Bayerl Simon, Paz-Solis Jose, Matis Georgios, Rigoard Philippe, Kallewaard Jan Willem, Canos-Verdecho M Angeles, Vesper Jan, Llopis Jose Emilio, Kyriakopoulos Georgios, Gulve Ashish, Raoul Sylvie, Papa Alfonso, Love-Jones Sarah, Williams Adam
Inter Neuro Berlin, 10629 Berlin, Germany.
Department of Neurosurgery, Charite University Hospital, 10117 Berlin, Germany.
J Clin Med. 2024 Nov 20;13(22):6999. doi: 10.3390/jcm13226999.
Over the last 20 years, spinal cord stimulation (SCS) has seen the development of various paresthesia-free paradigms. Recently, a novel modality has emerged (Fast-Acting Sub-perception Therapy, FAST) that engages the surrounding inhibition mechanism of action. We evaluated long-term, real-world outcomes of preferential FAST-SCS use in patients with chronic pain. In this multi-center, observational, consecutive case series, medical chart data from chronic pain patients preferentially using FAST-SCS (no exclusions) were retrospectively reviewed. Data from 167 patients in 13 European centers were analyzed; 74% of patients suffered from persistent spine pain syndrome type 2 and 87% presented with low back and/or leg pain. At the last follow-up (mean 1.6 years), the numerical rating scale (NRS) overall pain score decreased by 5.1 ± 2.5 points versus baseline, from 8.0 ± 1.2 to 2.9 ± 2.2 (n = 167, < 0.0001). 87% of patients reported ≥50% pain relief, and 55% were "high responders" with overall NRS pain scores ≤2/10. At the last follow-up, functional disability improved significantly (the Oswestry Disability Index reduced by 29.2 ± 21.5 points, n = 65, < 0.0001) and patients had a significant gain in quality of life (EQ-5D-5L visual analog scale increased by 52.0 ± 26.9 points, n = 86, < 0.0001). Results at the 2-year follow-up showed a sustained, substantial reduction in pain; 67% of patients were high responders and the NRS overall pain score decreased by 5.6 ± 2.4 versus baseline (n = 52, < 0.0001). Our real-world outcomes suggest that in patients with chronic low back and/or leg pain, FAST-SCS therapy provided durable and profound pain relief and led to significant improvements in disability and quality of life.
在过去20年里，脊髓刺激（SCS）出现了多种无感觉异常模式。最近，一种新的模式（快速起效亚感知疗法，FAST）出现了，它利用周围抑制作用机制。我们评估了慢性疼痛患者优先使用FAST-SCS的长期实际效果。在这个多中心、观察性、连续病例系列中，对优先使用FAST-SCS（无排除标准）的慢性疼痛患者的病历数据进行了回顾性分析。分析了来自13个欧洲中心的167例患者的数据；74%的患者患有2型持续性脊柱疼痛综合征，87%的患者表现为腰和/或腿痛。在最后一次随访时（平均1.6年），数字评分量表（NRS）总体疼痛评分较基线下降了5.1±2.5分，从8.0±1.2降至2.9±2.2（n = 167，P<0.0001）。87%的患者报告疼痛缓解≥50%，55%为“高反应者”，NRS总体疼痛评分≤2/10。在最后一次随访时，功能障碍显著改善（奥斯威斯利功能障碍指数降低了29.2±21.5分，n = 65，P<0.0001），患者的生活质量有显著提高（EQ-5D-5L视觉模拟量表增加了52.0±26.9分，n = 86，P<0.0001）。2年随访结果显示疼痛持续大幅减轻；67%的患者为高反应者，NRS总体疼痛评分较基线下降了5.6±2.4（n = 52，P<0.0001）。我们的实际结果表明，对于慢性腰和/或腿痛患者，FAST-SCS疗法提供了持久而显著的疼痛缓解，并导致残疾和生活质量的显著改善。
