Prospective cohort study of basivertebral nerve ablation for chronic low back pain in a real-world setting: 12 months follow-up

William Schnapp; Moacir Schnapp; Jonathan Gottlieb; Lucien C Alexandre; Kenneth Martiatu; Gaëtan J-R Delcroix

doi:10.1016/j.inpm.2024.100446

Prospective cohort study of basivertebral nerve ablation for chronic low back pain in a real-world setting: 12 months follow-up

Interv Pain Med. 2024 Nov 25;3(4):100446. doi: 10.1016/j.inpm.2024.100446. eCollection 2024 Dec.

Authors

William Schnapp¹, Moacir Schnapp¹, Jonathan Gottlieb^{1

2}, Lucien C Alexandre^{1

2}, Kenneth Martiatu¹, Gaëtan J-R Delcroix^{3

4}

Affiliations

¹ NeuroSpine & Pain Center, Key West, FL, USA.
² Minimally Invasive Spine Center of South Florida, Miami, FL, USA.
³ Nova Southeastern University, College of Allopathic Medicine, Fort Lauderdale, FL, USA.
⁴ Neuroscience Associates, Key West, FL, USA.

Abstract

Background: 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.

Objectives: 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.

Study design: Single group prospective cohort study (ClinicalTrials.gov NCT05692440).

Setting: Single-center, community private practice.

Methods: 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.

Results: 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: Limitations of the study include the lack of a control group and potentially unintentional bias in patient selection.

Conclusions: 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.

Keywords: Basivertebral nerve ablation; Chronic low back pain; Community setting; Endplate degeneration; Independent study; Modic changes; Radiofrequency.

Associated data

ClinicalTrials.gov/NCT05692440