Evidence map›Paper›PMID 33296127›Full record

ArticleNeuromodulation : journal of the International Neuromodulation Society2021

Long-Term Efficacy of a Novel Spinal Cord Stimulation Clinical Workflow Using Kilohertz Stimulation: Twelve-Month Results From the Vectors Study.

John A Hatheway, Vipul Mangal, Michael A Fishman, Philip Kim, Binit Shah, Rainer Vogel, Vincent Galan, Steven Severyn, Tristan E Weaver, David A Provenzano and 10 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neuromodulation : journal of the International Neuromodulation Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03345472 (Vectors Post Market), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

NCT03345472 nacompletednot on this map

Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation (SCS) With High Dose (HD) Stimulation Parameters

TypeinterventionalSponsorMedtronicNeuroRan2017 to 2019Enrolled175ConditionsChronic PainArmsSpinal Cord Stimulation System
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

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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

20 authors.

John A HathewayNorthwest Pain Care, Spokane, WA, USA.
Vipul MangalNational Spine & Pain Center, National Harbor, MD, USA.
Michael A FishmanCenter for Interventional Pain & Spine, Wilmington, DE, USA.ORCID https://orcid.org/0000-0002-6051-5909
Philip KimCenter for Interventional Pain & Spine, Wilmington, DE, USA.ORCID https://orcid.org/0000-0003-0249-078X
Binit ShahCarolinas Pain Center, Huntersville, NC, USA.
Rainer VogelComprehensive and Interventional Pain Management, Henderson, NV, USA.
Vincent GalanPain Care, Stockbridge, GA, USA.
Steven SeverynThe Ohio State University Wexner Medical Center, Columbus, OH, USA.
Tristan E WeaverThe Ohio State University Wexner Medical Center, Columbus, OH, USA.
David A ProvenzanoPain Diagnostics and Interventional Care, Sewickley, PA, USA.
Eric ChangRestore Orthopedics & Spine Center, Orange, CA, USA.
Michael H VerdolinPain Consultants of San Diego, La Mesa, CA, USA.
Gregory HowesCarilion Roanoke Memorial Hospital, Roanoke, VA, USA.
Armando VillarrealUniversity of Rochester Neurosurgery Partners Pain Management, Rochester, NY, USA.
Steven FalowskiSaint Luke's Neurosurgical Associates, Bethlehem, PA, USA.ORCID https://orcid.org/0000-0003-3996-087X
Kelly HendricksonMedtronic, Fridley, MN, USA.
Katherine StrombergMedtronic, Fridley, MN, USA.
Lachlan DaviesMedtronic, Fridley, MN, USA.
Lisa JohanekMedtronic, Fridley, MN, USA.
Matthew T KellyMedtronic, Fridley, MN, USA.ORCID https://orcid.org/0000-0003-1215-5256

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesMultiple variables play a role in spinal cord stimulation (SCS) treatment outcomes, including patient anatomy, pain pattern, lead location, stimulation parameters, and so on. A wide range of stimulation parameters are considered safe and on-label, and as a result a growing number of new frequencies and frequency-combinations are being incorporated into standard practice. A standardized approach to therapy delivery may provide more consistent outcomes for more patients. The Vectors study evaluated whether there is significant sustained improvement in pain and functional outcomes when therapy is delivered using a standardized approach. MATERIALS AND

methodsVectors, a post-market, single-arm study evaluated the safety and efficacy of SCS with an implantable neurostimulator starting with 1 kHz stimulation, targeting the T9-T10 disc space following paresthesia mapping. Subjects with chronic intractable low back and leg pain (visual analogue scale [VAS] ≥ 50 mm) were enrolled. The primary endpoint was change in overall pain (VAS) at the three-month visit compared to baseline. Subjects were followed through 12 months. Secondary endpoints included changes in low back and leg pain, quality of life (European Quality of Life - Five Dimensions, EQ-5D-5L), disability (Oswestry Disability Index, ODI), individual subject goals, and subject satisfaction.

resultsThere was a significant reduction in overall pain (VAS; 45.4 mm) through the three-month visit, which was sustained through 12 months. At 12 months, 79% of subjects had ≥50% improvement in at least one pain domain (overall, lowback or leg) with 85% of subjects reporting therapy satisfaction. There was a decrease in disability and an improvement in quality of life with 70% of subjects achieving a personal activity goal by the three-month visit.

conclusionsLong-term pain relief and improvement in quality of life and function were achieved when following a standardized workflow. CLINICAL

trial registrationThe Clinicaltrials.gov registration number for the study is NCT03345472.

Indexed as

Chronic PainSpinal Cord StimulationHumansPain MeasurementQuality of LifeSpinal CordTreatment OutcomeWorkflowChronic neuropathic painfunctional outcomeshigh-frequency stimulationpain reliefprospective

Identifiers

PMID33296127
PMCPMC8246544

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Registered trials

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.