Randomized Controlled Trial Examining the Effects of Balloon Catheter Dilation on “Sinus Pressure” / Barometric Headaches

Abstract

Objective

To determine if balloon catheter dilation of sinus ostia affects the severity or frequency of headache among patients who have barometric pressure–related “sinus” headache.

Study Design

Prospective single-blinded randomized controlled trial.

Setting

Tertiary care medical center.

Subjects and Methods

Subjects with a diagnosis of sinus pressure headache without evidence of mucosal thickening on computed tomography were recruited. Subjects were blinded and randomized to undergo balloon dilation of affected sinus ostia (active treatment) or balloon dilation in the nasal cavity (placebo). Two balloon devices were utilized (Acclarent and Entellus) and outcomes compared. Subjects were followed with pre- and postprocedure SNOT-22 scores (Sinonasal Outcome Test–22), HIT-6 scores (Headache Impact Test–6), and medication utilization logs for 6 months.

Results

There was no statistically significant difference in SNOT-22 or HIT-6 scores between the arms at any time point. However, both arms experienced statistically and clinically significant decreases in SNOT-22 and HIT-6 scores from preprocedure to 6 months postprocedure. There was no statistically significant difference in SNOT-22 or HIT-6 score reductions between the Entellus and Acclarent devices. There was no statistically significant difference in medication utilization between the groups at any time point.

Conclusions

Subjects with sinus pressure headache without evidence of mucosal thickening on computed tomography had no significant difference in outcomes between active treatment (balloon dilation of sinus ostia) and placebo (nasal dilation). Further study on the etiology and effective treatment of barometric pressure / “sinus” headache is needed.