Trial reportCephalalgia : an international journal of headache2013
Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: a randomized, sham-controlled study.
Trial report in Cephalalgia : an international journal of headache, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 128 papers, 7 of them syntheses that pooled 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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
128 citing papers in PubMed, 7 syntheses or guidelines pooled it, 347 citations in OpenAlex.
- Sphenopalatine ganglion stimulation: a comprehensive evaluation across diseases in randomized controlled trials.Frontiers in neurology · 2024Pooled it
- Research hotspots and frontiers of cluster headaches: a bibliometric analysis.Frontiers in neurology · 2024Pooled it
- Characterising the Features of 381 Clinical Studies Evaluating Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Relief: A Secondary Analysis of the Meta-TENS Study to Improve Future Research.Medicina (Kaunas, Lithuania) · 2022Pooled it
- Peripheral Nerve Stimulation in Pain Management: A Systematic Review.Pain physician · 2021Pooled it
- 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 · 2019Pooled it
- Sphenopalatine ganglion: block, radiofrequency ablation and neurostimulation - a systematic review.The journal of headache and pain · 2017Pooled it
- Neuromodulation of chronic headaches: position statement from the European Headache Federation.The journal of headache and pain · 2013Guideline
- Safety and efficacy of occipital nerve stimulation as treatment of chronic cluster headache: an investigator-initiated, double-blind, randomized, placebo-controlled study.The journal of headache and pain · 2026Trial
- Effect of Infusion of Calcitonin Gene-Related Peptide on Cluster Headache Attacks: A Randomized Clinical Trial.JAMA neurology · 2018Trial
- Non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A randomized, double-blind, sham-controlled ACT2 study.Cephalalgia : an international journal of headache · 2018Trial
- Upper airway stabilization by osteopathic manipulation of the sphenopalatine ganglion versus sham manipulation in OSAS patients: a proof-of-concept, randomized, crossover, double-blind, controlled study.BMC complementary and alternative medicine · 2017Trial
- Cluster headache attack remission with sphenopalatine ganglion stimulation: experiences in chronic cluster headache patients through 24 months.The journal of headache and pain · 2016Trial
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- Non-invasive vagus nerve stimulation for PREVention and Acute treatment of chronic cluster headache (PREVA): A randomised controlled study.Cephalalgia : an international journal of headache · 2016Trial
- Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic cluster headache.Cephalalgia : an international journal of headache · 2016Trial
- Trial
- Trial
- Kinetic oscillation stimulation as treatment of acute migraine: a randomized, controlled pilot study.Headache · 2015Trial
- Endoscopic transnasal sphenopalatine ganglion block for chronic craniofacial pain.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026Article
- Dual-Target SPG-Mandibular Neuromodulation for Post-Radiation Painful Trigeminal Neuropathy: A 7-Year Follow-up.Pain reports · 2026Article
68 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 6 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe pain and autonomic symptoms of cluster headache (CH) result from activation of the trigeminal parasympathetic reflex, mediated through the sphenopalatine ganglion (SPG). We investigated the safety and efficacy of on-demand SPG stimulation for chronic CH (CCH).
methodsA multicenter, multiple CH attack study of an implantable on-demand SPG neurostimulator was conducted in patients suffering from refractory CCH. Each CH attack was randomly treated with full, sub-perception, or sham stimulation. Pain relief at 15 minutes following SPG stimulation and device- or procedure-related serious adverse events (SAEs) were evaluated.
findingsThirty-two patients were enrolled and 28 completed the randomized experimental period. Pain relief was achieved in 67.1% of full stimulation-treated attacks compared to 7.4% of sham-treated and 7.3% of sub-perception-treated attacks ( P < 0.0001). Nineteen of 28 (68%) patients experienced a clinically significant improvement: seven (25%) achieved pain relief in ≥50% of treated attacks, 10 (36%), a ≥50% reduction in attack frequency, and two (7%), both. Five SAEs occurred and most patients (81%) experienced transient, mild/moderate loss of sensation within distinct maxillary nerve regions; 65% of events resolved within three months.
interpretationOn-demand SPG stimulation using the ATI Neurostimulation System is an effective novel therapy for CCH sufferers, with dual beneficial effects, acute pain relief and observed attack prevention, and has an acceptable safety profile compared to similar surgical procedures.
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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.