{
  "abstract": "Background The efficacy of EVOKE therapy, a closed-loop spinal cord stimulation (SCS) system, has been demonstrated in a double-blinded randomized controlled trial (RCT). RCT evidence, however, may not be generalizable to clinical practice, while limitations of real-world evidence may affect its validity. The aim of this study was to evaluate the effectiveness of EVOKE therapy in routine clinical practice employing a rigorous data collection approach.Methods The ECAP study was a prospective, multicenter, single-arm, pragmatic study that enrolled SCS candidates with chronic, intractable trunk and/or limb pain in 22 US investigational sites. PROMIS-29 questionnaire and objective neurophysiological metrics were collected, and minimal clinically important differences (MCIDs) were used to characterize baseline dysfunction and response to EVOKE therapy both at trial end and maximal analgesic effect post-implant visit. Pre-specified subgroup analyses were conducted based on diagnosis.Results EVOKE therapy observed included a dose ratio of 1.3 and neural dose accuracy of 2.8 μV. Improvements of >1 MCID were observed for all domains and improvements of ≥2 MCIDs were observed for six of the seven domains. Improvements observed at trial end were maintained or improved at post-implant visit, with statistically significant improvement in holistic MCID (MD 0.2, 95% CI 0.1 to 0.4, p=0.004), and a significantly greater proportion of patients considered holistic MCID responders (p=0.047). Subgroup analysis by diagnosis showed similar outcomes.Conclusions EVOKE therapy was associated with clinically meaningful improvements in a real-world chronic pain population across different subgroups and disease pathologies, with effects observed at trial end reproduced at post-implant visit.",
  "authors": [
    {
      "affiliations": [
        "Evolve Restorative Center, Santa Rosa, California, USA"
      ],
      "name": "Jason E Pope"
    },
    {
      "affiliations": [
        "Department of Anesthesiology and Pain Medicine, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA"
      ],
      "name": "Gregory L Smith"
    },
    {
      "affiliations": [
        "Department of Anesthesiology and Pain Medicine, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA"
      ],
      "name": "Johnathan A Goree"
    },
    {
      "affiliations": [
        "Department of Pain Management, Cleveland Clinic, Cleveland, Ohio, USA"
      ],
      "name": "Nagy A Mekhail"
    },
    {
      "affiliations": [
        "International Neuromodulation Society, San Francisco, California, USA"
      ],
      "name": "Robert M Levy"
    },
    {
      "affiliations": [
        "The Spine and Nerve Center of the Virginias, Charleston, West Virginia, USA"
      ],
      "name": "Timothy R Deer"
    },
    {
      "affiliations": [
        "Evolve Restorative Center, Santa Rosa, California, USA"
      ],
      "name": "Chau M Vu"
    },
    {
      "affiliations": [
        "Department of Anesthesiology and Pain Medicine, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA"
      ],
      "name": "Jarna Shah"
    },
    {
      "affiliations": [
        "Department of Pain Management, Cleveland Clinic, Cleveland, Ohio, USA"
      ],
      "name": "Shrif J Costandi"
    },
    {
      "affiliations": [
        "Delaware Valley Pain and Spine Institute, Trevose, Pennsylvania, USA"
      ],
      "name": "Steven M Rosen"
    },
    {
      "affiliations": [
        "Delaware Valley Pain and Spine Institute, Trevose, Pennsylvania, USA"
      ],
      "name": "Todd A Bromberg"
    },
    {
      "affiliations": [
        "Delaware Valley Pain and Spine Institute, Trevose, Pennsylvania, USA"
      ],
      "name": "Atish Patel"
    },
    {
      "affiliations": [
        "Department of Anesthesiology, The University of Kansas School of Medicine, Kansas City, Kansas, USA"
      ],
      "name": "Dawood Sayed"
    },
    {
      "affiliations": [
        "Department of Anesthesiology, The University of Kansas School of Medicine, Kansas City, Kansas, USA"
      ],
      "name": "Christopher M Lam"
    },
    {
      "affiliations": [
        "Department of Anesthesiology, The University of Kansas School of Medicine, Kansas City, Kansas, USA"
