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A Prospective, Randomized, Multi-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 12 Month Results

Kevin F. Barrette, MD (University of California San Francisco, San Francisco, California); Matthew Smuck, MD; Steven R. Garfin, MD; Jad Khalil, MD, FAOA

Meeting: AAPM&R Annual Assembly 2020

Categories: Pain and Spine Medicine (2020)

Session Information

Date: Sunday, November 15, 2020

Session Title: Live Poster Session: Pain and Spine Medicine

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 May 9, 2025.
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