Abstract
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 abstractThese slides can be retrieved under Electronic Supplementary Material.
Highlights
Mechanical back pain arising from degenerative disc disease (DDD) is transmitted through the basivertebral nerve (BVN)2. Patients treated with percutaneous, transpedicular, RF ablation of the BVN reported about one grade decrease in Oswestry Disability Index questionnaire (ODI) and substantial improvement in visual analog scale (VAS)
Low back pain (LBP) is the most common cause of activity limitation in individuals younger than 45 years of age
Fritzell et al found an 11 point decrease in Oswestry Disability Index questionnaire (ODI) in patients fused for chronic low back pain (CLBP), and noted that the improvement in pain gradually deteriorated after 6 months [1]
Summary
2. Patients treated with percutaneous, transpedicular, RF ablation of the BVN reported about one grade decrease in ODI and substantial improvement in VAS. 3. The Intracept procedure represents a new, minimally invasive method of providing relief of chronic low back pain. Keywords Chronic low back pain · Degenerative disc disease · Radiofrequency ablation · Basivertebral nerve · Sham controlled · Randomized controlled study · IDE trial
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