Pain Location and Exacerbating Activities Associated with Treatment Success Following Basivertebral Nerve Ablation: An Aggregated Cohort Study of Multicenter Prospective Clinical Trial Data.

" : On behalf of the Vertebrogenic Pain Steering Committee: Zachary McCormick, M.D., Eeric Truumees, M.D., Joshua Hirsch, M.D., Matthew Smuck, M.D., Naggy Mehkail, M.D., Barrett Boody, M.D., and Jeffrey Lotz, M.D.: Funding sources: An investigator-initiated grant was provided by Relievant Medsystems, Inc., to support this study. Zachary L. McCormick, as the PI, designed the study and pain body diagram mapping methods, oversaw the regression model development, had full access to all the data in the study, and takes responsibility for the integrity of the data and the accuracy of the data analysis. The analysis was conducted by an independent biostatistician, Katrina Harper who had full access to the data in the study and takes responsibility for the integrity of the data analysis and statistical reporting.: Disclosures and Conflicts of interest: Zachary L. McCormick has received research funding from Relievant Medsystems Inc, paid directly to the University of Utah. Barrett S. Boody has received research funding from Relievant Medsystems, Inc. Joshua Hirsch, M.D has received funding directly from Relievant Medsystems for consulting, research advisory roles and training. Aaron Conger has received research funding from Relievant Medsystems Inc, paid directly to the University of Utah. Jeffrey C. Lotz, PhD has received royalties from Relievant Medsystems, Inc., and Nocimed/Aclarion paid to the University of California at San Francisco, patents from Relievant Medsystems, Inc., and Nocimed/Aclarion directly to University of California at San Francisco, stock from Relievant Medsystems, Inc., and Nocimed/Aclarion and consulting fees and honoraria from Relievant Medsystems, Inc.: Disclosure: Beau P. Sperry and Taylor Burnham have no disclosures.: Supplement sponsorship: This article appears as part of the supplement entitled “Vertebrogenic Pain and Basivertebral Nerve Radiofrequency Ablation” sponsored by Relievant Medsystems Inc."

" : On behalf of the Vertebrogenic Pain Steering Committee: Zachary McCormick, M.D., Eeric Truumees, M.D., Joshua Hirsch, M.D., Matthew Smuck, M.D., Naggy Mehkail, M.D., Barrett Boody, M.D., and Jeffrey Lotz, M.D.: Funding sources: An investigator-initiated grant was provided by Relievant Medsystems, Inc., to support this study. Zachary L. McCormick, as the PI, designed the study and pain body diagram mapping methods, oversaw the regression model development, had full access to all the data in the study, and takes responsibility for the integrity of the data and the accuracy of the data analysis. The analysis was conducted by an independent biostatistician, Katrina Harper who had full access to the data in the study and takes responsibility for the integrity of the data analysis and statistical reporting.: Disclosures and Conflicts of interest: Zachary L. McCormick has received research funding from Relievant Medsystems Inc, paid directly to the University of Utah. Barrett S. Boody has received research funding from Relievant Medsystems, Inc. Joshua Hirsch, M.D has received funding directly from Relievant Medsystems for consulting, research advisory roles and training. Aaron Conger has received research funding from Relievant Medsystems Inc, paid directly to the University of Utah. Jeffrey C. Lotz, PhD has received royalties from Relievant Medsystems, Inc., and Nocimed/Aclarion paid to the University of California at San Francisco, patents from Relievant Medsystems, Inc., and Nocimed/Aclarion directly to University of California at San Francisco, stock from Relievant Medsystems, Inc., and Nocimed/Aclarion and consulting fees and honoraria from Relievant Medsystems, Inc.: Disclosure: Beau P. Sperry and Taylor Burnham have no disclosures.: Supplement sponsorship: This article appears as part of the supplement entitled “Vertebrogenic Pain and Basivertebral Nerve Radiofrequency Ablation” sponsored by Relievant Medsystems Inc."

"A combined total of 296 patients underwent successful BVN RFA; 290 of these patients completed both an ODI and VAS surveys at three months post-BVN RFA and had a baseline pain body diagram completed. An Institutional Review Board approved each study (Western IRB no. PRO20111346, Schulman IRB no. 201702680/ADVARRA IRB# PRO00026311, and Schulman IRB no. 201706803/Advarra IRB no. Pro000226859, respectively) with informed consent and privacy authorization by study patients. Each study was registered on clinicaltrials.gov (trial registration numbers NCT01446419, NCT03246061, and NCT03266107, respectively). No clinical sites or patients were contacted for this retrospective analysis. All pain body diagrams and data used in this secondary research were deidentified and unable to be traced to an individual participant. As such, no additional IRB review was required for this secondary research."