Intraosseous basivertebral nerve ablation: Pooled long-term outcomes from two prospective clinical trials

Abstract

BackgroundVertebrogenic pain is an established source of anterior column chronic low back pain (CLBP) resulting from damaged vertebral endplates with pain signals transmitted by the basivertebral nerve (BVN). Type 1 or Type 2 Modic changes on magnetic resonance imaging (MRI) are objective biomarkers for vertebrogenic pain. Radiofrequency ablation of the BVN (BVNA) has demonstrated both efficacy and effectiveness for the treatment of vertebrogenic pain in two randomized trials. Here, we report 3-year aggregate results from two prospective studies of BVNA-treated patients. MethodsPooled results at 3 years post-BVNA are reported for two studies with similar inclusion/exclusion criteria and outcomes measurements: 1) a prospective, open label, single-arm follow-up of the treatment arm of a randomized controlled trial (RCT) comparing BVNA to standard care (INTRACEPT Trial), and 2) a prospective, open label, single cohort long-term follow-up study of BVNA-treated patients. Paired datasets (baseline and 3-years) for mean changes in Oswestry disability index (ODI) and numeric pain scores (NPS) were analyzed using a two-sided t-test with a 0.05 level of significance. ResultsThere were 95/113 (84%) BVNA patients who completed a 3-year visit across 22 study sites. At baseline, 71% of patients reported back pain for ≥5 years, 28% were taking opioids, 34% had spinal injections in the prior 12 months, and 14% had prior low back surgery. Pain and functional improvements were significant at 3 years with a mean reduction in NPS of 4.3 points from 6.7 ​at baseline (95% CI 3.8, 4.8; p<0.0001) and a mean reduction in ODI of 31.2 points from 46.1 ​at baseline (95% CI 28.4, 34.0; p<0.0001). Responder rates, using minimal clinically important differences of ≥15-points for ODI and ≥50% reduction in NPS from baseline to three years, were 85.3% and 72.6%, respectively (combined response 69.5%), with 26.3% of patients reporting 100% pain relief at 3 years. There was a 74% reduction in the use of opioids and 84% reduction in the use of therapeutic spinal interventions from baseline to 3 years. There were no serious device or device-procedure related adverse events reported through three years. ConclusionIntraosseous BVNA demonstrates statistically significant, clinically meaningful, and durable improvements in pain and function through 3 years in patients with primary vertebrogenic low back pain. BVNA-treated patients significantly reduced opioid use and interventions for low back pain.