Acupuncture Therapy for COVID-Related Olfactory Loss

Not Applicable

Completed

• Conditions: Olfactory Dysfunction; COVID-19
• Interventions: Device: Acupuncture Therapy; Drug: Budesonide; Other: Olfactory Training

• Registration Number: NCT04952389
• Lead Sponsor: Mayo Clinic

Brief Summary

This study is looking at the role of acupuncture as a treatment for olfactory dysfunction in patients who tested positive for COVID-19.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-02
• Study First Posted: 2021-07-07
• Study Start: 2021-12-07
• Primary Completion: 2023-04-21
• Study Completion: 2023-06-09
• Status Verified: 2024-02
• Results First Submitted: 2024-02-15
• Results First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Results First Posted: 2024-03-12
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 18 years or older.
• Patients with post-viral olfactory dysfunction > 4 weeks.
• History of positive COVID-19 PCR.

Read More

Exclusion Criteria

• Less than 18 years of age.
• Active sinus infection.
• New diagnosis of untreated CRS.
• Prior diagnosis of dementia or Parkinson's disease.
• Prior head trauma or neurosurgical procedure resulting in olfactory loss.
• Patients who do not speak or read English.
• Patients unable to understand and sign the study consent.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture Therapy Group	Acupuncture Therapy	Subjects will undergo ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care.
Acupuncture Therapy Group	Budesonide	Subjects will undergo ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care.
Acupuncture Therapy Group	Olfactory Training	Subjects will undergo ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care.
Standard of Care	Budesonide	Subjects will be treated with two times daily budesonide rinses and olfactory (sense of smell) training. This is considered the current standard of care in the treatment of olfactory dysfunction.
Standard of Care	Olfactory Training	Subjects will be treated with two times daily budesonide rinses and olfactory (sense of smell) training. This is considered the current standard of care in the treatment of olfactory dysfunction.

Primary Outcome Measures

Name	Time	Method
Change in University of Pennsylvania Smell Identification Test (UPSIT) Scores	Baseline, post-treatment approximately 12 weeks	The 40-item UPSIT is a measurement of the ability to detect odors where microencapsulated odorants on a strip are released by scratching. Each item is scored from 0 (did not correctly detect the odor) to 1 (correctly detected the odor). Total scores range from 0-40 with higher scores indicating better smell and lower scores indicating worse smell.

Secondary Outcome Measures

Name	Time	Method
Change in Patient-reported Subjective Olfactory Loss	Baseline, post-treatment approximately 12 weeks	Patient-reported subjective olfactory loss measured by a 10-point visual analog scale with 10 representing no sense of smell and 1 representing normal smell.
Change in Sino-Nasal Outcome Test (SNOT-22)	Baseline, post-treatment approximately 12 weeks	Patient-reported subjective olfactory loss measured by SNOT-22 questionnaire, rating symptoms experiences from 0 = no problem, 5 = problem as bad as it can be, with a total score ranging of 0-110, lower scores indicate no problem and higher scores indicate more problem.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States