Bellow Emily, Johnson Derek, Bajrami Sandi, Caldwell William
Department of Anesthesiology, Renaissance School of Medicine at Stony Brook University, Stony Brook, NY, USA.
Interv Pain Med. 2025 Aug 14;4(3):100624. doi: 10.1016/j.inpm.2025.100624. eCollection 2025 Sep.
The Intracept procedure was the first FDA-cleared technique for basivertebral nerve ablation, a minimally invasive treatment for vertebrogenic chronic low back pain. While prior studies support its effectiveness, data in patients with osteoporosis and osteopenia remains limited.
To evaluate the safety and effectiveness of basivertebral nerve ablation with a specific focus on pain reduction, functional improvement, and the incidence of post-procedure vertebral compression fractures.
A retrospective chart review was conducted on patients who underwent the Intracept procedure at our institution from November 2019 to January 2025. Bone density status was categorized using available DEXA scans. Patients were stratified into a Reduced Bone Density group (N = 32), consisting of 23 patients with osteopenia and 9 with osteoporosis, and the overall cohort (N = 134). Pain severity was assessed using the Visual Analog Scale (VAS) at baseline and at the 4-6-week post-procedure follow-up visit, and functional improvement was determined based on patient-reported outcomes at the same time point. Post-procedure complications, including vertebral compression fractures, were monitored until the most recent available follow-up.
A significant decrease in VAS was observed for the overall cohort (7.04 vs. 3.78, p < 0.001) and the Reduced Bone Density group (6.75 vs. 4.13, p < 0.001). Functional improvement was reported by 79.1 % of patients in the overall study population and 78.1 % of patients in the Reduced Bone Density group. No post-procedure vertebral compression fractures were observed in the entire cohort, with a mean follow-up length of 18.07 months.
The Intracept procedure demonstrated significant pain reduction and functional improvement in the overall cohort and in patients with reduced bone density. Notably, no post-procedure vertebral compression fractures were observed, even in patients with osteoporosis and osteopenia. These findings contribute to the growing body of independent literature supporting the safety and effectiveness of the Intracept procedure and offer real-world insight into its use in patients with reduced bone density.
Intracept手术是美国食品药品监督管理局(FDA)批准的首个用于椎基神经消融的技术,这是一种治疗脊椎源性慢性下腰痛的微创治疗方法。虽然先前的研究支持其有效性,但骨质疏松症和骨质减少症患者的数据仍然有限。
评估椎基神经消融的安全性和有效性,特别关注疼痛减轻、功能改善以及术后椎体压缩骨折的发生率。
对2019年11月至2025年1月在本机构接受Intracept手术的患者进行回顾性病历审查。使用现有的双能X线吸收法(DEXA)扫描对骨密度状况进行分类。患者被分为骨密度降低组(N = 32),其中包括23例骨质减少症患者和9例骨质疏松症患者,以及整个队列(N = 134)。在基线时和术后4-6周的随访中使用视觉模拟量表(VAS)评估疼痛严重程度,并在同一时间点根据患者报告的结果确定功能改善情况。监测术后并发症,包括椎体压缩骨折,直至最近一次可用的随访。
整个队列(7.04对3.78,p < 0.001)和骨密度降低组(6.75对4.13,p < (此处原文似乎有误,推测为p < 0.001))的VAS均显著降低。在整个研究人群中,79.1%的患者报告功能得到改善;在骨密度降低组中,这一比例为78.1%。整个队列中未观察到术后椎体压缩骨折,平均随访时间为18.07个月。
Intracept手术在整个队列以及骨密度降低的患者中均显示出显著的疼痛减轻和功能改善。值得注意的是,即使在骨质疏松症和骨质减少症患者中,也未观察到术后椎体压缩骨折。这些发现为支持Intracept手术安全性和有效性的独立文献增添了内容,并为其在骨密度降低患者中的应用提供了实际见解。