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.

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

objectivesTo evaluate the effectiveness of BVNA for vLBP in a real-world population.

methodsA single-arm prospective cohort study of patients with LBP ≥ 6 months and Type 1 or Type 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.

resultsIn total, 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. Twelve-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). Moreover, 54.7% (95% CI, 41.5-67.3) of participants reported being "much or very much improved" on the PGIC at 12 months. DISCUSSION/

conclusionIn this real-world cohort, over half of participants with vLBP experienced clinically meaningful improvements in pain and function at 12-month post-BVNA. TRIAL REGISTRATION DETAILS: ClinicalTrials.gov (original study: NCT04449835; continuation study: NCT05660512); [original study: June 25, 2020; continuation study: December 13, 2022].