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

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.