The Effect of Early Radiofrequency Turbinate Reduction on Persistent Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary outcome of this study is to evaluate the effect of radiofrequency turbinate
      reduction as an initial treatment on clinical improvement (using visual analogue scale based
      on total nasal symptoms score, peak nasal inspiratory flow, and turbinate size using ImageJ),
      inflammatory mediators (ELISA from nasal secretions was performed to measure ECP, IL-5, and
      HSP-70), and remodeling markers (through nasal biopsy followed by immunohistochemistry
      examination to evaluate MMP-9, TIMP-1, and PAI-1).

      In this randomized, controlled trial, 32 patients with moderate-severe persistent AR were
      randomly divided into 2 groups. Intervention group received radiofrequency turbinate
      reduction followed by intranasal steroid and antihistamine H-1(AH-1), control group received
      intranasal steroid and AH-1. Both groups were evaluated for clinical improvement in week 4
      and 8 after treatment, inflammatory mediators and remodeling markers in week 4 after
      treatment.
    

Detailed description: 
      The study compares 2 groups of moderate-severe persistent allergic rhinitis (AR). The
      intervention group receives radiofrequency turbinate reduction followed by pharmacology
      treatment (intranasal steroid and AH-1) while the control group receives only pharmacology
      treatment.

      Diagnosis of AR will be made through clinical history, physical examination, and skin
      puncture test. Patients aged 18-55 years old with moderate-severe persistent AR who come to
      the outpatient clinic and have signed the informed consent form will be included in this
      study. Moderate-severe AR is defined as having AR symptoms for more than 4 days in a week and
      more than 4 weeks, with symptoms affecting the subjects' quality of life. Patients will be
      assigned to two groups of treatment randomly with a single blind block randomization.
    

Intervention name(s): Radiofrequency turbinate reduction; Pharmacology treatment
Intervention type(s): Procedure; Drug
Intervention description(s): Before the radiofrequency turbinate reduction procedure, local anaesthesia will be given by applying a cotton tamponade soaked in lidocaine adrenaline 1:5000 titration and added with xylocaine gel for 10 minutes in both nostrils. Then, a mixture of 1 mL of lidocaine 2% and 2 mL of sodium chloride 0,9% will be infiltrated to both nostrils using 3 mL and 1 mL needles until the inferior turbinates are pale. The radiofrequency probe (made by Sutter, both in monopolar and bipolar modes) will be inserted to the distal inferior turbinate until the black line from the probe is inside the inferior turbinate (approximately 10-12 mm). The procedure will be done for 10 seconds and the insertion of the probe can be done in 2-3 sites. After this, subjects from this group will be treated with pharmacology treatment using intranasal steroid and AH-1 according to ARIA WHO guideline 2008, similar to the pharmacology treatment received by the control group.; Subjects will be treated with intranasal steroid and AH-1 according to ARIA WHO guideline 2008. Fluticasone furoate will be given twice a day with two sprays (100 µg) for each nostril for 2 weeks, then continue for once a day with two sprays (100 µg). Antihistamine H-1 is given 10 mg, once a day. Pharmacology treatment is given for 4 weeks, then intranasal steroid will be continued for another 4 weeks.
Other intervention name(s): Standard treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: allergic; histamine antagonist; radiofrequency turbinate reduction; rhinitis; steroid