一项关于10kHz高频脊髓刺激治疗慢性疼痛效果的单中心真实世界研究。
A single-center real-world review of 10 kHz high-frequency spinal cord stimulation outcomes for treatment of chronic pain.
作者信息
Ehsanian Reza, Wu Victor, Grandhe Radhika, Valeriano Matthew, Petersen Timothy R, Rivers W Evan, Koshkin Eugene
机构信息
Division of Pain Medicine, Department of Anesthesiology & Critical Care Medicine, University of New Mexico School of Medicine, Albuquerque, NM, USA.
University of New Mexico, School of Medicine, Albuquerque, NM, USA.
出版信息
Interv Pain Med. 2024 Mar 11;3(1):100402. doi: 10.1016/j.inpm.2024.100402. eCollection 2024 Mar.
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.
目的
在单一学术中心比较实用型真实世界10千赫高频脊髓刺激（HF-SCS）的结果与行业赞助的SENZA-RCT及施陶斯等人的研究结果。
方法
这项单中心回顾性研究纳入了2016年至2021年期间试用和/或永久植入Nevro HF-SCS系统的难治性背痛或肢体疼痛患者。人口统计学和结果数据来自电子病历（EMR）以及Nevro公司维护的真实世界全球数据库。从全球数据库获得的数据通过EMR进行了确认。主要结局指标包括阳性反应者状态（患者报告的疼痛减轻百分比（PRPPR）≥50%）、功能改善、睡眠改善以及止痛药物使用减少。比较组包括SENZA-RCT和施陶斯等人研究中的患者结局。
结果
对试用HF-SCS的患者（N = 147）进行了回顾，有137例患者的数据可用。试用患者的阳性反应率（PRPPR≥50%）为77%（106/137，95%置信区间70 - 84%），而施陶斯等人的研究为87%（1393/1607，95%置信区间85 - 89%），SENZA-RCT的HF-SCS为93%（90/97，95%置信区间88 - 98%）。在最后一次可用随访时，植入患者的阳性反应率为73%（58/80，95%置信区间63 - 82%），施陶斯等人的研究为78%（254/326，95%置信区间73 - 82%），SENZA-RCT的HF-SCS为79%（71/90，95%置信区间70 - 87%）。67%（59/88，95%置信区间57 - 77%）的患者报告功能改善，而施陶斯等人的研究为72%（787/1088，95%置信区间70 - 75%）；45%（31/69，95%置信区间33 - 57%）的患者报告睡眠改善，而施陶斯等人的研究为68%（693/1020，95%置信区间65 - 71%），16%（9/56，95%置信区间6 - 26%）的患者报告药物使用减少，而施陶斯等人的研究为32%（342/1070，95%置信区间29 - 35%）。
结论
在这项关于HF-SCS的回顾性实用型真实世界研究中，患者反应率与先前行业赞助的研究一致。然而，生活质量指标的改善和药物使用的减少不如行业赞助研究中报告的那么显著。这项非行业赞助的HF-SCS独立研究的结果通过报告在无行业赞助情况下收集的患者结局，对先前发表的研究结果起到了补充作用。
Zotero 插件