Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study

European spine journal

article

Jeffrey S. Fischgrund¹  Alfred Rhyne²  Kevin Macadaeg³  Gregory Moore⁴  Evish Kamrava⁵  Christopher Yeung⁶  Eeric Truumees⁷  Michael Schaufele⁸  Philip Yuan⁹  Michael DePalma^1,10  David Greg Anderson^1,11  Douglas Buxton^1,12  James Reynolds^1,13  Michael Sikorsky^1,14 

[1] William Beaumont Hospital, Oakland University School of Medicine, Royal Oak;OrthoCarolina Spine Center;Indiana Spine Group;Pacific Sports and Spine;The Spine Institute;Desert Institute for Spine Care;Seton Spine & Scoliosis Center;Drug Studies America;Memorial Orthopedic Surgical Group, Department of Surgery, Long Beach Memorial Medical Center;Virginia iSpine Physicians;Rothman Orthopedic Institute;Maine Medical Partners Neurosurgery and Spine, Portland;Spine Care Medical Group;Michigan Orthopedic Institute

关键词: Chronic low back pain;    Basivertebral nerve;    Radiofrequency ablation;    Modic;    Randomized controlled trial;   

DOI  :  10.1007/s00586-020-06448-x

来源: Springer

【 摘 要 】

Damaged or degenerated vertebral endplates are a significant cause of vertebrogenic chronic low back pain (CLBP). Modic changes are one objective MRI biomarker for these patients. Prior data from the treatment arm of a sham-controlled, RCT showed maintenance of clinical improvements at 2 years following ablation of the basivertebral nerve (BVN). This study reports 5-year clinical outcomes. In total, 117 US patients were treated successfully with BVN ablation. Patient-reported outcomes of ODI, VAS, postablation treatments, and patient satisfaction were collected at a minimum of 5-years following BVN ablation. Primary outcome was mean change in ODI. Comparisons between the postablation and baseline values were made using an analysis of covariance with alpha 0.05. Of the 117 US treated patients 100 (85%) were available for review with a mean follow-up of 6.4 years (5.4–7.8 years). Mean ODI score improved from 42.81 to 16.86 at 5-year follow-up, a reduction of 25.95 points (p  50% reduction in pain, 47% reported a > 75% reduction in pain, and 34% of patients reported complete pain resolution. Composite responder rate using thresholds of ≥ 15-point ODI and ≥ 2-point VAS for function and pain at 5 years was 75%. CLBP patients treated with BVN ablation exhibit sustained clinical improvements in function and pain with high responder rates at a mean of 6.4 years following treatment. BVN ablation is a durable, minimally invasive treatment for vertebrogenic CLBP.

【 授权许可】

Unknown