Conclusion: Patient self-administration of the Kinetic Oscillatory Stimulation (KOS)-catheter was a fully acceptable alternative to insertion of the catheter by physician with helmet fixation, in patients with non-allergic rhinitis (NAR). The approaches were equivalent regarding pain. The treatment effect in the patient self-administration group was not inferior.
Objectives: To evaluate whether self-administration of a KOS-catheter was different compared to insertion by a physician, assessed with patient reported pain on a visual analogue scale (VAS). Also, to evaluate the difference in nasal stuffiness with the Sino-Nasal Outcome Test (SNOT-22) and Peak Nasal Inspiratory Flow (PNIF).
Methods: Patients with NAR were randomized to group 1, patient insertion of catheter and manual fixation, and group 2, catheter insertion by physician and fixation with a helmet. Patients were treated once, 10 min in each nasal cavity, and followed up 14 days later.
Results: Twenty-nine patients were included (group 1, n = 14; group 2, n = 15). There was no statistical significant difference in patient reported pain between groups. There was a decrease in nasal stuffiness after treatment in the total study population (n = 26, p = 0.001). In group 1 nasal stuffiness was decreased and in group 2 there was no change (group 1, p = 0.004; group 2, p = 0.071). No statistical significant change in PNIF was observed.
Keywords: KOS; autonomic nervous system; idiopathic rhinitis; low frequency nerve stimulation; medical device; minimally invasive; nasal stuffiness; neuromodulation; vasomotor rhinitis.