Clinical trial NCT05112887: Osteopathic Manipulative Therapy Effects on Prolonged Post-COVID Olfactory Dysfunction
Official title: Osteopathic Manipulative Therapy Effects on Prolonged Post-COVID Olfactory Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Lower Respiratory Infection
SARS-CoV2 Infection
Lead sponsor: Ohio University
Sponsor class: OTHER
Collaborators: name: American Osteopathic Foundation
First posted: 2021-11-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will have to email a positive COVID-19 test result \>14 days prior to MS861918@ohio.edu. There will be a correspondence with the participant to ask them if they feel their sense is still decreased or absent and then candidacy for study will be determined. 20 participants will be divided randomly into sham OMT treatment groups and real OMT treatments. 10 in each group. Participants will rate on a scale of 0-10 (0 being no smell, and 10 being pre-COVID19 exposure smell) the ability to smell 4 items blindfolded pre-treatment as well as attempt to identify the substance
Primary purpose: TREATMENT

Brief summary: The goal of this project is to determine the efficacy of a treatment method that increase a participants sense of smell after suffering from COVID-19 related decline in smell. Participants have to be greater than 14 days from positive COVID-19 test and still have a decreased sense of smell. https://jaoa.org/article.aspx?articleid=2765119 this article is a review of literature regarding why OMT can have a positive effect on individuals suffering from COVID-19

Anosmia: Complete loss of smell Hyposmia: Decrease in smell

Detailed description: The goal of this project will be to determine if OMT can return the sense of smell to participants who previously contracted COVID-19.

Participants will have to email a positive COVID-19 test result \>14 days prior to MS861918@ohio.edu. There will be a correspondence with the participant to ask them if they feel their sense is still decreased or absent and then candidacy for study will be determined.

20 participants will be divided randomly into sham OMT treatment groups and real OMT treatments. 10 in each group

Participants will rate on a scale of 0-10 (0 being no smell, and 10 being pre-COVID19 exposure smell) the ability to smell the following items blindfolded pre-treatment as well as attempt to identify the substance:

These will be performed with

1. Perfume
2. Red Onion (sliced)
3. Bourbon
4. Orange

Participants in the sham treatment group will receive a non-osteopathic approach to treatment, which will consist of general palpation of head/neck/shoulder region. Participants in the Osteopathic Manipulation Therapy (OMT) group will receive:

* Rib raising
* Suboccipital Release
* Thoracic Inlet Release
* Miller Thoracic Pump
* Pedal Pump
* Cranial OMT, Performed Indirect Vault hold at conclusion

Stevan Walkowski, D.O. will be providing treatment to both the OMT and Sham group.

Participants will rate on a scale of 0-10 (0 being no smell, and 10 being pre-COVID19 exposure smell) to smell the following items blindfolded pre-treatment as well as attempt to identify the substance 10 min post-treatment:

1. Perfume
2. Red Onion (sliced)
3. Bourbon
4. Orange

Participants will be debriefed following the research procedure. They will be informed of potential side effects that is listed in the risks or discomfort category and will be encouraged to drink water following treatment.

Side effects from sham treatment group: Frustration of not re-acquiring sense of smell

Side effects from OMT treatment group: Headache, dizziness, increase secretion (diarrhea, diuresis) from increase in fluid flow, frustration of not re-acquiring sense of smell

Participants in both groups will be told of the side effects of the OMT treatment group and will be encouraged to drink water following treatment.

Benefits from sham treatment group: none

Benefits from OMT treatment group: May have an increase sense of smell post-treatment

Multiple post-COVID19 individuals who lost sense of smell continue to have a decrease sense of smell after surviving the illness. These people have a decreased ability to smell food, drinks and enjoy shared human experiences which can lead to isolation. Individuals who have a decrease sense of smell are also in increased danger due to not being able to smell hazardous events around them i.e. smoke from a fire, gas filling their house from a leaking gas stove, spoiled food etc..

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Positive COVID test greater than 14 days prior
* Self-identify a decrease in smell after the resolution of their infection

Exclusion Criteria:

* Complete smell recovery after resolution of infection

Primary outcomes:
measure: Smell Intensity
timeFrame: 10 minutes will elapse between treatment and post-treatment smell testing.
measure: Smell Identification
timeFrame: 10 minutes will elapse between treatment and post-treatment smell testing.
Secondary outcomes:
Other outcomes:
measure: Quantitative smell experience
timeFrame: 10 minutes will elapse between treatment and post-treatment smell testing.
Locations:
city: Dublin
country: United States
facility: Ohio University Heritage College of Medicine - Dublin
state: Ohio
Study officials:
affiliation: Ohio University
name: Steven Walkowski, DO
role: STUDY_DIRECTOR
References: