Evidence map›Paper›PMID 26156114›Full record

Trial reportThe journal of headache and pain2015

Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial.

Andreas Straube, J Ellrich, O Eren, B Blum, R Ruscheweyh

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The journal of headache and pain, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 143 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
143citing papers in PubMed, 11 pooled it
12.0field-weighted citation impact, top 1% 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.

NCT04260906 nacompletednot on this mapstarted 2017, after this paper: background citation

The Impact Of Auricular Vagus Nerve Stimulation On Pain And Life Quality In Patients With Fibromyalgia Syndrome

TypeinterventionalSponsorBahçeşehir UniversityRan2017 to 2019Enrolled60ConditionsFibromyalgia, Myofascial Pain SyndromeArmsVagus nerve stimulator, exercise
NCT04768738 nacompletednot on this mapstarted 2020, after this paper: background citation

The Effect Of Transcutaneous Auricular Vagus Nerve Stimulation On Sports Performance And Physiological Parameters In Healthy Young Individuals: Randomized, Double-Blind Study

TypeinterventionalSponsorSinop UniversityRan2020 to 2020Enrolled46ConditionsHealthy, Activity, MotorArmsAuricular Vagus Nerve Stimulation Level Of Above Threshold, Auricular Vagus Nerve Stimulation Level Of Subthreshold, Auricular Vagus Nerve Stimulation Sham Method, 5 Minutes Bicycle Exercise
3 · Its place in the literature

Who cites it

143 citing papers in PubMed, 11 syntheses or guidelines pooled it, 304 citations in OpenAlex.

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83 more citing papers are in PubMed but not listed here.

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

5 authors at 3 institutions in 2 countries.

Andreas StraubeKlinik und Poliklinik für Neurologie, Oberbayerisches Kopfschmerzzentrum, Klinikum Großhadern, Ludwig-Maximilians-Universität München, Marchioninistr. 15, 81377, Munich, Germany, Andreas.Straube@med.uni-muenchen.de.
J Ellrich
O Eren
B Blum
R Ruscheweyh
Klinik und Poliklinik für Neurologie · DEAalborg University · DKLudwig-Maximilians-Universität München · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAim of the study was assessment of efficacy and safety of transcutaneous stimulation of the auricular branch of the vagal nerve (t-VNS) in the treatment of chronic migraine.

methodsA monocentric, randomized, controlled, double-blind study was conducted. After one month of baseline, chronic migraine patients were randomized to receive 25 Hz or 1 Hz stimulation of the sensory vagal area at the left ear by a handhold battery driven stimulator for 4 h/day during 3 months. Headache days per 28 days were compared between baseline and the last month of treatment and the number of days with acute medication was recorded The Headache Impact Test (HIT-6) and the Migraine Disability Assessment (MIDAS) questionnaires were used to assess headache-related disability.

resultsOf 46 randomized patients, 40 finished the study (per protocol). In the per protocol analysis, patients in the 1 Hz group had a significantly larger reduction in headache days per 28 days than patients in the 25 Hz group (-7.0 ± 4.6 vs. -3.3 ± 5.4 days, p = 0.035). 29.4 % of the patients in the 1 Hz group had a ≥50 % reduction in headache days vs. 13.3 % in the 25 Hz group. HIT-6 and MIDAS scores were significantly improved in both groups, without group differences. There were no serious treatment-related adverse events.

conclusionTreatment of chronic migraine by t-VNS at 1 Hz was safe and effective. The mean reduction of headache days after 12 weeks of treatment exceeded that reported for other nerve stimulating procedures.

Indexed as

AdultChronic DiseaseDouble-Blind MethodFemaleHumansMaleMiddle AgedMigraine DisordersPain ManagementProspective StudiesSurveys and QuestionnairesTranscutaneous Electric Nerve StimulationTreatment OutcomeVagus Nerve

Identifiers

PMID26156114
PMCPMC4496420
OpenAlexW2115043276

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.