Intraosseous basivertebral nerve ablation for the treatment of chronic
low back pain: a prospective randomized double-blind sham-controlled
multi-center study
Dokumenttyp:
Article
Autor(en):
Fischgrund, Jeffrey S.; Rhyne, A.; Franke, J.; Sasso, R.; Kitchel, S.; Bae, H.; Yeung, C.; Truumees, E.; Schaufele, M.; Yuan, P.; Vajkoczy, P.; DePalma, M.; Anderson, D. G.; Thibodeau, L.; Meyer, B.
Abstract:
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.
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.
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 ae 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.
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.
[GRAPHICS]
.
Login
BibTeX