Kinetic oscillatory stimulation of nasal mucosa in non-allergic rhinitis: comparison of patient self-administration and caregiver administration regarding pain and treatment effect. A randomized clinical trial

Abstract

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.

Chinese abstract

结论 患者自我掌控动力振荡刺激（KOS）导管是一个完全可接受的方法, 来替代 由医生用头盔固定对非过敏性鼻炎（NAR）患者施行导管插入的做法。这两种方法在疼痛方面是等效的。患者自身给药组的治疗效果并不差。

目的 评价KOS导管自我给药与由医师插入是否不同, 根据视觉模拟量表（ＶＡＳ）上患者报告的疼痛度来评估。此外, 用鼻腔结果测试（SNOT-22）和高峰鼻吸气流量（PNIF）评估鼻塞的差异。

方法 将NAR患者随机分为1组：患者导管插入和手工固定；2组：通过医生插入导管, 并用盔固定。患者每个鼻腔中接受10分钟治疗一次, 并在14天后再接受一次治疗。

结果 共包括29名患者（1组, n = 14;2组, n = 15）。患者报告的疼痛在两组之间没有统计学显着差异。在整体研究人群中显示, 治疗后鼻塞度降低（n = 26, p = 0.001）。在1组中, 鼻塞度降低, 2组中没有变化（1组, p = 0.004;2组, p = 0.071）。没有观察到PNIF的统计学显著变化。

Keywords:

• KOS
• idiopathic rhinitis
• vasomotor rhinitis
• nasal stuffiness
• minimally invasive
• low frequency nerve stimulation
• neuromodulation
• autonomic nervous system
• medical device

Acknowledgements

The authors thank: Ingrid Zandén and Ingrid Ölund, Resident physicians at ENT-Clinic, Halmstad County Hospital, for assistance in recruiting patients and preparation of the closed envelope system used for randomization; Amir Baigi (MSc in statistics and associate professor in epidemiology), Anders Holmén, both affiliated to FoUU and Ulf Strömberg (Professor, Department of Community Medicine and Public Health, University of Gothenburg) for assistance regarding study design and statistical analysis; Mats Holmström, Professor MD, Department of Otorhinolaryngology, Karolinska University Hospital for valuable advice; and Pernilla Sahlstrand Johnson, MD, PhD, for the permission to use SNOT-22 in the study.

Disclosure statement

The main authors are related to shareholders in Chordate Medical AB. Finn Jörgensen and Per von Hofsten report no conflicts of interest.