Intraosseous Basivertebral Nerve Ablation: 5-Year Outcomes From Three Long-Term Follow-up Studies

Document Type

Conference Proceeding

Publication Date

2025

Publication Title

Brain and Spine

Abstract

INTRODUCTION: Chronic low back pain (CLBP) treatment has evolved to include specific interventions targeting subtypes of CLBP, such as vertebrogenic pain which is caused by endplate damage or inflammation. The nociceptive signal is transmitted by the basivertebral nerve which is the therapeutic target for vertebrogenic pain. The safety and efficacy of intraosseous basivertebral nerve ablation (BVNA) are demonstrated in clinical trials, independent studies, societal guidelines and meta-analyses. We report 5-year outcomes of BVNA procedures from three long-term follow-up studies in the United States. MATERIALS AND METHODS: Pooled results are reported for: 1) the treatment arm of a prospective multicenter sham-controlled trial of BVNA (SMART) with an optional 5-year follow-up sub-study (SMART5); 2) the treatment arm and elective crossover arm of a prospective open-label 1:1 randomized controlled trial of BVNA versus standard care conducted with an optional long-term surveillance sub-study (INTRACEPT); and 3) A prospective open-label single-arm follow-up study of BVNA-treated patients (CLBP Single-Arm) with an optional long-term follow up sub study (CLBP Long-term). All studies included up to 5-year follow-up. Oswestry disability index (ODI) and numeric pain scores (NPS) were compared to baseline. Secondary outcomes included responder rates, patient satisfaction, and healthcare utilization. RESULTS: Out of 320 patients who received BVNA, 249 (78%) completed a 5- year visit. At baseline, patients reported a mean ODI of 44.5 ± 11.0 and a mean NPS score of 6.8 ± 1.3. The mean age was 48.1 ± 10.3 years and 69% reported having back pain for 5 years. Pain and functional improvements were significant, with a mean reduction in NPS of 4.3 ± 2.5 (p< 0.0001) and in ODI of 28.0 ± 17.5 (p< 0.0001) from baseline. Clinically and statistically significant responder rates of 15-point reduction in ODI and 2-point reduction in NPS pain score were 78.3% (p< 0.0001) and 83.1% (p< 0.0001) respectively. At 5- years post-procedure, 32% of patients reported being pain-free, 73% of patients reported their condition as improved and 69% reported having resumed the activity level they had enjoyed prior to the onset of low back pain. There were no serious device or device-procedure related adverse events, and no new complications or unintended consequences of the procedure. CONCLUSIONS: Long-term follow-up (mean 5.6 years) from three clinical trials demonstrates that post-intraosseous BVNA results in sustained and significant improvements in pain and physical functioning. Results support the strong safety profile of intraosseous BVNA with no adverse events reported in the long-term follow-up study.

Volume

5

Issue

4

First Page

105644

Comments

DWG/German Spine Society Annual Meeting, December 10-12, 2025, Wiesboden, Germany

Last Page

105644

DOI

10.1016/j.bas.2025.105644

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