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IRCT2014042417413N1 IRCT 2014-05-08 Baqiyatallah University of Medical Sciences, Deputy of Research Comparison of the therapeutic Effect of Radiofrequency and Intranasal Corticosteroid in Patients with Inferior Turbinate Hypertrophy due to Allergic Rhinitis 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 2013-06-22 anticipated 60 Complete https://irct.ir/trial/16016 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A allergic rhinitis. Intervention 1: 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). Intervention 2: Fluticasone 125 mcg intranasal spray, twice a day and every time one puff in each side of the nose. http://thritajournal.com/?page=article&article_id=19532 Background: Inferior turbinate hypertrophy (ITH) is one of the common causes of nasal obstruction. In some case with ITH due to allergic rhinitis medical therapy can be useful and in cases with refractory ITH surgical techniques may be helpful. Although there is no excellence [or superiority] among these surgical methods, radiofrequency (RF) has recently become popular.<br /> Objectives: This study compared the therapeutic effects of intranasal corticosteroid and RF in patients with ITH due to allergic rhinitis.<br /> Patients and Methods: In this randomized clinical trial, patients with ITH due to allergic rhinitis, referred to Baqiyatallah University of Medical Sciences Allergy Clinic, were randomly assigned to RF and intranasal corticosteroid spray groups (fluticasone 125 µg). Patients were evaluated by the symptoms severity, which were measured by visual analogue scale (0-10 score) and rhinomanometry, four times (before the intervention and the 1st, 3rd and 6th month after the intervention). Data were analyzed by SPSS version 21.<br /> Results: Sixty patients with ITH due to allergic rhinitis were evaluated, among which 26 were male and 34 were female. The mean age was 35.5 ± 8.86 years old and the mean body mass index (BMI) was 22.97 ± 3.12 kg/m2. There was no significant difference in demographic data among the groups. All the patients showed significant improvements in symptoms severities and rhinomanometry at all the after intervention visits. The best results were obtained in the 6th month of follow-up. The mean nasal obstruction severity and rhinomanometry results were significantly higher in the RF group at all the after intervention visits (P < 0.05).<br /> Conclusions: According to the results, we suggest using RF technique for patients with ITH due to allergic rhinitis, which is an outpatient procedure with local anesthesia; long-term effects of these two therapeutic methods (corticosteroid an RF) could be evaluated in future studies.
public Hamidreza Karimi Sari
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
Tehran Iran (Islamic Republic of) +98 21 8126 4354 dr.karimih@yahoo.com Students’ Research Committee (SRC), Baqiyatallah University of Medical Sciences, Tehran, IR Iran scientific Abolfazl Taheri
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
Tehran Iran (Islamic Republic of) +98 21 8126 4354 dr.abolfazl.taheri@gmail.com Department of ENT, Baqiyatallah University of Medical Sciences, Tehran, Iran Iran (Islamic Republic of) 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 no limit no limit Both J30 Vasomotor and allergic rhinitis Treatment - Surgery Treatment - Drugs 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) Fluticasone 125 mcg intranasal spray, twice a day and every time one puff in each side of the nose Rhinorrhea severity. Timepoint: Before treatment and one, three, and six months after intervention. Method of measurement: visual analogue score (0-10). Itchy nose severity. Timepoint: Before treatment and one, three, and six months after intervention. Method of measurement: visual analogue score (0-10). Nasal obstruction severity. Timepoint: Before treatment and one, three, and six months after intervention. Method of measurement: visual analogue score (0-10). Facial pain severity. Timepoint: Before treatment and one, three, and six months after intervention. Method of measurement: visual analogue score (0-10). Nasal airflow. Timepoint: Before treatment and one, three, and six months after intervention. Method of measurement: Rhinomanometry. Quality of life. Timepoint: Before treatment and one, three, and six months after intervention. Method of measurement: Rhino-conjunctivitis quality of life questionnaire (RQLQ). Baqiyatallah University of Medical Sciences, Deputy of Research Approved 2014-01-05 Baqiyatallah University of Medical Sciences Ethics Committee Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran. Tehran Iran (Islamic Republic of)