A prospective, single arm study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results

Abstract

Background: The basivertebral nerve (BVN) has been a recently discovered target as a potential source for vertebrogenic chronic low back pain (CLBP). Prior randomized controlled trials have demonstrated safety and efficacy of BVN ablation for vertebrogenic CLBP, but minimal data exists regarding BVN ablation’s clinical effectiveness with broader application outside of strict trial inclusion criteria. Methods: Prospective, single arm, open label effectiveness trial of 48 patients from community spine and pain practices treated with BVN ablation. Inclusion criteria required more than 6 months of CLBP and type 1 or 2 Modic changes on MRI to be enrolled. Patients were followed post procedure for 12 months using ODI, VAS, EQ-5D-5L and SF-36 patient reported outcome metrics.Results: 47 patients successfully received BVN ablation and 45 patients completed 12 months of follow up. Mean reduction in ODI at 12 months was 32.31 +/- 14.07 (p<0.001) with 88.89% (40/45) patients reporting a ≥15 point ODI decrease at 12 months. Mean VAS pain score decrease was 4.31+/-2.51 at 12 months (p<0.001) and more than 69% reported a 50% reduction in VAS pain scale. Similarly, SF-36 and EQ-5D-5L scores improved 26.27+/-17.19 and 0.22+/-0.15 (each p<0.001). Conclusions: This data supports the clinical effectiveness of BVN ablation in the community practice setting, with similar 12 month improvements in patient reported outcomes as seen in previously published randomized control trials.