The Effectiveness of Basivertebral Nerve Radiofrequency Ablation for the Treatment of Vertebrogenic Low Back Pain: 1-Year Results of a Prospective Real-World Cohort Study.

Abstract

Summary of background data: Multiple clinical trials have demonstrated the effectiveness of intraosseous basivertebral nerve radiofrequency ablation (BVNA) for treating vertebrogenic chronic low back pain (vLBP). Few studies have evaluated the effectiveness in a real-world population.

Objectives: Evaluate the effectiveness of BVNA for vLBP in a real-world population.

Methods: Single-arm prospective cohort study of patients with LBP ≥6 months and Type 1 or 2 Modic changes on MRI. The primary outcome was mean improvement in Oswestry Disability Index (ODI) post-BVNA. Secondary outcomes included the proportion of participants with (1) ≥30% and ≥15-point ODI improvements, (2) ≥2-point and ≥50% reductions in pain on Numerical Rating Scale (NRS), and (3) ≥ "much improved" on Patient Global Impression of Change (PGIC) at 3- and 12-month follow-up.

Results: 60 participants were included (mean age 57.0 ± 13.4 years; 45.0% female). Mean ODI score improvement was 13.9 ± 18.7 and 14.0 ± 15.7 points at 3- and 12-month follow-up, respectively. At 12-months, 52.8% (95%CI: 39.7-65.6) of participants reported ≥30% ODI improvement, and 39.6% (95%CI: 27.6-53.1) of participants reported ≥15-point improvement in ODI. 12-month responder rates for ≥2-point and ≥50% NRS improvement were 67.9% (95%CI: 54.5-78.9) and 49.1% (95%CI: 36.1-62.1). 54.7% (95%CI: 41.5-67.3) of participants reported being "much or very much improved" on the PGIC at 12 months.

Discussion/conclusion: In this real-world cohort, over half of participants with vLBP experienced clinically meaningful improvements in pain and function at 12-months post-BVNA.