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Clinical Trials/NCT05112887
NCT05112887CompletedNot Applicable

Osteopathic Manipulative Therapy Effects on Prolonged Post-COVID Olfactory Dysfunction

Ohio University1 site in 1 country20 target enrollmentStarted: March 31, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Smell Intensity

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Individual testing smell function was masked to whether participant was in treatment group or placebo

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

OMT Group

Experimental

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

  2. Engaging the sagittal midline of occiput with pressure until release of the tissue is palpated

  3. Direct pressure along the external region of the transverse sinus until release of the tissue is palpated.

  4. Pressure on sagittal suture with transverse traction until release of the tissue is palpated

  5. Pressure on metopic suture with transverse traction in a pulsatile manner

  6. Vault hold

  7. Appreciate cranial respiratory motion 2. Diagnose cranial strain pattern 3. Place cranial strain pattern into position of ease

Intervention: Osteopathic Manipulative Therapy (Other)

Placebo/Light Touch/Sham Group

Placebo Comparator

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: Osteopathic Manipulative Therapy (Other)

Outcomes

Primary Outcomes

Smell Intensity

Time Frame: 10 minutes will elapse between treatment and post-treatment smell testing.

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

Time Frame: 10 minutes will elapse between treatment and post-treatment smell testing.

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 Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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