SIR 2024
Pain Management/MSK
Jacob W. Fleming, MD
Fellow, Musculoskeletal IR
Clinical Radiology of Oklahoma
Financial relationships: Full list of relationships is listed on the CME information page.
Douglas Beall, MD, FSIR
Chief of Radiology Services
Comprehensive Specialty Care
Financial relationships: Full list of relationships is listed on the CME information page.
Zachary McCormick, MD (he/him/his)
Vice Chair of PM&R; Chief of Spine and Musculoskeletal Medicine
University of Utah
Financial relationships: Full list of relationships is listed on the CME information page.
The safety and efficacy of intraosseous basivertebral nerve ablation (BVNA) for the treatment of vertebrogenic pain has been demonstrated in two randomized controlled trials, two meta-analyses, and several single-arm studies and systematic reviews. The primary goal of this paper is to report the 4-year aggregate results of two prospective, single-arm, open-label, multi-center studies of patients treated with BVNA.
Materials and Methods:
Four-year aggregate results are reported for: 1) a prospective, open-label, single-arm sub-study of the treatment arm of the randomized controlled trial of basivertebral nerve ablation versus standard care conducted in 20 U.S. sites with follow-up at 3, 6, 9, 12, 24, 36, 48, and 60 months; and 2) a prospective, open-label, single-arm follow-up study of basivertebral nerve ablation-treated patients in two U.S. sites with follow-up at 3, 6, 9, 12, 36, 48, and 60 months. Patient-reported Oswestry disability index (ODI) and numeric pain scores (NPS) at 4 years were compared to baseline using a two-sided paired t-test with a 0.05 level of significance. Secondary outcomes included responder rates and healthcare utilization.
Results:
Ninety-four patients (N=94) received basivertebral nerve ablation and completed a 4-year visit (an 83% participation rate). At baseline, patients reported a mean NPS of 6.7 ± 1.2 and mean ODI of 46.2 ± 10.8, with 70% reporting back pain for ≥ 5 years. Pain and functional improvements were significant at four years with a reduction in mean NPS of 3.9 ± 2.6 points (95% CI 3.4, 4.5; p< 0.0001) and in mean ODI of 30.8 ± 15.9 (95% CI 27.5, 34.0; p< 0.0001) from baseline. Responder rates, using minimal clinically important differences of ≥ 15-points for ODI and ≥ 50% reduction in NPS from baseline, were 80.9% and 61.7%, respectively. 23.4% of patients reported being pain-free at four years. The combined ODI and NPS response rate was 59.6%. At four years there was a 70.4% decrease in the number of patients taking opioids compared to baseline, with only 9.6% of patients actively taking opioids. Only 4.3% of patients had therapeutic injections post-ablation that were adjudicated as treating the same pain etiology per independent physician reviewers. There were no serious device or procedure related adverse events reported through 4 years.
Conclusion: Intraosseous BVNA demonstrates clinically and statistically significant durable improvements in pain and function through four years post-ablation in patients with vertebrogenic chronic low back pain.