Evidence map›Paper›PMID 26232105›Full record

Trial reportCephalalgia : an international journal of headache2016

Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic cluster headache.

Daniel Fossum Bratbak, Ståle Nordgård, Lars Jacob Stovner, Mattias Linde, Mari Folvik, Vegard Bugten, Erling Tronvik

Registry-linked trialOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Cephalalgia : an international journal of headache, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02019017 (Endoscopic Block of the Sphenopalatine Ganglion With Botulinum Toxin in Intractable Cluster Headache - Safety Issues), which is not on this map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
5.9field-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.

NCT02019017 phase1 / phase2completednot on this map

Endoscopic Block of the Sphenopalatine Ganglion With Botulinum Toxin in Intractable Cluster Headache - Safety Issues

TypeinterventionalSponsorNorwegian University of Science and TechnologyRan2013 to 2014Enrolled10ConditionsCluster HeadacheArmsBotulinum Toxin Type A 25 IU, Botulinum Toxin Type A 50 IU
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 74 citations in OpenAlex.

  1. Pooled it
  2. Cluster headache: crosspoint between otologists and neurologists-treatment of the sphenopalatine ganglion and systematic review.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2019
    Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Hallmarks of primary headache: part 3 - cluster headache.The journal of headache and pain · 2025
    Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Article
  14. Cluster headache: state of the art in treatment.Frontiers in pain research (Lausanne, Switzerland) · 2023
    Review
  15. Review
  16. Cluster headache and TACs: state of the art.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2020
    Review
  17. Article
  18. Observational
  19. The pathophysiology of the trigeminal autonomic cephalalgias, with clinical implications.Clinical autonomic research : official journal of the Clinical Autonomic Research Society · 2018
    Review
  20. 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 2 institutions in 1 country.

Daniel Fossum BratbakDepartment of Neurosurgery, St. Olavs Hospital, Trondheim University Hospital, Norway Department of Neuroscience, Norwegian University of Science and Technology, Norway daniel.f.bratbak@ntnu.no.
Ståle NordgårdDepartment of Neuroscience, Norwegian University of Science and Technology, Norway Department of ENT, St. Olavs Hospital, Trondheim University Hospital, Norway.
Lars Jacob StovnerDepartment of Neuroscience, Norwegian University of Science and Technology, Norway Norwegian Advisory Unit on Headache, St. Olavs Hospital, Trondheim University Hospital, Norway.
Mattias LindeDepartment of Neuroscience, Norwegian University of Science and Technology, Norway Norwegian Advisory Unit on Headache, St. Olavs Hospital, Trondheim University Hospital, Norway Department of Neurology, St. Olavs Hospital, Trondheim University Hospital, Norway.
Mari FolvikDepartment of Radiology, St. Olavs Hospital, Trondheim University Hospital, Norway.
Vegard BugtenDepartment of Neuroscience, Norwegian University of Science and Technology, Norway Department of ENT, St. Olavs Hospital, Trondheim University Hospital, Norway.
Erling TronvikDepartment of Neuroscience, Norwegian University of Science and Technology, Norway Norwegian Advisory Unit on Headache, St. Olavs Hospital, Trondheim University Hospital, Norway Department of Neurology, St. Olavs Hospital, Trondheim University Hospital, Norway.
St Olav's University Hospital · NONorwegian University of Science and Technology · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe main object of this pilot study was to investigate the safety of administering onabotulinumtoxinA (BTA) towards the sphenopalatine ganglion (SPG) in intractable chronic cluster headache. Efficacy data were also collected to provide indication on whether future placebo-controlled studies should be performed.

methodIn a prospective, open-label, uncontrolled study, we performed a single injection of 25 IU (n = 5) or 50 IU BTA (n = 5) towards the SPG in 10 patients with intractable chronic cluster headache with a follow-up of 24 weeks. The primary outcome was adverse events (AEs) and the main efficacy outcome was attack frequency in weeks 3 and 4 post-treatment.

resultsA total of 11 AEs were registered. There was one severe adverse event (SAE): posterior epistaxis. The number of cluster headache attacks (main efficacy outcome) was statistically significantly reduced in the intention-to-treat analysis from 18 ± 12 per week in baseline to 11 ± 14 (p = 0.038) in weeks 3 and 4, and five out of 10 patients had at least 50% reduction of attack frequency compared to baseline. The cluster attack frequency was significantly reduced for five out of six months post-treatment.

conclusionRandomised, placebo-controlled studies are warranted to establish the potential of this possible novel treatment of cluster headache.

Indexed as

AdultBotulinum Toxins, Type ACluster HeadacheFemaleHumansIntractable PainMaleMiddle AgedNeuromuscular AgentsNeuronavigationPilot ProjectsProspective StudiesSphenopalatine Ganglion BlockTreatment OutcomeBotulinum Toxins, Type ANeuromuscular Agentsbotulinum toxinCluster headacheheadachepterygopalatine ganglionsphenopalatine ganglion

Identifiers

PMID26232105
PMCPMC4853809
OpenAlexW2269355887

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.