TY - JOUR T1 - Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results JF - Regional Anesthesia & Pain Medicine JO - Reg Anesth Pain Med SP - 683 LP - 693 DO - 10.1136/rapm-2020-102259 VL - 46 IS - 8 AU - Matthew Smuck AU - Jad Khalil AU - Kevin Barrette AU - Joshua Adam Hirsch AU - Scott Kreiner AU - Theodore Koreckij AU - Steven Garfin AU - Nagy Mekhail A2 - , Y1 - 2021/08/01 UR - http://rapm.bmj.com/content/46/8/683.abstract N2 - Introduction Vertebral endplates, innervated by the basivertebral nerve (BVN), are a source of chronic low back pain correlated with Modic changes. A randomized trial comparing BVN ablation to standard care (SC) recently reported results of an interim analysis. Here, we report the results of the full randomized trial, including the 3-month and 6-month between-arm comparisons, 12-month treatment arm results, and 6-month outcomes of BVN ablation in the former SC arm.Methods Prospective, open label, 1:1 randomized controlled trial of BVN ablation versus SC in 23 US sites with follow-up at 6 weeks, 3, 6, 9, and 12 months. SC patients were re-baselined and followed up for 6 months post BVN ablation. The primary endpoint was the between-arm comparison of mean Oswestry Disability Index (ODI) change from baseline. Secondary endpoints were Visual Analog Scale (VAS), Short Form (SF-36), EuroQual Group 5 Dimension 5-Level Quality of Life (EQ-5D-5L), responder rates, and rates of continued opioid use.Results 140 were randomized. Results from BVN ablation (n=66) were superior to SC (n=74) at 3 months for the primary endpoint (mean ODI reduction, difference between arms of −20.3 (CI −25.9 to −14.7 points; p<0.001)), VAS pain improvement (difference of −2.5 cm between arms (CI −3.37 to −1.64, p<0.001)) and quality of life outcomes. At 12 months, basivertebral ablation demonstrated a 25.7±18.5 point reduction in mean ODI (p<0.001), and a 3.8±2.7 cm VAS reduction (p<0.001) from baseline, with 64% demonstrating ≥50% reduction and 29% pain free. Similarly, the former SC patients who elected BVN ablation (92%) demonstrated a 25.9±15.5 point mean ODI reduction (p<0.001) from baseline. The proportion of opioid use did not change in either group (p=0.56).Discussion/Conclusion BVN ablation demonstrates significant improvements in pain and function over SC, with treatment results sustained through 12 months in patients with chronic low back pain of vertebrogenic origin.Data are available on reasonable request. Requests for study protocol and deidentified data access should be forwarded to VP Clinical Affairs, Relievant Medsystems at dsahr@relievant.com. ER -