Acupuncture for Olfactory Dysfunction in Infected COVID-19 Patients

Not Applicable

• Conditions: Olfactory Dysfunction; Covid19

• Registration Number: NCT04959747
• Lead Sponsor: Hong Kong Baptist University

Brief Summary

In this a 12-week, single blinded, randomized sham controlled, and cross-over clinical trial. It will be conducted to explore the safety and efficacy of acupuncture for olfactory dysfunction in infected COVID-19 patients in Hong Kong.

Detailed Description

This is a single blinded, randomized sham controlled, and cross-over clinical trial. 40 Post COVID-19 patients presenting to olfactory dysfunction will be recruited. 40 patients will be randomly assigned into 2 groups, the acupuncture group (AC) and the sham acupuncture group (SAC) with 1:1 ratio, for 4-week treatment and 2-week follow-up. After the follow-up, the sham group will be conducted with real acupuncture for another 4 weeks and the real acupuncture group will be conducted with the 4-week sham acupuncture.

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-12
• Study First Posted: 2021-07-13
• Last Update Submitted: 2021-07-17
• Last Update Posted: 2021-07-22
• Study Start: 2021-08-01
• Primary Completion: 2022-07-31
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients who have been previously diagnosed to be infected with COVID-19 and are discharged from local hospitals with all the follows: 1) post COVID-19 olfactory dysfunction with moderate or severe grades (base on UPSIT-TC scores, the cutoff scores are set at 29.5 for male and 30.5 for female); 2) post COVID-19 olfactory dysfunction who did not undergo treatment; 3) no history of trauma, injury or surgery to head or nose or any bleeding from the nose; 4) aged 18 to 80 years who are able to read and write Chinese.

Exclusion Criteria

Patients will be excluded if they have one or more of follows: 1) patients with olfactory or gustatory dysfunctions before the COVID-19 epidemic; 2) patients with history of chronic rhinosinusitis or nasal polyposis; 3) history of nasal surgery (including rhino/septoplasty with or without functional endoscopic sinus surgery; 4) Pregnant or breastfeeding women.; 5) Medical history: cancers, conditions that affect the nervous system, such as Parkinson's disease or Alzheimer's disease, and/or any other serious diseases; 6) Unstable medical conditions; 7) Patients who have received acupuncture treatment within one month, 8) Alcoholism or drug abuse in past 1 year; 9) Have needle phobia; 10) Have known history of developing acupuncture related severe adverse reaction.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
ASOF scores	1, 6, 8, 12, 14 weeks	The Assessment of Self-reported Olfactory Functioning and olfaction related quality of life (ASOF) is a 12-item validated questionnaire, it can be subdivided into three domains: the one-item subjective olfactory capability scale (SOC), the five-item self-reported capability of perceiving specific odors scale (SRP), and the six-item olfactory-related quality of life (ORQ) scale. We proceeded to calculate cutoff scores for the three scales. Patients will be considered to have abnormal olfactory capabilities if the SOC score was equal to or less than 3. Scale from 10 (best possible) to 0 (worst possible-unable to smell). Patients were considered to have problems smelling odors if the SRP score was equal to or less than 2.9 (Scale from 0 to 5) Patients were considered to have smell-related problems in quality of life if the ORQ score was equal to or less than 3.7 (Scale from 0 to 6)
sQOD-NS scores	1, 6, 8, 12, 14 weeks	The Short version of the Questionnaire of Olfactory Disorders-Negative Statements (sQOD-NS) is a 7-item patient-reported outcome questionnaire. Patients rated the item proposition from 0 (agree) to 3 (disagree) with total score ranging from 0 (significant impact of olfactory dysfunction on quality of life) to 21 (no impact on quality of life). The sQOD-NS is composed of seven questions including social, eating, annoyance, and anxiety and assessed using a 4-point Likert scale (0-3). A higher score means better olfactory specific quality of life.

Secondary Outcome Measures

Name	Time	Method
UPSIT-TC	0, 14 weeks	The University of Pennsylvania Smell Identification Test (UPSIT) is widely used internationally and the worldwide standard for olfactory testing. UPSIT is a 40-item "scratch and sniff" multiple choice test to assess how well participants can identify different odors. Patients will be required to identify each of the 40 odors from four alternatives listed for each odor. The number of correct responses provided a test score such that patients could be categorized into one of four categories: mild, moderate, severe, or total loss. The test is scored by the number of odors identified correctly to generate a maximum score of 40.

Trial Locations

Locations (1)

Linda Zhong; 🇭🇰 Kowloon Tong, Kowloon, Hong Kong