Protocol summary

Study aim
Determining the effect of superior cervical sympathetic ganglion block using radiofrequency in the treatment of patients with Tinnitus
Design
This clinical trial has two control and intervention groups, with parallel groups, one-blind, randomized, on 40 patients.
Settings and conduct
Patients are included in the study based on the entry and exit criteria and after obtaining written consent. They are divided into two groups. the control group, which is treated with Cinnarizine, and the intervention group, which was previously treated with Cinnarizine, but did not respond to the treatment, and will now be treated with Radiofrequency. All patients are subjected to superior cervical sympathetic ganglion block by a specialist doctor in completely sterile conditions. One week, one month, 3, 6, 12, 18 and 24 months (within two years) after the procedure, patients will be examined in person at the clinic. 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 one-way blind. The place of the study is Bo-Ali Sina Medical Education Center, Sari.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People who are over 18 years old Patients with Tinnitus without response to drug treatment Patients who have been examined neurologically and do not have neurological problem Exit criteria: People with known neurological diseases such as MS Patient with coagulation disorders or use of anticoagulants
Intervention groups
Intervention group: Patients with Radiofrequency treatment on superior cervical sympathetic ganglion block Control group: Patients treated with cinnarizine drug
Main outcome variables
Nausea - vomiting / bleeding in the operation area

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231113060043N1
Registration date: 2023-12-23, 1402/10/02
Registration timing: registered_while_recruiting

Last update: 2023-12-23, 1402/10/02
Update count: 0
Registration date
2023-12-23, 1402/10/02
Registrant information
Name
maryam daneshian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4203 5804
Email address
daneshian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-19, 1402/08/28
Expected recruitment end date
2024-01-18, 1402/10/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of superior cervical sympathetic ganglion block using radiofrequency in the treatment of adult patients with tinnitus
Public title
The effect of superior cervical sympathetic ganglion block using radiofrequency in the treatment of tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences and Health Care Services Building No. 2 , Moalem Square, Sari
City
Sari
Province
Mazandaran
Postal code
4817844718
Approval date
2023-11-06, 1402/08/15
Ethics committee reference number
IR.MAZUMS.REC.1402.444

Health conditions studied

1

Description of health condition studied
Tinnitus
ICD-10 code
H93.19
ICD-10 code description
Tinnitus, unspecified ear

Primary outcomes

1

Description
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

Secondary outcomes

1

Description
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

2

Description
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

Intervention groups

1

Description
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
Category
Treatment - Surgery

2

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Bo Ali Sina Hospital, Sari
Full name of responsible person
Maryam Daneshian
Street address
Bo Ali Sina Medical Education Center, Pasdaran Blvd., Mazandaran,
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3015
Email
daneshian@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Alia Zamani Kiasari
Street address
Mazandaran University of Medical Sciences, Serah Joibar, Imam Square, Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4104
Fax
+98 11 3530 2527
Email
refah@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ali Fahimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Bo Ali Sina Medical Education Center, Pasdaran Blvd., Mazandaran
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3015
Email
alifahimi2005@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Maryam Daneshian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bo Ali Sina Medical Education Center, Pasdaran Blvd., Mazandaran
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3014
Email
mdaneshian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ali Abbaskhani Davanlu
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bo Ali Sina Medical Education Center, Pasdaran Blvd., Mazandaran
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3010
Email
a.abbaskhani@mazums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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