A single-center real-world review of 10 kHz high-frequency spinal cord stimulation outcomes for treatment of chronic pain

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Objective: To compare pragmatic real-world 10-kHz high-frequency spinal cord stimulation (HF-SCS) outcomes at a single academic center to the industry-sponsored SENZA-RCT and Stauss et al. study. Methods: This single-center retrospective study included patients with refractory back or limb pain trialed and/or permanently implanted with the Nevro HF-SCS system from 2016 to 2021. Demographic and outcome data were obtained from the electronic medical record (EMR) and real-world global database maintained by Nevro Corp. Data obtained from the global database were confirmed using the EMR. Main outcome measures included positive responder status (≥50% patient-reported percentage pain reduction (PRPPR)), improvement in function, improvement in sleep, and reduction in pain medication usage. Comparison groups included patient outcomes from the SENZA-RCT and Stauss et al. study. Results: Patients (N = 147) trialed with HF-SCS were reviewed, with data available for 137. Positive trialed patient responder rate (≥50% PRPPR) was 77% (106/137, 95CI 70-84%) vs. 87% (1393/1607, 95CI 85-89%) Stauss et al. vs. 93% (90/97, 95CI 88-98%) SENZA-RCT HF-SCS. At the last available follow-up, positive implanted patient responder rate was 73% (58/80, 95CI 63-82%) vs. 78% (254/326, 95CI 73-82%) Stauss et al. vs. 79% (71/90, 95CI 70-87%) SENZA-RCT HF-SCS. Sixty-seven percent (59/88, 95CI 57-77%) reported improved function vs. 72% (787/1088, 95CI 70-75%) Stauss et al.; 45% (31/69, 95CI 33-57%) reported improved sleep vs. 68% (693/1020, 95CI 65-71%) Stauss et al. and 16% (9/56, 95CI 6-26%) reported decrease in medication use vs. 32% (342/1070, 95CI 29-35%) Stauss et al. Conclusion: Patient responder rates in this retrospective pragmatic real-world study of HF-SCS are consistent with previous industry-sponsored studies. However, improvements in quality-of-life measures and reduction in medication usage were not as robust as reported in industry-sponsored studies. The findings of this non-industry-sponsored, independent study of HF-SCS complement those of previously published studies by reporting patient outcomes collected in the absence of industry sponsorship.

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