      ],
      "name": "Usman Latif"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Duke University Medical Center, Durham, North Carolina, USA"
      ],
      "name": "Shivanand P Lad"
    },
    {
      "affiliations": [
        "Axis Spine Center, Coeur d’Alene, Idaho, USA"
      ],
      "name": "Jessica B Jameson"
    },
    {
      "affiliations": [
        "Clinical Research, Precision Spine Care, Tyler, Texas, USA"
      ],
      "name": "Aaron K Calodney"
    },
    {
      "affiliations": [
        "Neurosurgical Associates of Lancaster, Lancaster, Pennsylvania, USA"
      ],
      "name": "Steven M Falowski"
    },
    {
      "affiliations": [
        "Neurosurgical Associates of Lancaster, Lancaster, Pennsylvania, USA"
      ],
      "name": "Jack Smith"
    },
    {
      "affiliations": [
        "Division of Pain Medicine, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA"
      ],
      "name": "Salim M Hayek"
    },
    {
      "affiliations": [
        "Interventional Pain Management Department, Ochsner Health System, New Orleans, Louisiana, USA"
      ],
      "name": "Maged Guirguis"
    },
    {
      "affiliations": [
        "iSpine Clinics, Maple Grove, Minnesota, USA"
      ],
      "name": "Ronald B Boeding"
    },
    {
      "affiliations": [
        "Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, Minnesota, USA"
      ],
      "name": "Jonathan M Hagedorn"
    },
    {
      "affiliations": [
        "Ethos Behavioral Health Group, Houston, Texas, USA"
      ],
      "name": "Michael Sprintz"
    },
    {
      "affiliations": [
        "The Orthopaedic Institute, Gainesville, FL, Florida, USA"
      ],
      "name": "Ajay Antony"
    },
    {
      "affiliations": [
        "Nevada Advanced Pain Specialists, Reno, Nevada, USA"
      ],
      "name": "Denis Patterson"
    },
    {
      "affiliations": [
        "Spinal Diagnostics, Tualatin, Oregon, USA"
      ],
      "name": "Robert D Heros"
    },
    {
      "affiliations": [
        "Albany Medical Center, Albany, New York, USA"
      ],
      "name": "Andras Laufer"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, University of Arizona College of Medicine, Tucson, Arizona, USA"
      ],
      "name": "Julie G Pilitsis"
    },
    {
      "affiliations": [
        "Coastal Pain & Spinal Diagnostics Medical Group, Carlsbad, California, USA"
      ],
      "name": "Nathan Miller"
    },
    {
      "affiliations": [
        "Alliance Spine and Pain Centers, Atlanta, Georgia, USA"
      ],
      "name": "David Rosenfeld"
    },
    {
      "affiliations": [
        "Southern Pain and Spine, Jasper, Georgia, USA"
      ],
      "name": "Jordan L Tate"
    },
    {
      "affiliations": [
        "Department of Neurological Surgery, Oregon Health & Science University, Portland, Oregon, USA"
      ],
      "name": "Ahmed M Raslan"
    },
    {
      "affiliations": [
        "Department of Anaesthesiology and Pain Management, Rijnstate Hospital, Arnhem, Netherlands",
        "Department of Anesthesiology and Pain Medicine, Amsterdam University Medical Centres, Amsterdam, Netherlands"
      ],
      "name": "Jan Willem Kallewaard"
    },
    {
      "affiliations": [
        "Saluda Medical Pty Ltd, Macquarie Park, New South Wales, Australia"
      ],
      "name": "Angela Leitner"
    },
    {
      "affiliations": [
        "Saluda Medical Pty Ltd, Macquarie Park, New South Wales, Australia"
      ],
      "name": "Erin Hanson"
    },
    {
      "affiliations": [
        "Saluda Medical Pty Ltd, Macquarie Park, New South Wales, Australia"
      ],
      "name": "Nicole Soliday"
    },
    {
      "affiliations": [
        "Saluda Medical Pty Ltd, Macquarie Park, New South Wales, Australia",
        "Department of Health Data Science, University of Liverpool, Liverpool, UK",
        "Center for Pain Medicine, Erasmus University Medical Center, Rotterdam, Netherlands"
      ],
      "name": "Rui V Duarte"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA"
      ],
      "name": "Erika A Petersen"
    }
  ],
  "title": "Clinical utility of ECAP dosing in a real-world population delivered via EVOKE therapy: the ECAP study",
  "uid": "945b1cd2-040c-5d42-8fe8-c2c1b1de77c1"
}