03:00 PM Abstract No. 199 Two-year outcomes of patients treated with BVN ablation for the relief of chronic low back pain: results of the SMART trial

Abstract

Thirty percent of Americans have low back pain (LBP) at any given time, leading to approximately 50 million physician visits in the U.S. annually. Chronic low back pain (CLBP) can be difficult to diagnose and treat using either non-surgical therapies or surgical interventions. Antonacci et al. proposed that some pain previously ascribed to the disc actually emanates from the vertebral endplate nociceptors which communicate to the CNS through the basivertebral nerve (BVN).1 The purpose of the present study is to report the 2-year clinical outcomes for CLBP patients treated with radiofrequency (RF) ablation of the BVN in a randomized controlled trial (RCT) that previously reported 1-year follow-up. A total of 147 patients were treated with RF Ablation of the BVN in an RCT designed to demonstrate safety and efficacy as part of a Food and Drug Administration-Investigational Device Exemption (FDA-IDE) trial. Evaluations, including patient self-assessments, physical and neurological examinations, and safety assessments, were performed at two and six weeks, and three, six, twelve, eighteen, and twenty-four months postoperatively. Clinical improvements in ODI, VAS, and SF-36 PCS were statistically significant compared to baseline at all follow-up time points through 2 years. The mean percent improvements in ODI and VAS compared to baseline at 2 years were 53.7% and 52.9%, respectively. Responder rates for ODI and VAS were also maintained through 2 years with patients showing clinically meaningful improvements in both: ODI ≥ 10-point improvement in 76.4% of patients and ODI ≥ 20-point improvement in 57.5%; VAS ≥ 1.5 cm improvement in 70.2% of patients. Patients treated with RF ablation of the BVN for CLBP exhibited sustained clinical benefits in ODI and VAS and maintained high responder rates at 2 years following treatment. BVN ablation appears to be a durable, minimally invasive treatment for the relief of CLBP.