通过EVOKE治疗在现实人群中使用ECAP剂量的临床实用性:ECAP研究
Jason E Pope1, Gregory L Smith2, Johnathan A Goree2
1Evolve Restorative Center, Santa Rosa, California, USA.
Regional anesthesia and pain medicine
|December 2, 2025
概括
关闭循环脊髓刺激系统EVOKE疗法在现实世界慢性疼痛患者中显示出显著的,持久的疼痛缓解. 这项研究证实了其在临床试验之外的有效性,在各种患者群体中显示出有意义的改善.
科学领域:
- 神经学 神经学
- 疼痛管理 疼痛管理
- 医疗器械 医疗器械
背景情况:
- 随机对照试验 (RCT) 显示EVOKE治疗对脊髓刺激 (SCS) 的有效性.
- 在现实世界中,RCT发现的概括性可能是有限的.
- 这项研究评估了EVOKE治疗在常规临床实践中的有效性.
研究的目的:
- 为了评估EVOKE治疗在现实世界慢性疼痛患者群体中的有效性.
- 评估EVOKE治疗在RCT中证明的疗效的概括性.
- 严格收集有关EVOKE疗法在常规临床环境中的性能数据.
主要方法:
- 未来,多中心,单臂,务实研究 (ECAP研究).
- 在22个美国地点招募了患有慢性,难治的干部/四肢疼痛的患者.
- 收集了PROMIS-29和神经生理学数据;使用临床重要差异最小值 (MCID) 进行分析.
主要成果:
- EVOKE治疗显示剂量比为1.3,神经剂量精度为2.8μV.
- 在所有领域都有超过1个MCID的改善;在七个领域中有六个领域≥2个MCID.
- 在植入后访问时改善或改善的改善;显著的整体MCID响应者 (p=0.047).
结论:
- EVOKE疗法为现实世界慢性疼痛患者提供了临床上有意义的改善.
- 在各种子组和疾病病理学中,疗效一致.
- 观察到的治疗效应从试验结束到植入后的随访持续.
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