Protocol summary

Summary
This study is designed to assess the effects of radiofrequency and compares it with nasal corticosteroid spray in a 6-month follow-up. Ninety allergic rhinitis patients with inferior turbinate hypertrophy (ITH), referred to Baqiyatallah University of Medical Sciences Allergy Clinic will be enrolled to the study. Allergic rhinitis approves by clinical examination, history, and diagnostic tests such as rhinomanometry. Patients with other obstruction lesions, severe septal deviation, asthma, cigarette smoking, chronic rhino-sinusitis, history of other medical therapies, and history of sinus and nasal surgeries will be excluded. Patients will be randomized to radiofrequency (RF) and intranasal corticosteroid (INS) groups. Radiofrequency performs under local anesthesia with lidocaine 10% in three point of inferior turbinate two punctures in every points. (first point in front of inferior turbinate and parallel to septum, second point parallel to palmistry, and third point 2 cm posterior to other two points) The total dose of RF is 1500 joules (300 - 359 joules in each step). After procedure, patients will discharge immediately without any limitation in daily activities. For INS group Fluticasone 125 mcg intranasal spray will be prescribed twice a day and every time one puff in each side of the nose. Patients will be evaluated by rhinoscopy, symptoms (nasal obstruction, rhinorrhea, itchy nose, sneezing, caught, and facial pain) severity score (0-10 VAS score), rhinomanometry tests, and quality of life at first, third and sixth months after intervention. Collected data will be compared in two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014042417413N1
Registration date: 2014-05-08, 1393/02/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-05-08, 1393/02/18
Registrant information
Name
Hamidreza Karimi-Sari
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 4354
Email address
hrkarimisari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences, Deputy of Research.
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial of Comparison of Radiofrequency and Intranasal Corticosteroid Efficacies on Rhinomanometry, Symptom Severity, and Quality of Life in Patients With Inferior Turbinate Hypertrophy Due to Allergic Rhinitis
Public title
Comparison of the therapeutic Effect of Radiofrequency and Intranasal Corticosteroid in Patients with Inferior Turbinate Hypertrophy due to Allergic Rhinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Allergic rhinitis patients with inferior turbinate hypertrophy referred to Baqiyatallah University of Medical Sciences Allergy Clinic without any age and gender limitations. Exclusion criteria: Patients with other obstruction lesions (e.g. polyp and tumor); severe septal deviation; asthma; cigarette smoking; chronic rhino-sinusitis; history of other medical therapies; history of sinus and nasal surgeries
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Sciences Ethics Committee
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Postal code
Approval date
2014-01-05, 1392/10/15
Ethics committee reference number
34-15

Health conditions studied

1

Description of health condition studied
allergic rhinitis
ICD-10 code
J30
ICD-10 code description
Vasomotor and allergic rhinitis

Primary outcomes

1

Description
Rhinorrhea severity
Timepoint
Before treatment and one, three, and six months after intervention
Method of measurement
visual analogue score (0-10)

2

Description
Itchy nose severity
Timepoint
Before treatment and one, three, and six months after intervention
Method of measurement
visual analogue score (0-10)

3

Description
Nasal obstruction severity
Timepoint
Before treatment and one, three, and six months after intervention
Method of measurement
visual analogue score (0-10)

4

Description
Facial pain severity
Timepoint
Before treatment and one, three, and six months after intervention
Method of measurement
visual analogue score (0-10)

5

Description
Nasal airflow
Timepoint
Before treatment and one, three, and six months after intervention
Method of measurement
Rhinomanometry

6

Description
Quality of life
Timepoint
Before treatment and one, three, and six months after intervention
Method of measurement
Rhino-conjunctivitis quality of life questionnaire (RQLQ)

Secondary outcomes

empty

Intervention groups

1

Description
Radiofrequency of inferior turbinate under local anesthesia with lidocaine 10% in three point of inferior turbinate (first point in front of inferior turbinate and parallel to septum, second point parallel to palmistry, and third point 2 cm posterior to other two points), two punctures in every points, with the total dose of 1500 ± 200 joules (300 - 359 joules in each step)
Category
Treatment - Surgery

2

Description
Fluticasone 125 mcg intranasal spray, twice a day and every time one puff in each side of the nose
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah University of Medical Sciences Polyclinic
Full name of responsible person
Hamidreza Karimi Sari
Street address
Baqiyatallah University of Medical Sciences Polyclinic, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences, Deputy of Research
Full name of responsible person
Hamidreza Zangeneh
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah University of Medical Sciences, Deputy of Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Students’ Research Committee (SRC), Baqiyatallah University of Medical Sciences, Tehran, IR Iran
Full name of responsible person
Hamidreza Karimi Sari
Position
General Practitioner
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Postal code
Phone
+98 21 8126 4354
Fax
+98 21 8126 4354
Email
dr.karimih@yahoo.com
Web page address
http://bmsusrc.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of ENT, Baqiyatallah University of Medical Sciences, Tehran, Iran
Full name of responsible person
Abolfazl Taheri
Position
Assistant Professor
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Postal code
Phone
+98 21 8126 4354
Fax
+98 21 8126 4354
Email
dr.abolfazl.taheri@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Students’ Research Committee (SRC), Baqiyatallah University of Medical Sciences (BMSU), Tehran, Iran
Full name of responsible person
Hamidreza Karimi Sari
Position
General Practitioner
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Postal code
Phone
+98 21 8126 4354
Fax
+98 21 8126 4354
Email
dr.karimih@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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