimulation trial. Based on the existing inconclusive evidence, evaluating SCS trials individually is advisable. In conjunction with the researcher’s findings, the current comparative evidence remains conclusive regarding which strategy for SCS implantation may be considered superior from a medical standpoint. A spinal cord stimulation trial should be evaluated individually, with the need for additional research into its clinical efficacy in specific patient populations or characteristics.