Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results

Abstract

IntroductionVertebral 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.MethodsProspective, 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.Results140 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/ConclusionBVN 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.

Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results

“…The risk of this minimally invasive procedure remains low, with only one serious device-procedure related event reported in the literature for the 493 clinical study cases (including sham and crossover procedures) for an overall serious deviceprocedure related event rate of 0.2%. [12,14,15,21] The primary non-serious device-procedure related event reported in this study were transient leg and back pain events. Leg pain events were mild in nature, primarily treated with oral medications, and had a median resolution of 48.5 days.…”

“…Likewise, in the 91% of SC arm patients that opted to cross to BVNA, similar results were observed, with reductions of 25.9 points in mean ODI and 3.8 cm in mean VAS from re-baseline at 6 months post ablation. Treatment outcomes for the BVNA remained durable through 12 months [15] . We report 24-month outcomes of the treatment arm for this second RCT and explore the applicability of these results in practice today.…”

“…Treatment outcomes for the BVNA remained durable through 12 months. [15] We report 24-month outcomes of the treatment arm for this second RCT and explore the applicability of these results in practice today.…”

Interventional Procedures for Vertebral Diseases: Spinal Tumor Ablation, Vertebral Augmentation, and Basivertebral Nerve Ablation—A Scoping Review

“…Numerous clinical studies, reviews, meta-analyses, and society guidelines have reported the safety and clinical efficacy of BVNA in the treatment of vertebral pain [42][43][44][45][46][47][48][49][50][51][52][53]115,116,[132][133][134][135][136]. Becker et al's study in 2017 reported that BVNA improved function at 6 weeks, 3, 6, and 12 months, with at least a 10-point reduction in ODI in 81% of subjects, as well as clinically meaningful improvement in pain scores and QoL [53].…”

“…The subsequent data showed only 4% of subjects received spinal injections after BVNA, suggesting that this intervention effectively reduces symptoms and minimizes additional health care costs. Smuck et al reported BVNA superiority to the standard of care (medications, therapy, and spinal injections) at 3-, 6-, and 12-month intervals for improved pain, function and QoL [42]. However, opioid use did not differ between groups.…”