Prospective, Multicenter Feasibility Study to Evaluate Differential Target Multiplexed Spinal Cord Stimulation Programming in Subjects With Chronic Intractable Back Pain With or Without Leg Pain
Prospective, Multicenter Feasibility Study to Evaluate Differential Target Multiplexed Spinal Cord Stimulation Programming in Subjects With Chronic Intractable Back Pain With or Without Leg Pain
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DOI：
10.1111/papr.12908
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发表时间：
2020-06-02
期刊：
影响因子：
2.6
通讯作者：
Vallejo, Ricardo
中科院分区：
文献类型：
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作者：
Fishman, Michael A.;Calodney, Aaron;Vallejo, Ricardo
目的：本前瞻性、开放标签、多中心研究评估脊髓刺激（SCS）治疗慢性腰痛方案的可行性，该方案使用多个电脉冲信号（差分目标复用）。方法在美国7个地点招募25名腰痛等于或大于下肢痛的SCS候选人。受试者评估标准和差分目标多路复用程序，每个4 +/- 1天。一个市售的SCS试验系统被用于标准的SCS治疗程序。在多路复用程序的试验期间，植入的临时导线连接到一个研究性的外部试验刺激系统。结果20名受试者完成研究。腰痛的平均基线数字疼痛评定量表（NPRS）评分为7.4，平均年龄为62.4岁，平均疼痛持续时间为18.0年。两种治疗均可显著缓解背痛，多路编程治疗效果更好。在试验期结束时，受试者报告他们的平均NPRS得分在标准编程后从基线降至4.2，在差分目标多路编程后降至2.4。标准编程和多路复用编程之间的差异是显著的。标准规划对腰痛缓解的应答率为50%，差异目标多路规划为80%。评估两种编程方法的85%的受试者更倾向于差分目标多路复用SCS。结论：在这个难以治疗的患者群体中，受试者报告使用多路编程显著减少了慢性背痛。需要一项随机临床试验来证实这项可行性研究的结果。
Objective This prospective, open-label, multicenter study evaluated the feasibility of spinal cord stimulation (SCS) therapy programming for chronic low back pain that uses multiple electrical pulsed signals (Differential Target Multiplexed).Methods Twenty-five SCS candidates with low back pain equal to or greater than lower limb pain were enrolled at 7 sites in the United States. The subjects evaluated standard and Differential Target Multiplexed programs, each for 4 +/- 1 days. A commercially available SCS trial system was used for standard SCS therapy programming. During the trialing of the multiplexed programs, implanted temporary leads were connected to an investigational external trial stimulator system.Results Twenty subjects concluded the study. The mean baseline numeric pain rating scale (NPRS) score for low back pain was 7.4, with a mean age of 62.4 years and mean pain duration of 18.0 years. Significant relief in back pain was observed for both treatments, with significantly better response with multiplexed programming. At the end of the trial period, subjects reported a reduction in their mean NPRS score from baseline to 4.2 after standard programming and to 2.4 after Differential Target Multiplexed programming. The difference between standard and multiplexed programming was significant. The responder rate for low back pain relief was 50% for standard programming and 80% for Differential Target Multiplexed programming. Eighty-five percent of subjects who evaluated both programming approaches preferred Differential Target Multiplexed SCS.Conclusion In this difficult-to-treat patient population, subjects reported significant reduction in chronic back pain when using multiplexed programming. A randomized clinical trial is needed to confirm the results from this feasibility study.