학술논문
ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial.
Document Type
article
Author
Mekhail, Nagy; Levy, Robert; Deer, Timothy; Kapural, Leonardo; Li, Sean; Amirdelfan, Kasra; Pope, Jason; Hunter, Corey; Rosen, Steven; Costandi, Shrif; Falowski, Steven; Burgher, Abram; Gilmore, Christopher; Qureshi, Farooq; Staats, Peter; Scowcroft, James; McJunkin, Tory; Carlson, Jonathan; Kim, Christopher; Yang, Michael; Stauss, Thomas; Petersen, Erika; Hagedorn, Jonathan; Rauck, Richard; Kallewaard, Jan; Baranidharan, Ganesan; Taylor, Rod; Poree, Lawrence; Brounstein, Dan; Duarte, Rui; Gmel, Gerrit; Gorman, Robert; Gould, Ian; Hanson, Erin; Karantonis, Dean; Khurram, Abeer; Leitner, Angela; Mugan, Dave; Obradovic, Milan; Ouyang, Zhonghua; Parker, John; Single, Peter; Soliday, Nicole
Source
Regional anesthesia. 49(5)
Subject
Language
Abstract
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. Participants with chronic, intractable back and leg pain refractory to conservative therapy were enrolled between January 2017 and February 2018, with follow-up through 36 months. The primary outcome was a reduction of at least 50% in overall back and leg pain. Holistic treatment response, a composite outcome including pain intensity, physical and emotional functioning, sleep, and health-related quality of life, and objective neural activation was also assessed. RESULTS: At 36 months, more CL-SCS than OL-SCS participants reported ≥50% reduction (CL-SCS=77.6%, OL-SCS=49.3%; difference: 28.4%, 95% CI 12.8% to 43.9%, p