■将在单个学术中心的实际实际10kHz高频脊髓刺激(HF-SCS)结果与业界赞助的SENZA-RCT和Stauss等进行比较。study.
■这项单中心回顾性研究包括在2016年至2021年期间接受和/或永久植入NevroHF-SCS系统的难治性背部或四肢疼痛患者。人口统计学和结果数据是从NevroCorp.维护的电子病历(EMR)和现实世界的全球数据库中获得的使用EMR确认从全球数据库获得的数据。主要结局指标包括积极反应者状态(≥50%患者报告疼痛减轻百分比(PRPPR)),功能改进,改善睡眠,减少止痛药的使用。比较组包括SENZA-RCT和Stauss等人的患者预后。study.
■患者(N=147)接受HF-SCS试验,数据为137。试验阳性患者应答率(≥50%PRPPR)为77%(106/137,95CI70-84%)与87%(1393/1607,95CI85-89%)Stauss等人。vs.93%(90/97,95CI88-98%)SENZA-RCTHF-SCS。在最后一次可用的后续行动中,阳性植入患者反应率为73%(58/80,95CI63-82%)与78%(254/326,95CI73-82%)Stauss等人。vs.79%(71/90,95CI70-87%)SENZA-RCTHF-SCS。67%(59/88,95CI57-77%)报告功能改善与72%(787/1088,95CI70-75%)Stauss等人。;45%(31/69,95CI33-57%)报告睡眠改善与68%(693/1020,95CI65-71%)Stauss等人。和16%(9/56,95CI6-26%)报告的药物使用减少与32%(342/1070,95CI29-35%)Stauss等人。
■在HF-SCS的回顾性实际研究中,患者应答率与以前的行业赞助研究一致。然而,生活质量指标的改善和药物使用的减少并不像工业界赞助的研究中报道的那样稳健.这个非行业赞助的调查结果,HF-SCS的独立研究通过报告在没有行业赞助的情况下收集的患者结局来补充以前发表的研究.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.