SPG Pulsed Radiofrequency for Chronic Cluster Headache
The Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Chronic Cluster Headache
Beijing Tiantan Hospital
108 participants
Jan 24, 2025
INTERVENTIONAL
Conditions
Summary
Cluster headache (CH) is a devastating disorder characterized by ipsilateral headache and associated trigeminal autonomic symptoms, with a yearly prevalence of 0.1%. There is a huge clinically unmet demand for an effective therapeutic method for CH. Previous evidences indicate that pulse radiofrequency (PRF) targeting the sphenopalatine ganglion (SPG) is a safe, minimally invasive, effective treatment for CH. This randomized, controlled trial aimed to establish the safety and efficacy of SPG PRF for patients with chronic CH.
Eligibility
Inclusion Criteria4
- Chronic cluster headache;
- At least four attacks per week;
- Minimum age of 18 years;
- Non-response to verapamil and lithium treatment in the past, intolerance, or contraindication to verapamil and lithium, along with non-response, intolerance, or contraindica-tion to topiramate, or gabapentin.
Exclusion Criteria7
- Pregnancy or breastfeeding;
- Presence of cardiac pacemaker or other neuromodulatory devices;
- Pyschiatric and cognitive disorders;
- Serious drug habituation or overuse of acute-headache medication;
- History of stroke or intracranial aneurysm, or at risk for serious or acute cardiovascular events;
- Infection at the puncture site;
- Previous history of invasive treatments such as sphenopalatine ganglion radiofrequency thermocoagulation and chemical destruction.
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Interventions
After the puncture needle reached the sphenopalatine ganglion (SPG), patients in the PRF group received PRF treatment in automatic mode for 360 s, at a maximum of 42°C, pulse frequency of 2 Hz, and pulse width of 20 ms.
After the puncture needle reached the sphenopalatine ganglion (SPG), patients in the NB group received nerve block with a mixture of 40 mg of triamcinolone and 2 ml of 0.75% bupivacaine with 2 ml of normal saline and 1:100000 epinephrine.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06787677