PDF(Pubmed)
Abstract：
While spinal cord stimulation (SCS) is a well-established therapy to address refractory persistent spinal pain syndrome after spinal surgery (PSPS-T2), its lack of spatial selectivity and reported discomfort due to positional effects can be considered as significant limitations. As alternatives, new waveforms, such as burst stimulation and different spatial neural targets, such as dorsal root ganglion stimulation (DRGS), have shown promising results. Comparisons between DRGS and standard SCS, or their combination, have never been studied on the same patients. \"BOOST DRG\" is the first prospective, randomized, double-blinded, crossover study to compare SCS vs. DRGS vs. SCS+DRGS. Sixty-six PSPS-T2 patients will be recruited internationally in three centers. Before crossing over, patients will receive each stimulation modality for 1 month, using tonic conventional stimulation. After 3 months, stimulation will consist in switching to burst for 1 month, and patients will choose which modality/waveform they receive and will then be reassessed at 6 and 12 months. In addition to our primary outcome based on pain rating, this study is designed to assess quality of life, functional disability, psychological distress, pain surface coverage, global impression of change, medication quantification, adverse events, brain functional imaging and electroencephalography, with the objective being to provide a multidimensional insight based on composite pain assessment.
摘要：
虽然脊髓刺激（SCS）是解决脊柱手术后难治性持续性脊柱疼痛综合征（PSPS-T2）的公认疗法，它缺乏空间选择性和报告的不适由于位置效应可以被认为是显著的限制。作为替代方案，新波形,如突发刺激和不同的空间神经目标，如背根神经节刺激（DRGS），已经显示出有希望的结果。DRGS和标准SCS之间的比较，或它们的组合，从未在同一患者身上进行过研究。“BOOSTDRG”是第一个预期的，随机化，双盲,比较SCS与SCS的交叉研究DRGSvs.SCS+DRGS。将在三个中心招募66名PSPS-T2患者。在穿越之前，患者将接受每种刺激方式1个月，使用补品常规刺激。三个月后,刺激将包括切换到爆发1个月，患者将选择接受的模态/波形，然后在6个月和12个月时重新评估。除了我们基于疼痛等级的主要结果，这项研究旨在评估生活质量，功能性残疾，心理困扰,疼痛表面覆盖，全球变化的印象，药物量化，不良事件,脑功能成像和脑电图，目的是提供基于复合疼痛评估的多维见解。
