Investigating the effectiveness of intratympanic injection of lidocaine and dexamethasone separately in the treatment of idiopathic tinnitus in Loghman hospital in 1403
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General information
Due to the increase in accuracy and lack of bias in the results, the study is conducted in a triple-blinded manner.
The start date of patient entry was entered (June 26, 2024)
The update is to inform about the completion process and progress of the study.
The number of entry patients every month is recorded in the update, and in the study results section, the patients whose information has been completed in the previous months (including the final entry and exit or adverse events) are recorded.
In the month of October, we had 19 patients entering the study, and the information of the July patients, which is related to the previous 3 months, was recorded in the study results section (because the follow-up is 3 months and the final results are determined every month after 3 months).
DueThe update is to inform about the completion process and progress of the study. The number of entry patients every month is recorded in the update, and in the study results section, the patients whose information has been completed in the previous months (including the final entry and exit or adverse events) are recorded. In the month of October, we had 19 patients entering the study, and the information of the July patients, which is related to the increase in accuracy and lack of biasprevious 3 months, was recorded in the study results, section (because the studyfollow-up is conducted in a triple-blinded manner3 months and the final results are determined every month after 3 months). The start date of patient entry was entered (June 26, 2024)
به علت افزایش دقت و عدم سوگیری در نتایج, مطالعه به صورت سه کور انجام می شود.
تاریخ شروع بیمارگیری درج شد (1 خرداد 1403)
بروز رسانی جهت اطلاع از روند تکمیل و سیر اجرای مطالعه می باشد.
تعداد بیماران ورودی در هر ماه در به روز رسانی ثبت می شود و در قسمت نتایج مطالعه, بیمارانی که در ماه های قبل اطلاعات انها تکیمل شده است (شامل ورودی و خروجی نهایی و یا رخدادهای نامطلوب ثبت می شود.
در ماه مهر ۱۹ بیمار ورودی به مطالعه داشتیم و اطلاعات بیماران تیر ماه که مربوط به ۳ ماه قبل است در قسمت نتایج مطالعه ثبت شد ( چون پیگیری ها ۳ ماه است و نتایج نهایی هر ماه بعد از ۳ ماه مشخص میشود)
به علت افزایش دقتبروز رسانی جهت اطلاع از روند تکمیل و عدم سوگیریسیر اجرای مطالعه می باشد. تعداد بیماران ورودی در نتایج, مطالعههر ماه در به صورت سه کور انجامروز رسانی ثبت می شود و در قسمت نتایج مطالعه, بیمارانی که در ماه های قبل اطلاعات انها تکیمل شده است (شامل ورودی و خروجی نهایی و یا رخدادهای نامطلوب ثبت می شود. تاریخ شروع بیمارگیری درجدر ماه مهر ۱۹ بیمار ورودی به مطالعه داشتیم و اطلاعات بیماران تیر ماه که مربوط به ۳ ماه قبل است در قسمت نتایج مطالعه ثبت شد (1 خرداد 1403 چون پیگیری ها ۳ ماه است و نتایج نهایی هر ماه بعد از ۳ ماه مشخص میشود)
Trial results
may/ june
june/ july
july/ august
august/ september
september/october
patient entry
17
15
21
14
patient exclusion
2
final patients
15
Adverse event
1
may/ june
june/ july
july/ august
august/ september
september/october
patient entry
17
15
21
14
19
patient exclusion
2
2
final patients
15
13
Adverse event
1
0
may/ june
june/ july
july/ august
august/ september
september/october
patient entry
17
15
21
14
19
patient exclusion
2
2
final patients
15
13
Adverse event
1
0
خرداد
تیر
مرداد
شهریور
بیماران وارد شده
۱۷
۱۵
۲۱
۱۴
بیماران خارج شده
۲
تعداد نهایی
۱۵
رخداد نامطلوب
۱
خرداد
تیر
مرداد
شهریور
مهر
بیماران وارد شده
۱۷
۱۵
۲۱
۱۴
۱۹
بیماران خارج شده
۲
۲
تعداد نهایی
۱۵
۱۳
رخداد نامطلوب
۱
۰
خرداد
تیر
مرداد
شهریور
مهر
بیماران وارد شده
۱۷
۱۵
۲۱
۱۴
۱۹
بیماران خارج شده
۲
۲
تعداد نهایی
۱۵
۱۳
رخداد نامطلوب
۱
۰
Protocol summary
Study aim
Investigating the effectiveness of intratympanic injection of lidocaine and dexamethasone separately in the treatment of idiopathic tinnitus in Loghman hospital in 2024
Design
A double-blind randomized clinical trial with a control group, with 3 parallel groups, phase 3 on 120 patients, randomization using shuffling cards.The study conducts in 1403
Settings and conduct
The study was conducted in loghman Hospital in 2024 in eligible patients with idiopathic tinnitus. After randomizing the patients by shuffling cards, the patients are divided in 3 groups of lidocaine, dexamethasone and saline injection. The audiogram and the tinnitus handicap inventory are completed and the injections are done 4 times during 2 weeks (2 injections every week with an interval of 3 days) under the microscope and the results are evaluated.
injections are done by doctor.
