Osteopathic Manipulative Therapy Effects on Prolonged Post-COVID Olfactory Dysfunction

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

Study Overview

• Status: Completed
• Conditions: SARS-CoV2 Infection; COVID-19 Lower Respiratory Infection
• Intervention / Treatment: Other: Osteopathic Manipulative Therapy

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..

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Dublin, Ohio, United States, 43016
      • Ohio University Heritage College of Medicine - Dublin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OMT Group; 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	Other: Osteopathic Manipulative Therapy; 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.; Other Names: Osteopathic Manipulative Medicine
Placebo Comparator: Placebo/Light Touch/Sham Group; 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.	Other: Osteopathic Manipulative Therapy; 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.; Other Names: Osteopathic Manipulative Medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 minutes will elapse between treatment and post-treatment smell testing.
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"	10 minutes will elapse between treatment and post-treatment smell testing.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative smell experience	Participants were interviewed prior to pre-treatment smell testing to gain a further understanding of how this ailment affects participants on an individual level.	10 minutes will elapse between treatment and post-treatment smell testing.

Collaborators and Investigators

• Sponsor: Ohio University
• Collaborators: American Osteopathic Foundation
• Investigators: Study Director: Steven Walkowski, DO, Ohio University

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Actual): September 13, 2021
• Study Completion (Actual): September 13, 2021

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 21-F-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No