Bernaerts Lisa, Roelant Ella, Lecomte Frederic, Moens Maarten, Van Buyten Jean-Pierre, Billet Bart, Bryon Bart, Puylaert Martine, Turgay Tuna, Malone Maureen, Theys Tom, Van Zundert Jan, Berquin Anne, Crombez Erwin, De Coster Olivier, Vangeneugden Johan, Ly Huynh Giao, Louagie Marleen, Hans Guy Henri
Multidisciplinary Pain Center, Antwerp University Hospital, Antwerp, Belgium.
Clinical Trial Center (CTC), CRC Antwerp, Antwerp University Hospital, Antwerp, Belgium.
Front Neurosci. 2024 Mar 22;18:1322105. doi: 10.3389/fnins.2024.1322105. eCollection 2024.
Spinal cord stimulation is a common treatment option for neuropathic pain conditions. Despite its extensive use and multiple technological evolutions, long term efficacy of spinal cord stimulation is debated. Most studies on spinal cord stimulation include a rather limited number of patients and/or follow-ups over a limited period. Therefore, there is an urgent need for real-world, long-term data.
In 2018, the Belgian government initiated a nationwide secure platform for the follow-up of all new and existing spinal cord stimulation therapies. This is a unique approach used worldwide. Four years after the start of centralized recording, the first global extraction of data was performed.
Herein, we present the findings, detailing the different steps in the centralized procedure, as well as the observed patient and treatment characteristics. Furthermore, we identified dropouts during the screening process, the reasons behind discontinuation, and the evolution of key indicators during the trial period. In addition, we obtained the first insights into the evolution of the clinical impact of permanent implants on the overall functioning and quality of life of patients in the long-term.
Although these findings are the results of the first data extraction, some interesting conclusions can be drawn. The long-term outcomes of neuromodulation are complex and subject to many variables. Future data extraction will allow us to identify these confounding factors and the early predictors of success. In addition, we will propose further optimization of the current process.
脊髓刺激是治疗神经性疼痛的一种常用方法。尽管其应用广泛且技术不断发展，但脊髓刺激的长期疗效仍存在争议。大多数关于脊髓刺激的研究纳入的患者数量相当有限，和/或随访时间有限。因此，迫切需要真实世界的长期数据。
2018年，比利时政府启动了一个全国性的安全平台，用于随访所有新的和现有的脊髓刺激疗法。这是一种在全球范围内独一无二的方法。在集中记录开始四年后，进行了首次全球数据提取。
在此，我们展示研究结果，详细介绍集中程序的不同步骤，以及观察到的患者和治疗特征。此外，我们确定了筛查过程中的退出者、停药原因以及试验期间关键指标的变化。此外，我们首次深入了解了永久性植入物对患者长期整体功能和生活质量的临床影响的演变。
尽管这些发现是首次数据提取的结果，但可以得出一些有趣的结论。神经调节的长期结果很复杂，受许多变量影响。未来的数据提取将使我们能够识别这些混杂因素和成功的早期预测因素。此外，我们将提出对当前流程的进一步优化。
