Evidence map›Paper›PMID 40590186›Full record

Trial reportSpine2025

ECAP-Controlled Closed-Loop Spinal Cord Stimulation for Chronic Nonsurgical Refractory Back Pain: Subgroup Analysis From Two Prospective Multicenter Clinical Trials.

Corey W Hunter, Jeffrey S Raskin, Nagy A Mekhail, Erika A Petersen, Shivanand P Lad, Jason E Pope, Shrif J Costandi, Leonardo Kapural, Ronald B Boeding, Ajay Antony and 11 more

Abstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Spine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

21 authors.

Corey W HunterAinsworth Institute of Pain Management, New York, NY.
Jeffrey S RaskinDepartment of Neurosurgery, Northwestern University Feinberg School of Medicine, Chicago, IL.
Nagy A MekhailDepartment of Pain Management, Cleveland Clinic, Cleveland, OH.
Erika A PetersenDepartment of Neurosurgery, University of Arkansas for Medical Sciences, Little Rock, AR.
Shivanand P LadDepartment of Neurosurgery, Duke University Medical Center, Durham, NC.
Jason E PopeEvolve Restorative Center, Santa Rosa, CA.
Shrif J CostandiDepartment of Pain Management, Cleveland Clinic, Cleveland, OH.
Leonardo KapuralCenter for Clinical Research, Carolinas Pain Institute, Winston-Salem, NC.
Ronald B BoedingiSpine Clinics, Maple Grove, MN.
Ajay AntonyThe Orthopaedic Institute, Gainesville, FL.
Steven M RosenDelaware Valley Pain and Spine Institute, Trevose, PA.
Robert D HerosSpinal Diagnostics, Tualatin, OR.
Dawood SayedDepartment of Anesthesiology, University of Kansas School of Medicine, Kansas City, KS.
Sean LiNational Spine and Pain Centers, Shrewsbury, NJ.
Ahmed M RaslanDepartment of Neurological Surgery, Oregon Health and Science University, Portland, OR.
G Lawson SmithDepartment of Neurosurgery, University of Arkansas for Medical Sciences, Little Rock, AR.
Johnathan H GoreeDepartment of Neurosurgery, University of Arkansas for Medical Sciences, Little Rock, AR.
Angela LeitnerSaluda Medical Pty Ltd, Macquarie Park, New South Wales, Australia.
Nicole SolidaySaluda Medical Pty Ltd, Macquarie Park, New South Wales, Australia.
Rui V DuarteSaluda Medical Pty Ltd, Macquarie Park, New South Wales, Australia.ORCID 0000-0001-6485-7415
Timothy R DeerThe Spine and Nerve Center of the Virginias, Charleston, WV.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

designSubgroup analysis of patients with chronic nonsurgical refractory back pain (NSRBP) from two prospective multicenter clinical trials to 12-month follow-up.

objectiveTo evaluate pain-related and holistic response, safety events as well as neurophysiological metrics associated with the use of evoked compound action potential (ECAP)-controlled closed-loop spinal cord stimulation (SCS) for patients with chronic back pain without prior surgery. SUMMARY OF BACKGROUND DATA: Innovations in SCS such as the development of physiological ECAP-controlled closed-loop SCS overcome limitations of traditional, fixed-output SCS for the treatment of NSRBP. The outcomes of closed-loop SCS to 12-month follow-up for patients with NSRBP have not been previously reported. MATERIALS AND

methodsPatient-reported outcome measures for pain intensity, physical function, health-related quality of life, sleep quality, and emotional function were collected from 68 patients with NSRBP in two prospective multicenter clinical trials. Change in opioid use, its reduction or elimination were assessed at 12-month follow-up. A validated composite outcome measure comprising the different health domains was used to evaluate holistic treatment response through minimal clinically important differences (MCIDs). Objective device metrics provide information on system utilization, loop performance (dose accuracy), and neurophysiological dose metrics.

resultsAt 12 months, 79% of patients reported ≥50% reduction in pain intensity and 48% obtained ≥80% pain relief. Significant improvements in all patient-reported outcome measures assessed were observed at 3 and 12 months. Voluntary reduction or elimination of opioid use was observed in approximately half of the patients that were taking opioids at baseline. System utilization was >80%, dose ratio was >1.3 ( i.e. 30% above ECAP threshold) with a high-dose accuracy keeping the elicited ECAP within 3.5 μV of the target ECAP set on the system.

conclusionECAP-controlled closed-loop SCS represents a safe and effective treatment option for patients with NSRBP.

Indexed as

Action PotentialsBack PainChronic PainSpinal Cord StimulationAdultAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedPain MeasurementPatient Reported Outcome MeasuresProspective StudiesQuality of LifeTreatment Outcomeclosed-loopevoke-compound action potentialneurophysiological dose metricsnonsurgical refractory back painPersistent Spinal Pain Syndrome Type 1spinal cord stimulation

Identifiers

PMID40590186
PMCPMC12594148

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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.