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Osteopathic Manipulative Therapy Effects on Prolonged Post-COVID Olfactory Dysfunction

Primary Purpose

COVID-19 Lower Respiratory Infection, SARS-CoV2 Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manipulative Therapy
Sponsored by
Ohio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Lower Respiratory Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ohio University Heritage College of Medicine - Dublin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OMT Group

Placebo/Light Touch/Sham Group

Arm Description

The OMT protocol treatment sequence was performed in the following order: 1. Rib raising from a seated position 2. Suboccipital Release from a supine position 3. Thoracic Inlet Release 4. Miller Lymphatic Pump 5. Pedal Pump 6. Suboccipital Release 7. Cranial Sinus Effleurage Engaging the sagittal midline of occiput with pressure until release of the tissue is palpated Direct pressure along the external region of the transverse sinus until release of the tissue is palpated. Pressure on sagittal suture with transverse traction until release of the tissue is palpated Pressure on metopic suture with transverse traction in a pulsatile manner Vault hold 1. Appreciate cranial respiratory motion 2. Diagnose cranial strain pattern 3. Place cranial strain pattern into position of ease

Participants in the sham/placebo group were lightly touched in equivalent positions to the OMT treatments. First, sham participants were lightly touched on the thoracic cage while seated, followed by light touch of the neck, chest, feet, and cranium while supine. The length of light touch was modeled after the approximate time needed for the OMT matching each treatment region. Each treatment sequence lasted about 20 minutes in total.

Outcomes

Primary Outcome Measures

Smell Intensity
Participants will smell the 4 substances blindfolded and will rank each one from 0-10, 0 being no smell and 10 be pre-COVID smell. Participant will then be treated either with OMT or placebo and then asked to resmell the same 4 smell substances and rank them on the same scale.
Smell Identification
Participants will smell the 4 substances blindfolded and attempt to identify the smells. Participants will then receive treatment either OMT or Placebo and will smell the same 4 substances while attempting to identify them again. Correct answers were given a score of "1" and incorrect answers were given a smell of "0"

Secondary Outcome Measures

Full Information

First Posted
November 5, 2021
Last Updated
November 5, 2021
Sponsor
Ohio University
Collaborators
American Osteopathic Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05112887
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 31, 2021 (Actual)
Primary Completion Date
September 13, 2021 (Actual)
Study Completion Date
September 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio University
Collaborators
American Osteopathic Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 Perfume Red Onion (sliced) Bourbon 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: Perfume Red Onion (sliced) Bourbon 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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Lower Respiratory Infection, SARS-CoV2 Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantOutcomes Assessor
Masking Description
Individual testing smell function was masked to whether participant was in treatment group or placebo
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OMT Group
Arm Type
Experimental
Arm Description
The OMT protocol treatment sequence was performed in the following order: 1. Rib raising from a seated position 2. Suboccipital Release from a supine position 3. Thoracic Inlet Release 4. Miller Lymphatic Pump 5. Pedal Pump 6. Suboccipital Release 7. Cranial Sinus Effleurage Engaging the sagittal midline of occiput with pressure until release of the tissue is palpated Direct pressure along the external region of the transverse sinus until release of the tissue is palpated. Pressure on sagittal suture with transverse traction until release of the tissue is palpated Pressure on metopic suture with transverse traction in a pulsatile manner Vault hold 1. Appreciate cranial respiratory motion 2. Diagnose cranial strain pattern 3. Place cranial strain pattern into position of ease
Arm Title
Placebo/Light Touch/Sham Group
Arm Type
Placebo Comparator
Arm Description
Participants in the sham/placebo group were lightly touched in equivalent positions to the OMT treatments. First, sham participants were lightly touched on the thoracic cage while seated, followed by light touch of the neck, chest, feet, and cranium while supine. The length of light touch was modeled after the approximate time needed for the OMT matching each treatment region. Each treatment sequence lasted about 20 minutes in total.
Intervention Type
Other
Intervention Name(s)
Osteopathic Manipulative Therapy
Other Intervention Name(s)
Osteopathic Manipulative Medicine
Intervention Description
Osteopathic Manipulative Therapy is a type of hands-on manipulative medicine where the physician uses their hands and knowledge of anatomy to encourage the human body to reattain homeostasis.
Primary Outcome Measure Information:
Title
Smell Intensity
Description
Participants will smell the 4 substances blindfolded and will rank each one from 0-10, 0 being no smell and 10 be pre-COVID smell. Participant will then be treated either with OMT or placebo and then asked to resmell the same 4 smell substances and rank them on the same scale.
Time Frame
10 minutes will elapse between treatment and post-treatment smell testing.
Title
Smell Identification
Description
Participants will smell the 4 substances blindfolded and attempt to identify the smells. Participants will then receive treatment either OMT or Placebo and will smell the same 4 substances while attempting to identify them again. Correct answers were given a score of "1" and incorrect answers were given a smell of "0"
Time Frame
10 minutes will elapse between treatment and post-treatment smell testing.
Other Pre-specified Outcome Measures:
Title
Quantitative smell experience
Description
Participants were interviewed prior to pre-treatment smell testing to gain a further understanding of how this ailment affects participants on an individual level.
Time Frame
10 minutes will elapse between treatment and post-treatment smell testing.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Walkowski, DO
Organizational Affiliation
Ohio University
Official's Role
Study Director
Facility Information:
Facility Name
Ohio University Heritage College of Medicine - Dublin
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States

12. IPD Sharing Statement

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Osteopathic Manipulative Therapy Effects on Prolonged Post-COVID Olfactory Dysfunction

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