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IRCT20190618043923N6 IRCT 2022-07-17 Tabriz University of Medical Sciences Effect of Orthokin therapy and radiofrequency ablation in the treatment for idiopathic trigeminal neuralgia Comparison of Orthokin therapy and radiofrequency ablation in the treatment for idiopathic trigeminal neuralgia 2022-03-04 anticipated 46 Complete https://irct.ir/trial/63093 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be assigned to two groups using block randomization using random allocation software (RAS). The size of blocks is 4 including the equal numbers of each intervention of the study in each block and a 1:1 assignment ratio. Blocking will be performed by the non-involved person in data sampling and analysis. To conceal the assignment, the type of intervention will be written on a sheet of paper coding using the letters A and B and placed inside matted, consecutively numbered envelopes. The envelopes will be arranged according to the participants' entry into the intervention, and the type of group will be revealed, Blinding description: The present study is a single-blinded study. Participants will not be aware of the random allocation sequences. 3 Idiopathic trigeminal neuralgia. Intervention 1: Intervention group 1: Injection of 2 ml of orthokine, 4 times (once a week) each with a dose of 2 milliliters under fluoroscopic guide through foramen oval with 22 spinal needles. Intervention 2: Intervention group 1: Radiofrequency ablation under the fluoroscopic guide. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information.
public Dawood Aghamohammadi
Tabriz University of Medical Sciences, University Street
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3336 1928 daghamohamadi@yahoo.com Tabriz University of Medical Sciences scientific Dawood Aghamohammadi
Tabriz University of Medical Sciences, University Street
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3336 1928 daghamohamadi@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Confirmation of idiopathic trigeminal neuralgia, based on diagnostic criteria of the International Headache Association Trigeminal neuralgic pain, with an intensity of 40 to 100 based on the visual analog scale of 100 mm 18 years 70 years Both Bleeding disorders Active infection Type 2 diabetes Patients with pacemaker Patients with internal drug injection devices Neoplasm Drug addiction Psychopathy Drug sensitivity Pregnancy and lactation G50.9 Disorder of trigeminal nerve, unspecified Treatment - Drugs Treatment - Drugs Intervention group 1: Injection of 2 ml of orthokine, 4 times (once a week) each with a dose of 2 milliliters under fluoroscopic guide through foramen oval with 22 spinal needles Intervention group 1: Radiofrequency ablation under the fluoroscopic guide حain intensity. Timepoint: Pain intensity at the beginning of the study (before the intervention) and 7, 14 and 21 days after the start of intervention. Method of measurement: 100-mm Visual Analogue Scale. Analgesic consumption. Timepoint: Analgesic consumption at the beginning of the study (before the intervention) and 7, 14, and 21 days after the intervention. Method of measurement: Self-reported. Tabriz University of Medical Sciences Approved 2022-03-02 Ethics committee of Tabriz University of Medical Sciences Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave Tabriz East Azarbaijan Iran (Islamic Republic of)