Evidence map›Paper›PMID 31331265›Full record

Trial reportThe journal of headache and pain2019

Remote electrical neuromodulation (REN) in the acute treatment of migraine: a comparison with usual care and acute migraine medications.

Alan M Rapoport, Jo H Bonner, Tamar Lin, Dagan Harris, Yaron Gruper, Alon Ironi, Robert P Cowan

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

Trial report in The journal of headache and pain, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03361423 (A Randomized, Double Blinded, Sham Controlled Clinical Study to Evaluate the Safety and Efficacy of the Nerivio Migra 1, a Neuromodulation Device, for the Acute Treatment of Migraine), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
5.8field-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.

NCT03361423 nacompletednot on this map

A Randomized, Double Blinded, Sham Controlled Clinical Study to Evaluate the Safety and Efficacy of the Nerivio Migra 1, a Neuromodulation Device, for the Acute Treatment of Migraine

TypeinterventionalSponsorTheranicaRan2017 to 2018Enrolled296ConditionsMigraine Without Aura, Migraine With AuraArmsNerivio Migra-1 active device, Nerivio Migra-1 Sham device
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 47 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Non-Pharmacological Treatment for Chronic Migraine.Current pain and headache reports · 2023
    Review
  7. Article
  8. New Approaches to Shifting the Migraine Treatment Paradigm.Frontiers in pain research (Lausanne, Switzerland) · 2022
    Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
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

7 authors at 3 institutions in 1 country.

Alan M RapoportThe David Geffen School of Medicine, UCLA, California, Los Angeles, USA. alanrapoport@gmail.com.
Jo H BonnerMercy Clinic Neurology & Headache Cente, St. Louis, MO, USA.
Tamar LinTheranica Bio-Electronics LTD, Netanya, Israel.
Dagan HarrisTheranica Bio-Electronics LTD, Netanya, Israel.
Yaron GruperTheranica Bio-Electronics LTD, Netanya, Israel.
Alon IroniTheranica Bio-Electronics LTD, Netanya, Israel.
Robert P CowanSchool of medicine, Stanford University, Stanford, CA, USA.
Mercy Clinic Neurology · USStanford University · USUniversity of California, Los Angeles · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is a significant unmet need for new, effective and well tolerated acute migraine treatments. A recent study has demonstrated that a novel remote electrical neuromodulation (REN) treatment provides superior clinically meaningful pain relief with a low rate of device-related adverse events. The results reported herein compare the efficacy of REN with current standard of care in the acute treatments of migraine.

methodsWe performed a post-hoc analysis on a subgroup of participants with migraine from a randomized, double-blind, parallel-group, sham-controlled, multicenter study on acute care. The original study included a 2-4 weeks run-in phase, in which migraine attacks were treated according to patient preference (i.e., usual care) and reported in an electronic diary; next, participants entered a double-blind treatment phase in which they treated the attacks with an active or sham device. The efficacy of REN was compared to the efficacy of usual care or pharmacological treatments in the run-in phase in a within-subject design that included participants who treated at least one attack with the active REN device and reported pain intensity at 2 h post-treatment.

resultsOf the 252 patients randomized, there were 99 participants available for analysis. At 2 h post-treatment, pain relief was achieved in 66.7% of the participants using REN versus 52.5% participants with usual care (p < 0.05). Pain relief at 2 h in at least one of two attacks was achieved by 84.4% of participants versus 68.9% in usual care (p < 0.05). REN and usual care were similarly effective for pain-free status at 2 h. The results also demonstrate the non-inferiority of REN compared with acute pharmacological treatments and its non-dependency on preventive medication use.

conclusionREN is an effective acute treatment for migraine with non-inferior efficacy compared to current acute migraine therapies. Together with a very favorable safety profile, these findings suggest that REN may offer a promising alternative for the acute treatment of migraine and could be considered first line treatment in some patients.

trial registrationClinicalTrials.gov NCT03361423 . Registered 18 November 2017.

Indexed as

Electric Stimulation TherapyAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedMigraine DisordersPain ManagementTreatment OutcomeYoung AdultAcute treatmentConditioned pain modulationHeadacheMigraineNeuromodulationNon-pharmacological treatmentRemote electrical neuromodulation

Identifiers

PMID31331265
PMCPMC6734294
OpenAlexW2965633563

What OpenQuestion holds

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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.