Acupuncture for Olfactory Dysfunction in Infected COVID-19 Patients: Study Protocol for a Single Blind, Randomized, Sham-Controlled Clinical Trial

Abstract Background: Olfactory dysfunction (OD) was recognized as one of common symptom of COVID-19. OD, defined as the reduced or distorted ability to smell during sniffing (orthonasal olfaction) and may represent one of early symptoms in the clinical course of COVID-19 infection. A large online questionnaire-based survey found that some of post COVID-19 patients showed no improvement at one month after they were discharged from hospital. Therefore, this clinical trial is designed to explore the efficacy of acupuncture for OD in infected COVID-19 patients and to determine whether acupuncture could have benefits than sham acupuncture for OD in post- COVID-19 patients.Methods: This is a single blind, randomized controlled, cross over trial. We plan to recruit forty post-COVID-19 patients who are presenting with smell loss or smell distortions more than one month. Qualified patients will be randomly allocated into the intervention group (real acupuncture) or the control group (sham acupuncture) in a 1:1 ratio. Each patient will receive 8 sessions of treatment over 4 week (Cycle 1), and 2-week follow-up. After the follow-up, the control group will be conducted with real acupuncture for another 4 weeks (Cycle 2), and the real acupuncture group will be conducted with the 4-week sham acupuncture. The primary outcomes are the scores change on the questionnaire of olfactory functioning and olfaction related quality of life at weeks 6, 8, 12 and 14 from the baseline. Secondary outcome is the change on the Olfactory Test score at the week 6 and 12 from the baseline measured by using the Traditional Chinese version of the University of Pennsylvania Smell Identification Test (UPSIT-TC).Discussion: The results of this trial will help to determine the effectiveness of acupuncture for OD in post-COVID-19 Patients. This may provide a new treatment option for patients.Trial registration: ClinicalTrials.gov, NCT04959747, Registered on July 13, 2021.