ABSTRACT
INTRODUCTION: Spinal cord stimulation (SCS) with lower thoracic leads has been studied extensively. However, the evidence base for cervical SCS is less well developed, and reports of multiarea SCS lead placement are uncommon. Therefore, this single-center retrospective study evaluated outcomes from 10-kHz SCS with cervical or combined cervical and thoracic lead placement. METHOD: All patients that underwent a 10-kHz SCS trial with either cervical or combined cervical and thoracic lead placement between 2015 and 2020 were included in our study. We reviewed patient's charts for demographic information, lead placement, and pain scores up to 48 months after implantation. RESULTS: Of the 105 patients that underwent a 10-kHz SCS trial during the review period, 92 (88%) had back/neck or extremity pain that responded to therapy (≥ 50% pain relief from baseline) and received a permanent system. Sixty-two of these patients (67%) were implanted with combined cervical and thoracic leads, while 30 (33%) received cervical-only leads. Pain relief in both regions exceeded 60% at most visits throughout the 48-month study period. Throughout follow-up, the responder rate in both pain areas was consistently ≥ 70%. No unexpected adverse events occurred. CONCLUSION: The 10-kHz SCS provided effective and durable pain relief with either cervical or combined cervical and thoracic leads. The efficacy and safety profile of both applications appears to be comparable to lower thoracic SCS. Our results suggest that 10-kHz SCS is a useful paresthesia-free therapeutic option for chronic neuropathic pain originating in the cervical area, as well as more complex multiarea pain presentations.
ABSTRACT
Objectives: High-frequency spinal cord stimulation (HF-SCS) at 10 kHz has proven to be efficacious in the treatment of chronic back and leg pain in a randomized, controlled, trial (SENZA-RCT). However, large observational studies have yet to be published. Therefore, we performed a real-world, multicenter, retrospective, review of therapy efficacy in 1660 patients with chronic trunk and/or limb pain. Methods: Data were collected in a real-world environment and retrospectively sourced from a global database. Included patients were trialed and/or permanently implanted with HF-SCS at 10 kHz between April 2014 and January 2018. We evaluated responder rates at 3, 6, and 12 months post-implantation. Response was defined as ≥50% pain relief from baseline. A last visit analysis included responder rate along with overall change in function, sleep, quality of life, and medication intake versus baseline. Results: Eighty-four percent of our HF-SCS-treated patients had both chronic back and leg pain. At least 70% of patients reported response to therapy throughout 12 months of follow-up. This sustained responder rate was corroborated by the last visit value (74.1%). Most patients reported concomitant improvements in function (72.3%), sleep (68.0%), and quality of life (90.3%) at their last visit versus baseline. Thirty-two percent of patients reported decreased medication intake at their last visit. Interpretation: Sustained and effective pain relief was experienced by >70% of our HF-SCS-treated patients, consistent with the findings of a previously published randomized, controlled, trial. Our review provides complementary evidence to support the treatment of chronic back and leg pain with this therapy.
