Session Time: 12:45pm-1:45pm
Disclosures: Kevin F. Barrette, MD: No financial relationships or conflicts of interest
Objective : The vertebral endplates, innervated by the basivertebral nerve (BVN) are a potential source of chronic low back pain (CLBP). In a previous sham-controlled study, BVN radiofrequency ablation demonstrated efficacy and durability up to 24 months in patients with CLBP and endplate changes on MRI (Modic Type I or II). Following this, a new prospective, randomized study was initiated to compare the effectiveness of BVN-ablation to standard care. The study was halted early after the pre-planned interim analysis demonstrated statistical superiority in the BVN-ablation arm. The goal of this study is to evaluate the effectiveness of BVN-ablation in patients suspected to have vertebrogenic CLBP by reporting the results of the entire study cohort from the comparative effectiveness study, including 12-month results in the BVN-ablation arm and 6-month results in the cross-over group.
Design: Randomized, Controlled Trial
Setting : Multiple Academic Spine Centers
Participants : 140 patients were prospectively randomized to receive BVN-ablation or standard care. The latter were offered early cross-over due to results from the pre-planned interim analysis.
Interventions: Intraosseous BVN-ablation.
Main Outcome Measures: Oswestry Disability Index (ODI) and pain Visual Analog Scale (VAS).
Results: In the BVN-ablation arm (n=66) at 12mo significant improvements in function and pain were observed with a mean reduction in ODI of 25.7 (p < 0.001) and VAS of 3.79 (p < 0.001). Of these, 69% reported > 15 point improvement in ODI. Pain reduction was >50% in 64%, >75% in 44%, and 29% reported 100% relief. In the standard care arm (n=74), 8 patients dropped out by cross-over, and 61/66 (92%) elected for BVN-ablation. At 6mo this cross-over group demonstrated a similar mean 25.9-point reduction in ODI (p < 0.001) and -3.84 VAS (p < 0.001) decrease.
Conclusions: BVN-ablation led to significant improvements in pain and function and may be an effective treatment for a subset of patients with CLBP of suspected vertebrogenic origin.
Level of Evidence: Level I
To cite this abstract in AMA style:Barrette KF, Smuck M, Garfin SR, Khalil J. A Prospective, Randomized, Multi-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 12 Month Results [abstract]. PM R. 2020; 12(S1)(suppl 1). https://pmrjabstracts.org/abstract/a-prospective-randomized-multi-center-study-of-intraosseous-basivertebral-nerve-ablation-for-the-treatment-of-chronic-low-back-pain-12-month-results/. Accessed April 16, 2021.
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PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/a-prospective-randomized-multi-center-study-of-intraosseous-basivertebral-nerve-ablation-for-the-treatment-of-chronic-low-back-pain-12-month-results/