1. ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial.
- Author
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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, and Soliday, Nicole
- Subjects
CHRONIC PAIN ,Neuromodulation ,Spinal Cord Stimulation ,Humans ,Male ,Female ,Spinal Cord Stimulation ,Middle Aged ,Chronic Pain ,Treatment Outcome ,Adult ,Aged ,Single-Blind Method ,Pain Measurement ,Time Factors ,Action Potentials ,Quality of Life - 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
- Published
- 2024