Nagy A Mekhail, Robert M Levy, Timothy R Deer, Leonardo Kapural, Sean Li, Kasra Amirdelfan, Jason E Pope, Corey W Hunter, Steven M Rosen, Shrif J Costandi, Steven M Falowski, Abram H Burgher, Christopher A Gilmore, Farooq A Qureshi, Peter S Staats, James Scowcroft, Tory McJunkin, Jonathan Carlson, Christopher K Kim, Michael I Yang, Thomas Stauss, Erika A Petersen, Jonathan M Hagedorn, Richard Rauck, Jan W Kallewaard, Ganesan Baranidharan, Rod S Taylor, Lawrence Poree, Dan Brounstein, Rui V Duarte, Gerrit E Gmel, Robert Gorman, Ian Gould, Erin Hanson, Dean M Karantonis, Abeer Khurram, Angela Leitner, Dave Mugan, Milan Obradovic, Zhonghua Ouyang, John Parker, Peter Single, Nicole Soliday
INTRODUCTION: The evidence for spinal cord stimulation (SCS) has been criticized for the absence of blinded, parallel randomized controlled trials (RCTs) and limited evaluations of the long-term effects of SCS in RCTs. The aim of this study was to determine whether evoked compound action potential (ECAP)-controlled, closed-loop SCS (CL-SCS) is associated with better outcomes when compared with fixed-output, open-loop SCS (OL-SCS) 36 months following implant. METHODS: The EVOKE study was a multicenter, participant-blinded, investigator-blinded, and outcome assessor-blinded, randomized, controlled, parallel-arm clinical trial that compared ECAP-controlled CL-SCS with fixed-output OL-SCS...
August 27, 2023: Regional Anesthesia and Pain Medicine