Literature DB >> 31115683

A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain.

Eeric Truumees1, Kevin Macadaeg2, Enrique Pena3, John Arbuckle2, Jonathan Gentile2, Robert Funk2, Devender Singh3, Sheetal Vinayek2.   

Abstract

PURPOSE: A prospective, single-arm, open-label study to evaluate the effectiveness of intraosseous radio frequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of vertebrogenic-related chronic low back pain (CLBP) in typical spine practice settings using permissive criteria for study inclusion.
METHODS: Consecutive patients with CLBP of at least 6 months duration and with Modic Type 1 or 2 vertebral endplate changes between L3 and S1 were treated with RF ablation of the BVN in up to four vertebral bodies. The primary endpoint was patient-reported change in Oswestry Disability Index (ODI) from baseline to 3 months post-procedure. Secondary outcome measures included change in visual analog scale (VAS), SF-36, EQ-5D-5L, and responder rates.
RESULTS: Median age was 45 years; baseline ODI was 48.5; VAS was 6.36. Seventy-five percent (75%) of the study patients reported LBP symptoms for ≥ 5 years; 25% were actively using opioids; and 61% were previously treated with injections. Mean change in ODI at 3 months posttreatment was - 30.07 +14.52 points (p < 0.0001); mean change in VAS was - 3.50 + 2.33 (p < 0.0001). Ninety-three percent (93%) of patients achieved a ≥ 10-point improvement in ODI, and 75% reported ≥ 20-point improvement.
CONCLUSIONS: Minimally invasive RF ablation of the BVN demonstrated a significant improvement in pain and function in this population of real-world patients with chronic vertebrogenic-related LBP. These slides can be retrieved under Electronic Supplementary Material.

Entities:  

Keywords:  Basivertebral nerve; Chronic low back pain; Endplate degeneration; Modic; Radiofrequency ablation; Vertebrogenic pain

Year:  2019        PMID: 31115683     DOI: 10.1007/s00586-019-05995-2

Source DB:  PubMed          Journal:  Eur Spine J        ISSN: 0940-6719            Impact factor:   3.134


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6.  A prospective, single arm study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results.

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