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Durability of Clinical and Quality-of-Life Outcomes of Closed-Loop Spinal Cord Stimulation for Chronic Back and Leg Pain: A Secondary Analysis of the Evoke Randomized Clinical Trial by Nagy Mekhail; Robert M. Levy; Timothy R. Deer; Leonardo Kapural; Sean Li; Kasra Amirdelfan; Corey W. Hunter; Steven M. Rosen; Shrif J. Costandi; Steven M. Falowski; Abram H. Burgher; Jason E. Pope; Christopher A. Gilmore; Farooq A. Qureshi; Peter S. Staats; James Scowcroft; Tory McJunkin; Jonathan Carlson; Christopher K. Kim; Michael I. Yang; Thomas Stauss; Julie Pilitsis; Lawrence Poree; Dan Brounstein; Samuel Gilbert; 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 is a Medicine article available to read on EtoBox.

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## Importance: Chronic pain is debilitating and profoundly affects health-related quality of life. spinal cord stimulation (scs) is a well-established therapy for chronic pain; however, scs has been limited by the inability to directly measure the elicited neural response, precluding confirmation of neural activation and continuous therapy. a novel scs system measures the evoked compound action potentials (ecaps) to produce a real-time physiological closed-loop control system. ## Objective: To determine whether ecap-controlled, closed-loop scs is associated with better outcomes compared with fixed-output, open-loop scs at 24 months following implant. ## Design, setting, and participants: The evoke study was a double-blind, randomized, controlled, parallel arm clinical trial with 36 months of follow-up. participants were enrolled from february 2017 to 2018, and the study was conducted at 13 us investigation sites. scs candidates with chronic, intractable back and leg pain refractory to conservative therapy, who consented, were screened. key eligibility criteria included overall, back, and leg pain visual analog scale score of 60 mm or more; oswestry disability index score of 41 to 8

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Author

Nagy Mekhail; Robert M. Levy; Timothy R. Deer; Leonardo Kapural; Sean Li; Kasra Amirdelfan; Corey W. Hunter; Steven M. Rosen; Shrif J. Costandi; Steven M. Falowski; Abram H. Burgher; Jason E. Pope; Christopher A. Gilmore; Farooq A. Qureshi; Peter S. Staats; James Scowcroft; Tory McJunkin; Jonathan Carlson; Christopher K. Kim; Michael I. Yang; Thomas Stauss; Julie Pilitsis; Lawrence Poree; Dan Brounstein; Samuel Gilbert; 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

Published

2022

Language

EN

Field

Medicine (Health Sciences)