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

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.