The investigators aim to investigate the effectiveness and safety of sphenopalatine ganglion pulsed radiofrequency on cluster headache.
The investigators aim to investigate whether the sphenopalatine ganglion pulsed radiofrequency treatment is better than traditional sphenopalatine ganglion nerve block technology and provides medical evidence for the clinical application and promotion of sphenopalatine ganglion pulsed radiofrequency treatment to provide a minimally invasive, safe, and effective treatment for patients with cluster headache who do not respond to drug treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
The pulse treatment generator (PMF-21-100-5, Baylis Medical Inc., Montreal, Canada) with a length of 10 cm, 21-gauge, and an active tip length of 5 mm is inserted vertically into the puncture point. The pulse treatment generator is set to the pulsed radiofrequency automatic mode, with a temperature of 42 °C, pulse frequency of 2 Hz, pulse width of 20 ms, and treatment duration of 360s.
A mixture of 40 mg Triamcinolone + 2 ml of 1% Bupivacaine + 2 ml of 2% mepivacaine + 1:100000 epinephrine is injected for nerve block treatment using a puncture needle.
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Beijing Sanbo Brain Hospital
Beijing, Beijing Municipality, China
Jilin Province People's Hospital
Changchun, Jilin, China
Duration of the cluster period
The duration of the cluster period is defined as the total duration of the headache, including the pain attack time before and after treatment.
Time frame: Within 1 year (the cluster period is not over 3 months generally)
The degree of pain during headache attacks after treatment
Evaluated by numeric rating scale (NRS, 0 points for no pain and 10 points for the most severe pain)
Time frame: 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery
Headache attack frequency
The number of attacks per day
Time frame: 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery
Duration of each headache attack
Duration of each headache attack after treatment
Time frame: 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery
Dose of auxiliary analgesic drugs
Dose of auxiliary analgesic drugs per day
Time frame: 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery
Duration of remission period
From the end of this cluster period to the beginning of the next cluster period
Time frame: 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery
Patient satisfaction
Patient satisfactory scale (PSS) evaluation (0 for unsatisfactory, and 10 for very satisfied).
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Time frame: 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery
Effective rate
The effectiveness rate is calculated as follows: effectiveness rate = the number of effective patients / total number of patients in this group × 100%.
Time frame: 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery