Open AccessEffects and safety of intranasal phototherapy for allergic rhinitis
Author(s) -
JeongIn Kang,
Go-Eun Lee,
Jeonghun Kim,
Youngeun Kim,
Sunju Park,
DongHyo Lee
Publication year - 2020
Publication title -
medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.59
H-Index - 148
eISSN - 1536-5964
pISSN - 0025-7974
DOI - 10.1097/md.0000000000020835
Subject(s) - medicine , nasal administration , randomized controlled trial , placebo , clinical trial , visual analogue scale , adverse effect , quality of life (healthcare) , physical therapy , immunology , alternative medicine , pathology , nursing
Allergic rhinitis (AR) is an immunoglobulin E (Ig E)-mediated inflammatory disease. Intranasal phototherapy is a promising treatment modality because it has a profound immunosuppressive effect, but the available evidence of its use for AR is insufficient. Therefore, rigorously designed randomized controlled trials (RCTs) are needed. Our objective is to describe the protocol for a feasibility trial to assess the effects and safety of intranasal phototherapy for the treatment of AR. Methods and analysis: This is a study protocol for a single-center, randomized, double-blind, parallel, placebo-controlled, investigator-initiated pilot study. A total of 40 patients with AR will be randomly assigned to the medical device or sham device group in a 1:1 ratio. The participants will receive intranasal phototherapy with a medical or sham device for 20 min 5 times a week for 2 weeks. The primary outcome will be the mean change in the Total Nasal Symptom Score (TNSS) from baseline to 2 weeks. The secondary outcomes will include the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, Nasal Endoscopy Index, total serum Ig E level, and eosinophil count. Discussion: The findings of this study will provide the basis for subsequent large-scale definitive RCTs to confirm the effects and safety of intranasal phototherapy for the treatment of nasal symptoms in patients with AR who do not respond well to conventional therapy. This study may assist in the development of noninvasive treatment for patients with AR. Trial registration: This study was registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0003253).