In this study, blinding of the participant and the clinical caregiver is done, and they don't know the type of injectable substance.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with tinnitus referred to loghman Hospital in 2024; patients whose tinnitus cause cannot be found; patients who don't have concomitant ear disorders.
Exclusion criteria: patients who exit the study for any reason during the research; patients who don't complete study follow up.
Intervention groups
The study consists of 3 groups of 40 people
In each 3 groups, injections are done 4 times during 2 weeks (2 injections every week with an interval of 3 days) under the microscope.
First group: intratympanic injection of dexamethasone.
Second group: intratympanic injection of lidocaine
third group: intratympanic injection of saline
The first and second groups are intervention groups and the third group is control group.
The update is to inform about the completion process and progress of the study.
The number of entry patients every month is recorded in the update, and in the study results section, the patients whose information has been completed in the previous months (including the final entry and exit or adverse events) are recorded.
In the month of October, we had 19 patients entering the study, and the information of the July patients, which is related to the previous 3 months, was recorded in the study results section (because the follow-up is 3 months and the final results are determined every month after 3 months).
Acronym
IRCT registration information
IRCT registration number:IRCT20240420061531N1
Registration date:2024-05-17, 1403/02/28
Registration timing:prospective
Last update:2024-10-31, 1403/08/10
Update count:11
Registration date
2024-05-17, 1403/02/28
Registrant information
Name
Ghaem Khodabakhsh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3337 9872
Email address
ghaemkhodabakhsh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of intratympanic injection of lidocaine and dexamethasone separately in the treatment of idiopathic tinnitus in Loghman hospital in 1403
Public title
Investigating the effectiveness of intratympanic injection of lidocaine and dexamethasone separately in the treatment of idiopathic tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with tinnitus referred to Luqman educational-therapeutic-research center in 2024
Patients who cannot find a cause for their tinnitus
Patients who include tinnitus and without concomitant disease such as rupture of the eardrum, a history of ear surgery, otosclerosis, Cerebellopontine angle tumor, ear trauma, disorders of internal systems such as hypothyroidism,Monocular hearing, diabetes and genetic disorders.
Exclusion criteria:
Patients who are excluded from the study for any reason during the research or follow-up is not possible.
Patients who do not complete the full follow-up of the study (follow-up within 3 months).
Patients who are excluded from the study due to possible complications.
Age
No age limit
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In general, simple randomization of people by the method of shuffling cards
+ Description of the randomization process:
The process of generating a random sequence will be done in the form of simple randomization and through the preparation and shuffling of cards. So that a number of cards will be prepared as the first group and the same number of cards will be prepared for the next groups. Then, by removing them, a card is taken out and its allocation is recorded, and that card is returned to the other cards. Then the cards are dealt again and so on
Another card is taken out. This process will continue until reaching a random sequence according to the sample size.
Concealment of random allocation will be done by placing the mentioned cards inside sealed opaque envelopes. People from the research team who are responsible for the above steps enter other steps
The research, especially the examination and analysis of people in terms of the dependent variable, will not be done (for blinding).
Blinding (investigator's opinion)
Triple blinded
Blinding description
To blind the participants, the method of flipping cards is used. Patients choose from sealed cards and enter one of 3 intratympanic injection categories.
Also, the people who are responsible for intratympanic injection (clinical caregivers) only perform intratympanic injection and do not know the nature of the injected substance.
Also, the researchers who are in charge of analyzing and completing the tinnitus forms and questionnaire are also not aware of the type of injectable substance.
Placebo
Used
Assignment
Parallel
Other design features
The side effects of intratympanic injection, which is one of the limiting factors of this method, are carefully examined. For example, in recent studies, lidocaine injection has a low but significant effect, but its use is limited due to severe vertigo.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Volanjek, Student Blvd, Koodac yar street, tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-04-09, 1403/01/21
Ethics committee reference number
IR.SBMU.MSP.REC.1403.018
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
Tinnitus reduction in tinnitus handicap inventory (6 to 8 marks)
Timepoint
In the period of the first 2 weeks after the injections and 1 month and 3 months later. First, before the start of the injections, at the beginning of the study, then at the end of 2 weeks, 1 month and 3 months. It is measured 4 times overall.
