About this trial
This study aims to compare between the Efficacy and safety of irregular pulsed radiofrequency STP versus regular pulsed radiofrequency to the gasserian ganglion for treatment of primary trigeminal neuralgia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of primary trigeminal neuralgia according to the International Classification of Headache Disorders, 3rd edition (ICHD-3)
Age between 18 and 75 years
Severe trigeminal neuralgia not adequately relieved by conservative medical therapy, including carbamazepine or oxcarbazepine
Numeric Rating Scale (NRS-11) pain score of 7 or higher prior to the procedure
Disqualifiers
Secondary trigeminal neuralgia, including trigeminal neuralgia attributed to space-occupying lesions or multiple sclerosis
Infection at the puncture site
History of psychiatric disease
Clinically significant abnormalities in routine laboratory tests, including hepatic, renal, or coagulation function, or abnormalities on electrocardiogram or chest X-ray
Trial design
Parallel
Treatments tested in this trial
Irregular pulsed Radiofrequency
Procedure/Surgeryirregular pulsed radiofrequency applied to gasserian ganglion for primary trigeminal neuralgia
Regular pulsed Radiofrequency
Procedure/SurgeryRegular pulsed radiofrequency applied to gasserian ganglion for primary trigeminal neuralgia
Treatment groups
Trial outcomes
Primary outcomes
change in pain intensity
• Pain intensity of the attacks using VAS (''0'' no pain to ''10'' worst possible pain) day 1, after 1and 2 weeks and after 1,2,3 and 6 months. And dose of carbamazepine or oxcarbazepine will be recorded on day 1 after 1 and 2 weeks, and after 1, 2, 3 and 6 months following the procedure.
Locations
Sponsors and contacts
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