Schnapp William, Schnapp Moacir, Gottlieb Jonathan, Alexandre Lucien C, Martiatu Kenneth, Delcroix Gaëtan J-R
NeuroSpine & Pain Center, Key West, FL, USA.
Minimally Invasive Spine Center of South Florida, Miami, FL, USA.
Interv Pain Med. 2024 Nov 25;3(4):100446. doi: 10.1016/j.inpm.2024.100446. eCollection 2024 Dec.
The basivertebral nerve, which densely supplies the vertebral endplates, is a potential source of chronic low back pain transmission in patients with Modic changes. Basivertebral nerve ablation (BVNA), a minimally invasive procedure, aims to disrupt this pain signaling.
In this study, we investigated BVNA's effectiveness in treatment of vertebrogenic low back pain and we followed patients for 12 months to assess long-term effectiveness.
Single group prospective cohort study (ClinicalTrials.gov NCT05692440).
Single-center, community private practice.
Thirty-five patients were treated with the INTRACEPT® device (Boston Scientific, MA, USA). Thirty-one patients completed Oswestry Disability Index (ODI), Visual Analog Scale (VAS), SF-36 Physical Component Summary (PCS), and SF-36 Mental Component Summary (MCS) at baseline and follow-up visits up to 12 months.
The average age of the 31 patients was 73.0 ± 6.34 years and 71.0 % of the population was male (N=22)) at baseline. All four self-reported outcomes (ODI, VAS, SF-36 PCS, and MCS) showed statistically and clinically significant improvements from baseline through 12 months (all p < 0.001, with the exception of the SF-36 MCS at 1 month, p = 0.165). Overall, 67.7 % of patients demonstrated ODI improvements above the minimal clinically important difference (decrease of at least 15 points) and 77.4 % of patients demonstrated a decrease on the VAS above the minimal clinically important difference (≥2 cm reduction) at 12 months.
Limitations of the study include the lack of a control group and potentially unintentional bias in patient selection.
BVNA demonstrates potential as an effective and minimally invasive treatment for chronic low back pain in a real-world patient cohort where substantial improvements were observed. These results align with those seen in previous randomized controlled trials (RCTs) and industry-funded studies of BVNA.
椎体神经密集地供应椎体终板，是伴有Modic改变的患者慢性下腰痛传导的潜在来源。椎体神经消融术（BVNA）是一种微创手术，旨在中断这种疼痛信号传导。
在本研究中，我们调查了BVNA治疗椎源性下腰痛的有效性，并对患者进行了12个月的随访以评估长期疗效。
单组前瞻性队列研究（ClinicalTrials.gov NCT05692440）。
单中心社区私人诊所。
35例患者接受了INTRACEPT®设备（美国马萨诸塞州波士顿科学公司）治疗。31例患者在基线及长达12个月的随访中完成了奥斯威斯残疾指数（ODI）、视觉模拟量表（VAS）、SF-36身体成分总结（PCS）和SF-36精神成分总结（MCS）评估。
31例患者的平均年龄为73.0±6.34岁，基线时71.0%的患者为男性（N=22）。所有四项自我报告结局（ODI、VAS、SF-36 PCS和MCS）从基线到12个月均显示出统计学和临床意义上的显著改善（所有p<0.001，但1个月时的SF-36 MCS除外，p=0.165）。总体而言，67.7%的患者在12个月时ODI改善超过最小临床重要差异（至少降低15分），77.4%的患者VAS降低超过最小临床重要差异（降低≥2 cm）。
本研究的局限性包括缺乏对照组以及患者选择中可能存在的无意偏倚。
在观察到显著改善的真实世界患者队列中，BVNA显示出作为慢性下腰痛有效且微创治疗方法的潜力。这些结果与先前关于BVNA的随机对照试验（RCT）和行业资助研究的结果一致。
