Determining the effect of cryotherapy of the posterior nasal nerve on the treatment of patients with rhinitis
Design
A clinical trial with single group comparing symptoms before and after cryotherapy of the posterior nasal nerve in 40 eligible patients with rhinitis.
Settings and conduct
Fourty eligible patients referred to the ENT clinic of Baqiyatallah Hospital will be selected and the symptoms will be registered in 4 categories of absence, mild, moderate and severe according to the TNSS scoring system. After performing cryotherapy of PNN endoscopically using a cryonasal device, the researcher again will record the symptoms of the patients after performing cryotherapy at time intervals of 7 days later, one month later, three months later and six months later, using the TNSS scoring system.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age above 18 years old; Diagnosis of rhinitis (allergic, non-allergic or a combination of both) by an ENT specialist; Failure to respond to treatment with conventional medical drugs for at least 3 months.
Non-inclusion criteria: Patients with acute or chronic sinusitis; Medicinal rhinitis (medicamentosa); Presence of CSF rhinorrhea; Systemic diseases involving the sinonasal area.
Intervention groups
Performing cryotherapy of the posterior nasal nerve in patients with rhinitis who have not responded to treatment with conventional drugs.
Main outcome variables
Improving the symptoms of rhinitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220421054606N1
Registration date:2023-05-03, 1402/02/13
Registration timing:prospective
Last update:2023-05-03, 1402/02/13
Update count:0
Registration date
2023-05-03, 1402/02/13
Registrant information
Name
Hossein Eshraghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4022 6102
Email address
hossein.eshraghi313@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of cryotherapy (cryoablation) of posterior nasal nerve on the treatment of patients with rhinitis
Public title
Effect of cryotherapy (cryoablation) of posterior nasal nerve on rhinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years
The diagnosis of rhinitis (allergic, non-allergic or a combination of both) was made by an ENT specialist based on history and examinations.
Failure to respond to treatment with conventional medical drugs for at least 3 months
Exclusion criteria:
Patients with acute or chronic sinusitis
Medicinal rhinitis (medicamentosa)
Cerebrospinal fluid leakage in the form of CSF rhinorrhea
Systemic diseases involving the sinonasal such as: granulomatous polyangiitis (Wegener), Sjögren's, cystic fibrosis (CF), primary ciliary movement disorder (PCD)
History of frequent epistaxis, pregnancy and coagulation disorders
Evidence of benign or malignant sinonasal neoplasms
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah Hospital; Azam dead end alley; South Sheikh Bahai street
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2022-10-03, 1401/07/11
Ethics committee reference number
IR.BMSU.BAQ.REC.1401.047
Health conditions studied
1
Description of health condition studied
Allergic or non-allergic rhinitis or a combination of both
ICD-10 code
J30
ICD-10 code description
Vasomotor and allergic rhinitis
Primary outcomes
1
Description
Score of rhinitis symptoms based on TNSS (Total Nasal Symptom Score) questionnaire
Timepoint
Recording the severity of rhinitis symptoms at the beginning of the study (before the start of cryotherapy) and 7 days later, one month later, three months later and six months after cryotherapy of the posterior nasal nerve.
Method of measurement
TNSS (Total Nasal Symptom Score) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In patients with rhinitis who are over 18 years old and have not responded to conventional medical treatments for at least 3 months, in the clinic environment, under local anesthesia and during nasal endoscopy, cryotherapy (cryoablation) of the posterior nasal nerve by Cryonasal device is performed for them.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
ENT Clinic of Baqiyatallah Hospital
Full name of responsible person
Mohsen Saberi Isfeedvajani
Street address
Baqiyatallah Hospital; Azam dead end alley; South Sheikh Bahai street
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hossein Eshraghi
Position
ENT Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No. 2, Unit 16, 4th Floor, Shohadaye-Gomnam street., Shahid Mahallati Town
City
Tehran
Province
Tehran
Postal code
1955757608
Phone
+98 21 4022 6102
Fax
Email
hossein.eshraghi313@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hossein Eshraghi
Position
ENT Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No. 2, Unit 16, 4th Floor, Shohadaye-Gomnam street., Shahid Mahallati Town
City
Tehran
Province
Tehran
Postal code
1955757608
Phone
+98 21 4022 6102
Fax
Email
hossein.eshraghi313@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hossein Eshraghi
Position
ENT Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No. 2, Unit 16, 4th Floor, Shohadaye-Gomnam street., Shahid Mahallati Town
City
Tehran
Province
Tehran
Postal code
1955757608
Phone
+98 21 4022 6102
Fax
Email
hossein.eshraghi313@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In this study, the data related to the main outcome (scoring of rhinitis symptoms based on the TNSS questionnaire before and after performing Cryotherapy) can be shared after de-identifying the subjects.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Study data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
It is possible to use the data and documents to conduct additional research related to the title of the study, provided the source and the names of the researchers of this study are mentioned.
From where data/document is obtainable
To receive study data and documents, they can send their request to the following email:
Hossein.eshraghi313@gmail.com
What processes are involved for a request to access data/document
To receive study data and documents, they can send their request to the following email:
Hossein.eshraghi313@gmail.com
After sending an email and checking their request by the study researchers, if there is no problem, we will try to provide them with the data in a short period of time.