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脊髓刺激治疗持续性脊髓疼痛综合征的多学科方法:来自比利时神经疼痛®真实世界数据登记处的65个月综合数据收集。

Multidisciplinary Approach to Spinal Cord Stimulation for Persistent Spinal Pain Syndromes: A 65-Month Integrated Data Collection From the Belgian Neuro-Pain® Real-World Data Register.

作者信息

Bernaerts Lisa, Roelant Ella, Moens Maarten, Ly Huynh Giao, Buyten Jean-Pierre Van, Billet Bart, Bryon Bart, Puylaert Martine, Tuna Turgay, Malone Maureen, Theys Tom, Berquin Anne, Vangeneugden Johan, Hans Guy

机构信息

Multidisciplinary Pain Center, Antwerp University Hospital (UZA), Edegem, Belgium.

Laboratory of Pain Research, ASTARC, University of Antwerp (UA), Wilrijk, Belgium.

出版信息

Pain Res Manag. 2025 Aug 4;2025:7880611. doi: 10.1155/prm/7880611. eCollection 2025.

Abstract

Spinal cord stimulation (SCS) serves as a treatment option for neuropathic pain conditions. Despite its widespread use and technological advancements over the last decade, the long-term efficacy of SCS remains a topic of debate. Consequently, there is an increasing demand for real-world, long-term data regarding its effectiveness. In 2018, the Belgian government launched a nationwide platform to monitor all SCS therapies. Five and a half years after its start, a full data extraction was conducted. In the present study, we update the findings of Bernaerts et al. (2024) from the 3-week trial period and the long-term follow-up of patients with persistent spinal pain syndrome and focus on the completion rates of the follow-ups and the battery lifetime of the implantable pulse generators (IPGs). Findings indicate that "yellow flags" or psychological variables can be confirmed as significant predictors of recovery and satisfaction following the trial. Additionally, these yellow flags were able to predict long-term disability. Analysis revealed that patients who completed the follow-up module displayed more active and less passive coping strategies for their pain, along with lower levels of illness anxiety prior to the trial's start, better physical and psychological functioning, and greater recovery and satisfaction with the trial's outcomes. However, adherence to the chronic follow-up module declined over time. Moreover, we investigated the battery life of both rechargeable and nonrechargeable batteries across various indication types. The real-world dataset indicated no significant differences in battery lifetime between rechargeable and nonrechargeable IPGs for each indication type. The long-term outcomes of neuromodulation are intricate and influenced by various factors. Data extracted from the Neuro-Pain® registry increasingly enable us to identify confounding factors and predictors of treatment success with greater precision. ClinicalTrials.gov identifier: NCT06835868.

摘要

脊髓刺激(SCS)是治疗神经性疼痛疾病的一种选择。尽管在过去十年中其应用广泛且技术不断进步,但SCS的长期疗效仍是一个有争议的话题。因此,对于其有效性的真实世界长期数据的需求日益增加。2018年,比利时政府启动了一个全国性平台来监测所有SCS治疗。在启动五年半后,进行了一次完整的数据提取。在本研究中,我们更新了Bernaerts等人(2024年)关于持续性脊柱疼痛综合征患者3周试验期和长期随访的研究结果,并关注随访的完成率和植入式脉冲发生器(IPG)的电池寿命。研究结果表明,“黄旗”或心理变量可被确认为试验后恢复和满意度的重要预测因素。此外,这些黄旗能够预测长期残疾情况。分析显示,完成随访模块的患者在疼痛应对方面表现出更积极而非消极的策略,在试验开始前疾病焦虑水平更低,身体和心理功能更好,对试验结果的恢复和满意度更高。然而,对慢性随访模块的依从性随时间下降。此外,我们研究了不同适应症类型下可充电和不可充电电池的电池寿命。真实世界数据集表明,每种适应症类型的可充电和不可充电IPG的电池寿命没有显著差异。神经调节的长期结果复杂且受多种因素影响。从Neuro-Pain®注册中心提取的数据越来越使我们能够更精确地识别混杂因素和治疗成功的预测因素。ClinicalTrials.gov标识符:NCT06835868。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c633/12339138/54a5400d0bdf/PRM2025-7880611.001.jpg

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