Fischgrund, Jeffrey S.Rhyne, AlfredFranke, JörgSasso, RickKitchel, ScottBae, HyunYeung, ChristopherTruumees, EericSchaufele, MichaelYuan, PhilipVajkoczy, PeterDePalma, MichaelAnderson, David G.Thibodeau, LeeMeyer, Bernhard2018-08-102018-08-102019-04-30Fischgrund, J. S., Rhyne, A., Franke, J., Sasso, R., Kitchel, S., Bae, H., … Meyer, B. (2018). Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study. European Spine Journal, 27(5), 1146–1156. https://doi.org/10.1007/s00586-018-5496-10940-6719, 1432-0932https://hdl.handle.net/1805/17084PurposeTo 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.MethodsA 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.ResultsAt 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.ConclusionPatients 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.Graphical abstract These slides can be retrieved under Electronic Supplementary Material. Open image in new windowen-USAttribution 3.0 United StatesChronic low back painDegenerative disc diseaseRadiofrequency ablationBasivertebral nerveSham controlledRandomized controlled studyIDE trialArticle