Treatment of sinus headache using a device that combines acoustic vibration with oscillating expiratory pressure

Abstract Objective To determine if simultaneous administration of acoustic vibration and oscillating expiratory pressure affects the severity of facial pain among patients with complaint of “sinus headache”. Methods This is a prospective single‐arm observational study performed at a tertiary care medical center. Subjects with complaint of sinus headache without evidence of chronic rhinosinusitis on exam or computed tomography participated in a clinical study applying simultaneous acoustic vibrations and positive expiratory pressure to the nasal cavity twice daily over 4 weeks. Efficacy was assessed using three validated pain metrics—pain visual analog scale (VAS), brief pain inventory‐short form (BPI‐SF), and McGill pain questionnaire‐short form (MPQ‐SF). Device safety and patient satisfaction were also assessed using questionnaires. Results Twenty‐nine patients (mean age 49 years, 55% female) completed the study without any major adverse events. At the 4 week follow‐up, facial pain VAS improved from mean ± SD of 59.6 ± 15.7 to 34.6 ± 21.7 (p < .001), BPI mean pain (mean ± standard deviation) improved from 4.4 ± 2.0 to 2.9 ± 1.9 (p = .007), and MPQ‐SF total improved from 12.2 ± 6.5 to 6.5 ± 5.2 (p < .001) with approximately 70% of patients achieving a minimal clinically important difference (MCID) across all metrics. Additionally, pain VAS was assessed 5 min after a single use at baseline with significant improvement (p < .001). Eighty‐six percent of subjects would both use device again and recommend it to others. Conclusions Simultaneous administration of acoustic vibration and oscillating expiratory pressure appears to be a safe treatment for sinus headaches in patients without objective evidence of chronic sinusitis. Results from this initial study are promising with regard to efficacy in treatment of sinus headaches but will require further study. Level of evidence 2c