]>
IRCT20231113060043N1 IRCT 2023-12-23 Mazandaran University of Medical Sciences The effect of superior cervical sympathetic ganglion block using radiofrequency in the treatment of tinnitus The effect of superior cervical sympathetic ganglion block using radiofrequency in the treatment of adult patients with tinnitus 2023-11-19 anticipated 40 Complete https://irct.ir/trial/73780 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be included in the study based on a randomly prepared list. This list contains a series of random numbers, each number is assigned to a type of treatment and according to that treatment is done. 1, 4, 1, Group Ganglion Block 1, 4, 2, Cinnarizine 1, 4, 3, Cinnarizine 1, 4, 4, Group Ganglion Block 2, 4, 1, Group Ganglion Block 2, 4, 2, Cinnarizine 2, 4, 3, Group Ganglion Block 2, 4, 4, Cinnarizine 3, 4, 1, Cinnarizine 3, 4, 2, Group Ganglion Block 3, 4, 3, Group Ganglion Block 3, 4, 4, Cinnarizine 4, 4, 1, Group Ganglion Block 4, 4, 2, Group Ganglion Block 4, 4, 3, Cinnarizine 4, 4, 4, Cinnarizine 5, 4, 1, Cinnarizine 5, 4, 2, Cinnarizine 5, 4, 3, Group Ganglion Block 5, 4, 4, Group Ganglion Block 6, 4, 1, Cinnarizine 6, 4, 2, Group Ganglion Block 6, 4, 3, Cinnarizine 6, 4, 4, Group Ganglion Block 7, 4, 1, Group Ganglion Block 7, 4, 2, Group Ganglion Block 7, 4, 3, Cinnarizine 7, 4, 4, Cinnarizine 8, 4, 1, Cinnarizine 8, 4, 2, Group Ganglion Block 8, 4, 3, Cinnarizine 8, 4, 4, Group Ganglion Block 9, 4, 1, Cinnarizine 9, 4, 2, Group Ganglion Block 9, 4, 3, Cinnarizine 9, 4, 4, Group Ganglion Block 10, 4, 1, Group Ganglion Block 10, 4, 2, Cinnarizine 10, 4, 3, Cinnarizine 10, 4, 4, Group Ganglion Block 11, 4, 1, Cinnarizine 11, 4, 2, Group Ganglion Block 11, 4, 3, Group Ganglion Block 11, 4, 4, Cinnarizine 12, 4, 1, Group Ganglion Block 12, 4, 2, Group Ganglion Block 12, 4, 3, Cinnarizine 12, 4, 4, Cinnarizine 13, 4, 1, Group Ganglion Block 13, 4, 2, Cinnarizine 13, 4, 3, Group Ganglion Block 13, 4, 4, Cinnarizine, Blinding description: The person evaluating the improvement of tinnitus after treatment will not be aware of the type of treatment performed on the patient, and blinding will be done in a single blind. N/A Tinnitus. Intervention 1: Intervention group: There are patients who, after checking the sensory and motor nerves, in order to prevent nerve damage, and after choosing the correct location, which is basically in the roots of c1, c2, c3, They are treated with a block of the superior sympathetic ganglion of the neck using a radiofrequency pulse. Intervention 2: Control group: There are patients who are treated with the drug Cinnarizine 25 twice a day. That is, with an average dose of 50 mg daily, people will be treated with medicine. 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 There is no further information
public Ali Fahimi
Bo Ali Sina Medical Education Center, Pasdaran Blvd., Mazandaran
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 3015 alifahimi2005@gmail.com Mazandaran University of Medical Sciences scientific Maryam Daneshian
Bo Ali Sina Medical Education Center, Pasdaran Blvd., Mazandaran
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 3014 mdaneshian@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with Tinnitus without response to drug treatment Patients who have been examined neurologically and do not have neurological problem People who are over 18 years old 18 years 65 years Both Taking drugs that cause tinnitus, such as: Aminoglycosides and Loop diuretics People with known neurological diseases such as MS Patients with coagulation disorders or the use of anticoagulant drugs Patients who in addition to tinnitus, have neck injuries, especially in the C2 region, and other neck problems such as cervical spinal canal stenosis. Lack of patient satisfaction and cooperation H93.19 Tinnitus, unspecified ear Treatment - Surgery Treatment - Drugs Intervention group: There are patients who, after checking the sensory and motor nerves, in order to prevent nerve damage, and after choosing the correct location, which is basically in the roots of c1, c2, c3, They are treated with a block of the superior sympathetic ganglion of the neck using a radiofrequency pulse Control group: There are patients who are treated with the drug Cinnarizine 25 twice a day. That is, with an average dose of 50 mg daily, people will be treated with medicine. Improvement in tinnitus. Timepoint: One week, one month, 3, 6, 12, 18 and 24 months (within two years) after the procedure. Method of measurement: Patients will rate the degree of improvement of tinnitus using a scoring questionnaire from 0 to 10. Nausea - vomiting. Timepoint: Immediately after the operation - 3 hours later 6, 12 and 24 hours after the operation - one week later. Method of measurement: Examination and expression by the patient. Bleeding in the operation area. Timepoint: during the operation, 1hour , 6, 12, 24 hours after the operation. Method of measurement: Examination and observation by a doctor. Mazandaran University of Medical Sciences Approved 2023-11-06 Ethics Committee of Mazandaran University of Medical Sciences Mazandaran University of Medical Sciences and Health Care Services Building No. 2 , Moalem Square, Sari Sari Mazandaran Iran (Islamic Republic of)