Evidence map›Paper›PMID 38490687›Full record

Trial reportRegional anesthesia and pain medicine2025

Neurophysiological outcomes that sustained clinically significant improvements over 3 years of physiologic ECAP-controlled closed-loop spinal cord stimulation for the treatment of chronic pain.

Nagy A 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 and 18 more

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Regional anesthesia and pain medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
7.1field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Long-term outcomes of spinal cord stimulation for refractory phantom limb pain.Frontiers in pain research (Lausanne, Switzerland) · 2026
    Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors at 14 institutions in 3 countries.

Nagy A MekhailEvidence-Based Pain Management Research, Cleveland Clinic, Cleveland, Ohio, USA mekhain@ccf.org.ORCID 0000-0002-3823-9610
Robert M LevyAnesthesia Pain Care Consultants, Boca Raton, Florida, USA.
Timothy R DeerSpine and Nerve Center of the Virginias, Charleston, West Virginia, USA.ORCID 0000-0001-8907-7730
Leonardo KapuralCarolinas Pain Institute, Winston-Salem, North Carolina, USA.
Sean LiNational Spine and Pain Centers, Shrewsbury, New Jersey, USA.
Kasra AmirdelfanIntegrated Pain Management Medical Group Inc, Walnut Creek, California, USA.
Corey W HunterAinsworth Institute of Pain Management, New York, New York, USA.
Steven M RosenDelaware Valley Pain and Spine Institute, Trevose, Pennsylvania, USA.
Shrif J CostandiEvidence-Based Pain Management Research, Cleveland Clinic, Cleveland, Ohio, USA.ORCID 0000-0002-0864-9846
Steven M FalowskiArgires-Marotti Neurosurgical Associates of Lancaster, Lancaster, Pennsylvania, USA.
Abram H BurgherHOPE Research Institute, Phoenix, Arizona, USA.
Jason E PopeEvolve Restorative Center, Santa Rosa, California, USA.
Christopher A GilmoreCarolinas Pain Institute, Winston-Salem, North Carolina, USA.
Farooq A QureshiSt Luke's Spine & Pain Associates, Easton, Pennsylvania, USA.
Peter S StaatsNational Spine and Pain Centers, Shrewsbury, New Jersey, USA.
James ScowcroftPain Management Associates, Independence, Missouri, USA.
Tory McJunkinArizona Pain, Glendale, Arizona, USA.
Christopher K KimSpine and Nerve Center of the Virginias, Charleston, West Virginia, USA.
Michael I YangSummit Pain Alliance, Santa Rosa, California, USA.
Thomas StaussPain Physicians of Wisconsin, Milwaukee, Wisconsin, USA.
Richard RauckCarolinas Pain Institute, Winston-Salem, North Carolina, USA.
Rui V DuarteDepartment of Health Data Science, University of Liverpool, Liverpool, UK.ORCID 0000-0001-6485-7415
Nicole SolidaySaluda Medical Pty Ltd, Artarmon, New South Wales, Australia.
Angela LeitnerSaluda Medical Pty Ltd, Artarmon, New South Wales, Australia.
Erin HansonSaluda Medical Pty Ltd, Artarmon, New South Wales, Australia.
Zhonghua OuyangSaluda Medical Pty Ltd, Artarmon, New South Wales, Australia.
Dave MuganSaluda Medical Pty Ltd, Artarmon, New South Wales, Australia.
Lawrence PoreeUniversity of California San Francisco, San Francisco, California, USA.
Saluda Medical (Australia) · AUCarolinas Pain Institute · USCleveland Clinic · USInternational Spine, Pain & Performance · USPain Management Institute · USThe Spine & Nerve Centers of the Virginias · USAinsworth Institute of Pain Management · USArizona Pain Specialists · USCarolina Neurosurgery and Spine Associates · USDelaware Valley College · USEvolve Restorative Center · USHope Research Institute · USUniversity of California, San Francisco · USUniversity of Liverpool · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionA novel, spinal cord stimulation (SCS) system with a physiologic closed-loop (CL) feedback mechanism controlled by evoked compound action potentials (ECAPs) enables the optimization of physiologic neural dose and the accuracy of the stimulation, not possible with any other commercially available SCS systems. The report of objective spinal cord measurements is essential to increase the transparency and reproducibility of SCS therapy. Here, we report a cohort of the EVOKE double-blind randomized controlled trial treated with CL-SCS for 36 months to evaluate the ECAP dose and accuracy that sustained the durability of clinical improvements.

methods41 patients randomized to CL-SCS remained in their treatment allocation and were followed up through 36 months. Objective neurophysiological data, including measures of spinal cord activation, were analyzed. Pain relief was assessed by determining the proportion of patients with ≥50% and ≥80% reduction in overall back and leg pain.

resultsThe performance of the feedback loop resulted in high-dose accuracy by keeping the elicited ECAP within 4µV of the target ECAP set on the system across all timepoints. Percent time stimulating above the ECAP threshold was >98%, and the ECAP dose was ≥19.3µV. Most patients obtained ≥50% reduction (83%) and ≥80% reduction (59%) in overall back and leg pain with a sustained response observed in the rates between 3-month and 36-month follow-up (p=0.083 and p=0.405, respectively).

conclusionThe results suggest that a physiological adherence to supra-ECAP threshold therapy that generates pain inhibition provided by ECAP-controlled CL-SCS leads to durable improvements in pain intensity with no evidence of loss of therapeutic effect through 36-month follow-up.

Indexed as

Action PotentialsChronic PainEvoked PotentialsSpinal CordSpinal Cord StimulationAdultAgedDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedPain MeasurementTime FactorsTreatment OutcomeCHRONIC PAINSpinal Cord StimulationTreatment Outcome

Identifiers

PMID38490687
PMCPMC12322467
OpenAlexW4392846992

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.