Method of measurement
THI (tinnitus handicap inventory) questionnaire to measure tinnitus. Tinnitus handicap inventory is a 25-item questionnaire to determine the severity of tinnitus disability, which psychometrics have been proven in studies. The 25 items of the questionnaire are classified into three functional, emotional and catastrophic subscales.
Secondary outcomes
1
Description
Tympanic membrane perforation
Timepoint
In the first 2 weeks and 3 months later. It is checked twice in the study
Method of measurement
Examination under the microscope
2
Description
Hearing loss
Timepoint
In the first 2 weeks and 3 months later. It is checked twice in the study
Method of measurement
Audiogram
Intervention groups
1
Description
intervention group: intratympanic injection of dexamethasone. In the first intervention group, which is a group of 40 people, they are subjected to intratympanic injection of dexamethasone 4 times during two weeks (2 injections every week with a time interval of 3 days). First, patients are given a short explanation about the number of sessions and how to inject the substance and the side effects and consequences. The injection equipment includes a 2 cc syringe, a pink angiocatheter, cotton and a vial of injectable material.The equipment is provided by the researcher and the patient does not pay for it. The injection is performed by the doctor under the microscope and in the postero-inferior area of the tympanic membrane (near the round window). Dexamethasone is manufactured by IranHormon Pharmaceutical Company, which contains 8 mg of dexamethasone in 2 cc vials. The injection volume is 1 cc per session which is equivalent to 4 mg of dexamethasone (the middle ear volume in an adult human is an average 0.5 to 1 cc)
Category
Treatment - Drugs
2
Description
Intervention group: intratympanic injection of lidocaine. In the second intervention group, which also includes a group of 40 people, intratympanic injection of lidocaine was performed 4 times during two weeks (2 injections every week with a time interval of 3 days). First, patients are given a short explanation about the number of sessions and how to inject the substance and the side effects and consequences. The injection equipment includes a 2 cc syringe, a pink angiocatheter, cotton and a vial of injectable material.The equipment is provided by the researcher and the patient does not pay for it. The injection is performed by the doctor under the microscope and in the posterior lower area of the eardrum (near the round window). Lidocaine is manufactured by IranHormon Pharmaceutical Company, which contains 5 cc vials containing 100 mg of lidocaine. The injection volume is 1 cc per session, which is equivalent to 20 mg of lidocaine (the middle ear space in an adult human is on average 0.5 to 1 cc)
Category
Treatment - Drugs
3
Description
Control group: intratympanic injection of saline. In the third group, which is the control group of the study, there are also 40 people and intratympanic injection of sterile saline is done 4 times during two weeks (2 injections every week with a time interval of 3 days). First, patients are given a short explanation about the number of sessions and how to inject the substance and the side effects and consequences. The injection equipment includes a 2 cc syringe, a pink angiocatheter, cotton and a vial of injectable material. The equipment is provided by the researcher and the patient does not pay for it. The injection is performed by the doctor under the microscope and in the posterior lower area of the eardrum (near the round valve). The injection volume is 1 cc of sterile saline per session (the middle ear space in an adult human is on average 0.5 to 1 cc)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Ghaem Khodabakhsh
Street address
Luqman Hakim hospital, Lashgar intersection
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
loghman.hospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
5th floor, Building No. 2, Yemen St., Shahid Arabi St., Shahid Chamran highway, tehran
City
Tehran
Province
Tehran
Postal code
193954719
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ghaem Khodabakhsh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Luqman Hakim hospita, Lashgar intersection of special street
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
ghaemkhodabakhsh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ghaem Khodabakhsh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Luqman Hakim hospital, Lashgar intersection of special street
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
ghaemkhodabakhsh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ghaem Khodabakhsh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Luqman Hakim hospital, Lashgar intersection of special street
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
ghaemkhodabakhsh@yahoo.com
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data related to people is most likely to be published after anonymizing them with details related to variables, etc
When the data will become available and for how long
After the end of the study and review and analysis of the data and the publication of the study, which will probably be in the middle of 1404
To whom data/document is available
Academic and scientific institutions
Other people's access is not allowed
Under which criteria data/document could be used
For use in the treatment of patients and analysis to draw conclusions about the effect of drug injections
Comparing the effects of 3 types of injected substances and checking variables such as age and sex, duration of tinnitus onset, etc. is allowed
From where data/document is obtainable
to the research assistant of Shahid Beheshti University of Medical Sciences
What processes are involved for a request to access data/document
After the verification of the scientific degree of the person or the organization by the university, the information is provided to the person or the organization