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

PurposeTo 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 windo

Anatomic mapping and evaluation of the esophagus in relation to the cervical vertebral body

The relationship of the esophagus to the cervical vertebral body (CVB), disc space and longus colli (LC) muscles, to our knowledge, has not been previously studied. The purpose of this study was to quantify the relationship of the esophagus to the CVB, disc space and LC. 30 patients were selected for a retrospective review of computed tomography (CT) scans. Measurements between the esophagus and the C5, C6, and C7 vertebral bodies as well as the C5/6 and C6/7 disc spaces were performed in the midline, 3 mm right and left of midline, and at the edge of the LC on both sides. The closest distance of the esophagus to the CVB and disc space occurs at the midline (range 1.02–1.31 mm at each level). The furthest distance occurred at the edge of the right LC (range 2.67–3.30 mm at each level). The mean distance from the edge of the right LC to the midline was significantly greater (P < 0.01) than mean distance from the edge of the left LC to the midline. No statistical significant differences were observed when comparing measurements at the individual vertebral bodies and disc spaces. The results of the study demonstrate that the esophagus lies in closest proximity to the CVB and disc space in the midline. A larger potential space exists between the esophagus and the CVB and disc space at the edge of the LC. These results may provide insight into a potential cause of post-operative dysphagia. Furthermore, it may help guide the future design of cervical plates to better utilize the potential space between the esophagus and the CVB and disc space at the edge of the LC