title: Treatment of idiopathic rhinitis with kinetic oscillations - a multi-centre randomized controlled study.
abstract: CONCLUSIONS
  The potential effects of KOS are still uncertain regarding the most effective air pressure to be used as well as the physiological effects on the nasal mucosa. The results of the study do not support a convincing treatment effect by KOS on IR.
  
  
  OBJECTIVE
  Idiopathic rhinitis (IR) is a common disorder, affecting ∼10-20% of the population. A new method for treating IR, Kinetic Oscillation Stimulation (KOS), has been reported to have beneficial effects on total vasomotor symptom scores (TVRSS). The primary objective with this study was to evaluate if a mean pressure of 65 mbar, pressure amplitude of 100 mbar, and 68 Hz treatment with KOS had a positive effect on total vasomotor symptom scores (TVRSS), as compared with a mean pressure of 65 mbar, pressure amplitude of 4 mbar, and 68 Hz treatment in patients with idiopathic rhinitis.
  
  
  METHODS
  Two hundred and seven patients were randomized (Full Analysis Set, FAS) in the study, including five visits and lasting for ∼25 weeks. All patients had two treatment episodes, and all patients had at least one treatment, meant as active, with high amplitude pressure for 10 min in each nostril. Group 1 had two such treatments, and Group 2 had one treatment with low amplitude pressure, initially meant as placebo, on one occasion. Because of numerical improvements in these two groups, a new control group, Group 3, was introduced. They had one new control treatment where the balloon was inserted into the nose, without any air inflation and without oscillations.
  
  
  RESULTS
  KOS treatment with high amplitude pressure did not have significant beneficial effects as compared to low amplitude pressure on TVRSS. Numerical improvements in TVRSS and SNOT 22 were found when comparing high and low amplitude pressure treatments with uninflated balloon treatment. However, this part of the study was initially single-blinded, and these results were secondary objectives.
authors.affiliation: a Department of Clinical Science, Intervention and Technology, Division of Otorhinolaryngology , Karolinska Institutet , Stockholm , Sweden ;
authors.forename: Anders
authors.initials: A
authors.lastname: Ehnhage
authors.affiliation: b Department of Otorhinolaryngology, Head and Neck Surgery , Skåne University Hospital , Lund and Malmö , Sweden ;
authors.forename: Pernilla Sahlstrand
authors.initials: PS
authors.lastname: Johnsson
authors.affiliation: b Department of Otorhinolaryngology, Head and Neck Surgery , Skåne University Hospital , Lund and Malmö , Sweden ;
authors.forename: Cecilia
authors.initials: C
authors.lastname: Ahlström-Emanuelsson
authors.affiliation: b Department of Otorhinolaryngology, Head and Neck Surgery , Skåne University Hospital , Lund and Malmö , Sweden ;
authors.forename: Morgan
authors.initials: M
authors.lastname: Andersson
authors.affiliation: c Department of Otorhinolaryngology , Centre for Clinical Research Västmanland Hospital , Västerås , Sweden ;
authors.forename: Johan
authors.initials: J
authors.lastname: Knutsson
authors.affiliation: a Department of Clinical Science, Intervention and Technology, Division of Otorhinolaryngology , Karolinska Institutet , Stockholm , Sweden ;
authors.forename: Jacob
authors.initials: J
authors.lastname: Lien
authors.affiliation: d Aleris Sabbatsbergs Hospital , Stockholm , Sweden ;
authors.forename: Tomas
authors.initials: T
authors.lastname: Norlander
authors.affiliation: a Department of Clinical Science, Intervention and Technology, Division of Otorhinolaryngology , Karolinska Institutet , Stockholm , Sweden ;
authors.forename: Petter
authors.initials: P
authors.lastname: Olsson
authors.affiliation: e Friis-Liby and Rönndahl ENT Practice , Göteborg , Sweden.
authors.forename: Jan-Eric
authors.initials: JE
authors.lastname: Friis-Liby
authors.affiliation: a Department of Clinical Science, Intervention and Technology, Division of Otorhinolaryngology , Karolinska Institutet , Stockholm , Sweden ;
authors.forename: Mats
authors.initials: M
authors.lastname: Holmström
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011312:Pressure; D012220:Rhinitis / Q000628:therapy; D012223:Rhinitis, Vasomotor / Q000628:therapy*; D055815:Young Adult
keywords: KOS; Vasomotor rhinitis; nasal congestion; nasal obstruction; non-allergic rhinitis