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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
108
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.
Fang Luo
Beijing, Beijing Municipality, China
RECRUITINGThe mean attack frequency in the last 4 weeks (week 8-12) after procedure
The overall mean change from baseline in mean weekly attack frequency
Time frame: In the last 4 weeks (week 8-12) after procedure
Mean attack frequency
Mean change in mean attack frequency
Time frame: From baseline to each 4-week interval through 1 year after procedure
50% reduction of mean attack frequency
Percentage of patients with a 50% reduction in mean attack frequency
Time frame: From baseline to each 4-week interval through 1 year after procedure
30% reduction of mean attack frequency
Percentage of patients with a 30% reduction in mean attack frequency
Time frame: From baseline to each 4-week interval through 1 year after procedure
Patient Global Impression of Improvement
Percentage of patients reporting a score of 1 (''very much better'') or 2 (''much better'')
Time frame: At month 1, month 2, month 3, month 6, and month 12 after procedure
Mean attack intensity
0-10 on the numeric rating scale, with 0 equating no pain and 10 the worst pain possible
Time frame: From baseline to each 4-week interval through 1 year after procedure
Patient satisfaction scores
0 point indicates unsatisfied to 10 points indicate very satisfied. The higher the score, the more dissatisfied the patient is.
Time frame: At month 1, month 2, month 3, month 6, and month 12 after procedure
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The incidence of perioperative adverse events
Perioperative adverse events (AEs) including headache, dizziness, nausea, vomiting, facial hematoma, and numbness in the area innervated by the maxillary nerve
Time frame: Across 1 year after procedure