A prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain.
The Spine Journal : Official Journal of the North American Spine Society
BACKGROUND CONTEXT: Current literature suggests that degenerated or damaged vertebral endplates are a significant cause of chronic low back pain (LBP) that is not adequately addressed by standard care. Prior 2-year data from the treatment arm of a sham-controlled randomized controlled trial (RCT) showed maintenance of clinical improvements at 2 years following radiofrequency (RF) ablation of the basivertebral nerve (BVN).
PURPOSE: The purpose of this RCT was to compare the effectiveness of intraosseous RF ablation of the BVN to standard care for the treatment of chronic LBP in a specific subgroup of patients suspected to have vertebrogenic related symptomatology.
STUDY DESIGN/SETTING: A prospective, parallel, open label RCT was conducted at 20 U.S. sites.
PATIENT SAMPLE: A total of 140 patients with chronic LBP of at least 6 months duration, with Modic Type 1 or 2 vertebral endplate changes between L3 and S1, were randomized 1:1 to undergo either RF ablation of the BVN or continue standard care.
OUTCOME MEASURES: Oswestry Disability Index (ODI) was collected at baseline, 3, 6, 9, and 12-months postprocedure. Secondary outcome measures included a 10-point Visual Analog Scale (VAS) for LBP, ODI and VAS responder rates, SF-36, and EQ-5D-5L. The primary endpoint was a between-arm comparison of the mean change in ODI from baseline to 3 months post-treatment.
METHODS: Patients were randomized 1:1 to receive RF ablation or to continue standard care. Self-reported patient outcomes were collected using validated questionnaires at each study visit. An interim analysis to assess for superiority was prespecified and overseen by an independent data management committee when a minimum of 60% of patients had completed their 3-month primary endpoint visit.
RESULTS: The interim analysis showed clear statistical superiority (p
CONCLUSIONS: Minimally invasive RF ablation of the BVN led to significant improvement of pain and function at 3-months in patients with chronic vertebrogenic related LBP.
Khalil JG, Smuck M, Koreckij T, Keel J, Beall D, Goodman B, Kalapos P, Nguyen D, Garfin S; INTRACEPT Trial Investigators. A prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. Spine J. 2019 Oct;19(10):1620-1632. doi: 10.1016/j.spinee.2019.05.598. Epub 2019 Jun 20. PMID: 31229663.