Trial reportThe journal of headache and pain2016
Cluster headache attack remission with sphenopalatine ganglion stimulation: experiences in chronic cluster headache patients through 24 months.
Trial report in The journal of headache and pain, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03567590 (A Prospective, Multicentre, Randomized, Controlled, Blinded-endpoint Study to Evaluate the Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Cluster Headache), which is not on this map. Cited by 19 papers, 3 of them syntheses that pooled it.
What it found
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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.
A Prospective, Multicentre, Randomized, Controlled, Blinded-endpoint Study to Evaluate the Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Cluster Headache
Who cites it
19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 58 citations in OpenAlex.
- Stereotactic radiosurgery in the management of cluster headache: evidence from a systematic review and meta-analysis.Neurosurgical review · 2026Pooled 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
- Hallmarks of primary headache: part 3 - cluster headache.The journal of headache and pain · 2025Review
- Neuromodulation for the Sphenopalatine Ganglion-a Narrative Review.Current pain and headache reports · 2023Review
- Review
- Cluster headache: state of the art in treatment.Frontiers in pain research (Lausanne, Switzerland) · 2023Review
- Neurostimulation Treatment in Chronic Cluster Headache-a Narrative Review.Current pain and headache reports · 2021Review
- [Neuromodulation in primary headache in the year 2019: is it still up-to-date? : New data on invasive and non-invasive neuromodulation in migraine and cluster headaches].Schmerz (Berlin, Germany) · 2019Review
- Migraine: Experimental Models and Novel Therapeutic Approaches.International journal of molecular sciences · 2019Review
- The Evolution of Neuromodulation in the Treatment of Chronic Pain: Forward-Looking Perspectives.Pain medicine (Malden, Mass.) · 2019Review
- Article
- Sphenopalatine Ganglion Block and Radiofrequency Ablation: Technical Notes and Efficacy.Ochsner journal · 2019Review
- Pre- and postnatal development of the otic ganglion in humans.Journal of anatomy · 2019Article
- Non-invasive vagus nerve stimulation for treatment of cluster headache: early UK clinical experience.The journal of headache and pain · 2018Article
- A new era in headache treatment.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2018Review
- Treatment of the Patient with Refractory Headache.Current pain and headache reports · 2018Review
- Sphenopalatine ganglion stimulation for cluster headache, results from a large, open-label European registry.The journal of headache and pain · 2018Article
- New treatments for headache.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCluster headache (CH) is a debilitating headache disorder with severe consequences for patient quality of life. On-demand neuromodulation targeting the sphenopalatine ganglion (SPG) is effective in treating the acute pain and a subgroup of patients experience a decreased frequency of CH attacks.
methodsWe monitored self-reported attack frequency, headache disability, and medication intake in 33 patients with medically refractory, chronic CH (CCH) in an open label follow-up study of the original Pathway CH-1 study. Patients were followed for at least 24 months (average 750 ± 34 days, range 699-847) after insertion of an SPG microstimulator. Remission periods (attack-free periods exceeding one month, per the ICHD 3 (beta) definition) occurring during the 24-month study period were characterized. Attack frequency, acute effectiveness, medication usage, and questionnaire data were collected at regular clinic visits. The time point "after remission" was defined as the first visit after the end of the remission period.
resultsThirty percent (10/33) of enrolled patients experienced at least one period of complete attack remission. All remission periods followed the start of SPG stimulation, with the first period beginning 134 ± 86 (range 21-272) days after initiation of stimulation. On average, each patient's longest remission period lasted 149 ± 97 (range 62-322) days. The ability to treat acute attacks before and after remission was similar (37 % ± 25 % before, 49 % ± 32 % after; p = 0.2188). Post-remission headache disability (HIT-6) was significantly improved versus baseline (67.7 ± 6.0 before, 55.2 ± 11.4 after; p = 0.0118). Six of the 10 remission patients experienced clinical improvements in their preventive medication use. At 24 months post insertion headache disability improvements remained and patient satisfaction measures were positive in 100 % (10/10).
conclusionsIn this population of 33 refractory CCH patients, in addition to providing the ability to treat acute attacks, neuromodulation of the SPG induced periods of remission from cluster attacks in a subset of these. Some patients experiencing remission were also able to reduce or stop their preventive medication and remissions were accompanied by an improvement in headache disability.
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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.