Evidence map›Paper›PMID 31342515›Full record

Trial reportHeadache2019

Pilot Study of Injection of OnabotulinumtoxinA Toward the Sphenopalatine Ganglion for the Treatment of Classical Trigeminal Neuralgia.

Joan Crespi, Daniel Bratbak, David W Dodick, Manjit Matharu, Kent Are Jamtøy, Erling Tronvik

Registry-linked trialOpen access · hybridAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Headache, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02662972 (Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
1.2field-weighted citation impact, top 21% 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.

NCT02662972 phase1 / phase2completednot on this map

Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.

TypeinterventionalSponsorNorwegian University of Science and TechnologyRan2016 to 2018Enrolled10ConditionsTrigeminal Neuralgia, Headache DisordersArmsBotulinum Toxin Type A
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Review
  6. Pathophysiology and Management of Refractory Trigeminal Neuralgia.Current neurology and neuroscience reports · 2024
    Review
  7. Observational
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. 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

6 authors at 4 institutions in 3 countries.

Joan CrespiDepartment of Neurology, St. Olav's University Hospital, Trondheim, Norway.
Daniel BratbakDepartment of Neuromedicine and Movement Science, NTNU (University of Science and Technology), Trondheim, Norway.
David W DodickDepartment of Neuromedicine and Movement Science, NTNU (University of Science and Technology), Trondheim, Norway.
Manjit MatharuUCL Queen Square Institute of Neurology, National Hospital for Neurology and Neurosurgery, London, UK.
Kent Are JamtøyDepartment of Neuromedicine and Movement Science, NTNU (University of Science and Technology), Trondheim, Norway.
Erling TronvikDepartment of Neurology, St. Olav's University Hospital, Trondheim, Norway.
Norwegian University of Science and Technology · NOSt Olav's University Hospital · NOMayo Clinic in Arizona · USUniversity College London · GB

Funding

NTNU (Norwegian University of Science and Technology) and "The Liaison Committee for Education, Research and Innovation in Central Norway" (Samarbeidsorganet) 46056923
6 · The paper itself

Abstract

backgroundThe sphenopalatine ganglion (SPG) has previously been targeted in trigeminal neuralgia (TN), but its role in this condition has not been established.

objectiveTo investigate the safety of injecting onabotulinumtoxinA (BTA) toward the SPG using the MultiGuide

methodsTwenty-five international units (IU) of BTA were injected toward the SPG in a prospective, open-label study in 10 patients with refractory classical TN. All patients were recruited and treated on an out-patient basis at St. Olav's University Hospital in Trondheim (Norway). PRIMARY OUTCOME: adverse events (AEs). Primary efficacy outcome: number of TN attacks at weeks 5-8 after injection compared to baseline. A treatment responder was predefined as at least 50% reduction in the median number of attacks per day between baseline and weeks 5-8. Other efficacy outcomes were intensity of attacks (numeric rating scale, 0 to 10) and functional level (1 to 4; 1 best and 4 worst) at weeks 5-8 after injection compared to baseline. Percentage of the day with concomitant persistent pain was registered at baseline and at weeks 1-4, 6, 8, and 12 after injection. Patient global impression of change (PGIC) was ascertained at month 3.

resultsFor the primary endpoint, we analyzed data for all 10 patients. For efficacy outcomes we analyzed data for 9 patients (1 patient violated protocol). We registered 13 AEs, none of which were serious. The median number of TN attacks during the 4-week baseline and weeks 5-8 after injection was 5.5 (range: 1.0-51.5) and 5 (range: 0-225.0), respectively (P = .401). Four patients were treatment responders. The median intensity of attacks at baseline and weeks 5-8 after injection was 6 (range: 3.0-8.5) and 3 (range: 0.0-9.0) respectively (P = .024). The median functional level at baseline was 2 (range: 1.0-3.3) and at month 2, 1 (range 1.0-4.0; P = .750). Median percentage of the day with concomitant persistent pain was 75% (minimum 37.5%, maximum 100%) at baseline and 18.75% (minimum 0%, maximum 100%) at week 8 (P = .023).

conclusionsInjection of BTA toward the SPG using the MultiGuide

Indexed as

AdultAgedBotulinum Toxins, Type AFemaleHumansInjectionsMaleMiddle AgedNeuromuscular AgentsPilot ProjectsPterygopalatine FossaTrigeminal NeuralgiaBotulinum Toxins, Type ANeuromuscular Agentsbotulinum toxinpterygopalatine ganglionsensitizationsphenopalatine gangliontrigeminal neuralgia

Identifiers

PMID31342515
PMCPMC6771650
OpenAlexW2963606701

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.