학술논문
Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results
Document Type
article
Author
Smuck, Matthew; Khalil, Jad; Barrette, Kevin; Hirsch, Joshua Adam; Kreiner, Scott; Koreckij, Theodore; Garfin, Steven; Mekhail, Nagy; Beall, Douglas; Bainbridge, Scott; Kalapos, Paul; Phillips, Frank; Keel, John; Wang, Jeffrey; Munyon, Charles; Markman, John; Vrooman, Bruce; Anand, Neel; Lieberman, Daniel; Shannon, Larry; Calodney, Aaron; Yonemura, Ken; Goodman, Bradly; Moore, Gregory; Schaufele, Michael; Rhyne, Dan Nguyen Al
Source
Regional Anesthesia & Pain Medicine. 46(8)
Subject
Language
Abstract
IntroductionVertebral endplates, innervated by the basivertebral nerve (BVN), are a source of chronic low back pain correlated with Modic changes. A randomized trial comparing BVN ablation to standard care (SC) recently reported results of an interim analysis. Here, we report the results of the full randomized trial, including the 3-month and 6-month between-arm comparisons, 12-month treatment arm results, and 6-month outcomes of BVN ablation in the former SC arm.MethodsProspective, open label, 1:1 randomized controlled trial of BVN ablation versus SC in 23 US sites with follow-up at 6 weeks, 3, 6, 9, and 12 months. SC patients were re-baselined and followed up for 6 months post BVN ablation. The primary endpoint was the between-arm comparison of mean Oswestry Disability Index (ODI) change from baseline. Secondary endpoints were Visual Analog Scale (VAS), Short Form (SF-36), EuroQual Group 5 Dimension 5-Level Quality of Life (EQ-5D-5L), responder rates, and rates of continued opioid use.Results140 were randomized. Results from BVN ablation (n=66) were superior to SC (n=74) at 3 months for the primary endpoint (mean ODI reduction, difference between arms of -20.3 (CI -25.9 to -14.7 points; p