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OpenTrials
Completed

NCT Number: NCT05112887

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio University Heritage College of Medicine - Dublin

Dublin, Ohio, 43016, United States

About this study

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 [email protected]. 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..

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteopathic Manipulative Therapy

Other

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

Primary outcomes

  1. 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.

  2. 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"

Other outcomes

  1. Quantitative smell experience

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

    Participants were interviewed prior to pre-treatment smell testing to gain a further understanding of how this ailment affects participants on an individual level.

Sponsors and collaborators

Lead sponsor

Ohio University

Other

Collaborators

  • American Osteopathic Foundation

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 9, 2021
Registry last updated
Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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