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

European spine journal

article

Eeric Truumees¹  Kevin Macadaeg²  Enrique Pena¹  John Arbuckle²  Jonathan Gentile²  Robert Funk²  Devender Singh¹  Sheetal Vinayek² 

[1] Seton Spine and Scoliosis Center, University of Texas;Indiana Spine Group

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

DOI  :  10.1007/s00586-019-05995-2

来源: Springer

【 摘 要 】

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. 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. 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. 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.

【 授权许可】

Unknown