Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study

Eur Spine J. 2018 May;27(5):1146-1156. doi: 10.1007/s00586-018-5496-1. Epub 2018 Feb 8.


Purpose: To evaluate the safety and efficacy of radiofrequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of chronic low back pain (CLBP) in a Food and Drug Administration approved Investigational Device Exemption trial. The BVN has been shown to innervate endplate nociceptors which are thought to be a source of CLBP.

Methods: A total of 225 patients diagnosed with CLBP were randomized to either a sham (78 patients) or treatment (147 patients) intervention. The mean age within the study was 47 years (range 25-69) and the mean baseline ODI was 42. All patients had Type I or Type II Modic changes of the treated vertebral bodies. Patients were evaluated preoperatively, and at 2 weeks, 6 weeks and 3, 6 and 12 months postoperatively. The primary endpoint was the comparative change in ODI from baseline to 3 months.

Results: At 3 months, the average ODI in the treatment arm decreased 20.5 points, as compared to a 15.2 point decrease in the sham arm (p = 0.019, per-protocol population). A responder analysis based on ODI decrease ≥ 10 points showed that 75.6% of patients in the treatment arm as compared to 55.3% in the sham control arm exhibited a clinically meaningful improvement at 3 months.

Conclusion: Patients treated with RF ablation of the BVN for CLBP exhibited significantly greater improvement in ODI at 3 months and a higher responder rate than sham treated controls. BVN ablation represents a potential minimally invasive treatment for the relief of chronic low back pain. These slides can be retrieved under Electronic Supplementary Material.

Keywords: Basivertebral nerve; Chronic low back pain; Degenerative disc disease; IDE trial; Radiofrequency ablation; Randomized controlled study; Sham controlled.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Catheter Ablation / methods*
  • Chronic Pain / physiopathology
  • Chronic Pain / surgery*
  • Double-Blind Method
  • Humans
  • Low Back Pain / physiopathology
  • Low Back Pain / surgery*
  • Middle Aged
  • Pain Measurement
  • Prospective Studies
  • Spine* / innervation
  • Spine* / physiopathology
  • Spine* / surgery
  • Treatment Outcome