Evidence map›Paper›PMID 27906080›Full record

Trial reportTrials2016

Tonic and burst spinal cord stimulation waveforms for the treatment of chronic, intractable pain: study protocol for a randomized controlled trial.

Konstantin V Slavin, Richard B North, Timothy R Deer, Peter Staats, Kristina Davis, Roni Diaz

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02011893 (Success Using Neuromodulation With BURST), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
6.2field-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.

NCT02011893 nacompletednot on this map

Success Using Neuromodulation With BURST (SUNBURST™) Study

TypeinterventionalSponsorAbbott Medical DevicesRan2013 to 2017Enrolled173ConditionsChronic PainArmsTonic Stimulation, Burst Stimulation
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 30 citations in OpenAlex.

  1. Trial
  2. Trial
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  4. Review
  5. Review
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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

6 authors at 3 institutions in 1 country.

Konstantin V SlavinDepartment of Neurosurgery, University of Illinois College of Medicine, 912 South Wood St, Chicago, IL, USA. kslavin@uic.edu.
Richard B NorthDepartments of Neurosurgery, Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Timothy R DeerCenter for Pain Relief, 400 Court St #100, South Charleston, WV, USA.
Peter StaatsPremier Pain Centers, 170 Avenue at the Common, Shrewsbury, NJ, USA.
Kristina DavisSt. Jude Medical, 6901 Preston Rd., Plano, TX, USA.
Roni DiazSt. Jude Medical, 6901 Preston Rd., Plano, TX, USA.
St. Jude Medical Center · USIllinois College · USJohns Hopkins University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBurst stimulation is a novel form of neurostimulation for the treatment of chronic pain which has demonstrated promise in small uncontrolled studies, but has not yet gained approval for use in the U.S. We report the study methods for an ongoing multicenter, randomized, controlled, cross-over study designed to gain United States Food and Drug Administration (FDA) approval for burst stimulation.

methodsParticipants who are candidates for a currently approved neurostimulation device were enrolled and screened. Participants who fail a tonic trial evaluation, have significant depressive symptoms, or evidence lack of compliance with study procedures by failing to complete 7 days of a Pain Diary are excluded. Participants receiving a permanent implant are randomized to receive: (1) 12 weeks of tonic followed by 12 weeks of burst stimulation or (2) 12 weeks of burst stimulation followed by 12 weeks of tonic stimulation. Assessments occur at 6, 12, 18, and 24 weeks. After 24 weeks, participants choose their preferred therapy and are assessed every 6 months for up to 2 years. All patients had the device leads inserted at the site of a successful tonic stimulation trial. Assessments include: a Pain Diary using a Visual Analog Scale (VAS) for overall, trunk, and limb pain, the Beck Depression Inventory, the Pain Catastrophizing Scale, the Oswestry Disability Index, paresthesia, satisfaction, and therapy preference. Reported adverse events are collected throughout the study. The primary endpoint is the noninferiority of burst stimulation compared to tonic measured by the within-subject difference in the mean overall VAS score at the end of each 12-week stimulation period. DISCUSSION: This trial represents the largest controlled trial of burst stimulation to date, and is expected to yield important information regarding the safety and efficacy of burst stimulation.

trial registrationClinicalTrials.gov, NCT02011893 . Registered on 10 December 2013.

Indexed as

Clinical ProtocolsSpinal Cord StimulationChronic PainCross-Over StudiesHumansIntractable PainSample SizeBurst stimulationComparative efficacyNeuromodulationProspectiveRandomizedSpinal cord StimulationTonic stimulation

Identifiers

PMID27906080
PMCPMC5131423
OpenAlexW2559526509

What OpenQuestion holds

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LicenceCC BY
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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.