Intraosseous basivertebral nerve ablation: A 5-year pooled analysis from three prospective clinical trials

• Published in: Interventional Pain Medicine (Online) 2024-12, Vol.3 (4), p.100529, Article 100529
• Main Authors: Khalil, Jad G., Truumees, Eeric, Macadaeg, Kevin, Nguyen, Daniel T.D., Moore, Gregory A., Lukes, Dylan, Fischgrund, Jeffrey
• Format: Article
• Language: English
• Subjects: Basivertebral nerve; Chronic low back pain; Intraosseous radiofrequency ablation; Modic changes; Original; Vertebrogenic pain
• ISSN: 2772-5944; 2772-5944
• DOI: 10.1016/j.inpm.2024.100529

Vertebrogenic pain is a documented source of anterior column chronic low back pain (CLBP) that stems from damaged vertebral endplates. Nociceptive signals are transmitted by the basivertebral nerve (BVN) and endplate damage is observed as Type 1 or Type 2 Modic changes (MC) on magnetic resonance imaging (MRI). The clinical impact and safety of intraosseous radiofrequency ablation of the BVN (BVNA) for the treatment of vertebrogenic pain has been demonstrated in three prospective clinical trials (two randomized and one single-arm study). Report aggregate long-term BVNA outcomes at five years from three studies. Pooled results at 5-years post-BVNA are reported for three clinical trials 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 sham ablation (SMART); 2) a prospective, open label, single-arm follow-up of the treatment arm of an RCT comparing BVNA to standard care (INTRACEPT); and 3) a prospective, open label, single-arm long-term follow-up study of BVNA-treated participants (CLBP Single-Arm). Paired datasets (baseline and 5-years) for mean changes in Oswestry disability index (ODI) and numeric pain scores (NPS) were analyzed using a two-sided paired t-test with a 0.05 level of significance. Secondary outcomes included responder rates, patient satisfaction, adverse events, and healthcare utilization. Two hundred forty-nine (249) of 320 BVNA-treated participants (78 % participation rate) completed a five-year visit (mean of 5.6 years follow-up). At baseline, 71.9 % of these participants reported back pain for ≥5 years, 27.7 % were taking opioids, and 61.8 % had prior therapeutic lumbar spinal injections. Pain and functional improvements were significant at 5-years with a mean improvement in NPS of 4.32 ± 2.45 points (95 % CI 4.01, 4.63; p