COVID-19 Lower Respiratory InfectionNCT05112887
Osteopathic Manipulative Therapy Effects on Prolonged Post-COVID Olfactory Dysfunction
A study testing Osteopathic Manipulative Therapy in people with COVID-19 Lower Respiratory Infection and SARS-CoV2 Infection, run by Ohio University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Lower Respiratory Infection, SARS-CoV2 Infection
- What is being tested?
- Osteopathic Manipulative Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2021to 13 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Positive COVID test greater than 14 days prior
- Self-identify a decrease in smell after the resolution of their infection
Who cannot join
- Complete smell recovery after resolution of infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio University Heritage College of Medicine - Dublin
Dublin, Ohio, 43016
About this study
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
Read the 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..
- Being tested
- Osteopathic Manipulative Therapy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TherapyOther
Also called Osteopathic Manipulative Medicine
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.
| Study group | Role | What they receive |
|---|---|---|
| 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
1. Engaging the sagittal midline of occiput with pressure until release of the tissue is palpated
2. Direct pressure along the external region of the transverse sinus until release of the tissue is palpated.
3. Pressure on sagittal suture with transverse traction until release of the tissue is palpated
4. Pressure on metopic suture with transverse traction in a pulsatile manner
5. Vault hold
1. Appreciate cranial respiratory motion 2. Diagnose cranial strain pattern 3. Place cranial strain pattern into position of ease Receives: Other: Osteopathic Manipulative Therapy |
| 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. Receives: Other: Osteopathic Manipulative Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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"
Measured: 10 minutes will elapse between treatment and post-treatment smell testing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start31 Mar 2021
- Primary completion13 Sep 2021
- Study completion13 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Lower Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- American Osteopathic Foundation
- Responsible party
- Sponsor
- Investigators
- Steven Walkowski, DO, Study director, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112887
- Sponsor's protocol ID
- 21-F-13
- Status last verified
- Mar 2021
- First submitted
- 5 Nov 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manipulative Therapy Effects on Prolonged Post-COVID Olfactory Dysfunction
- ClinicalTrials.gov ID
- NCT05112887
- Acronym / sponsor ID
- 21-F-13
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- American Osteopathic Foundation
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 13 Sep 2021 (actual)
- Study completion
- 13 Sep 2021 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| OMT Group | Experimental | Other: Osteopathic Manipulative TherapyThe 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 1. Engaging the sagittal midline of occiput with pressure until release of the tissue is palpated 2. Direct pressure along the external region of the transverse sinus until release of the tissue is palpated. 3. Pressure on sagittal suture with transverse traction until release of the tissue is palpated 4. Pressure on metopic suture with transverse traction in a pulsatile manner 5. Vault hold 1. Appreciate cranial respiratory motion 2. Diagnose cranial strain pattern 3. Place cranial strain pattern into position of ease |
| Placebo/Light Touch/Sham Group | Placebo comparator | Other: Osteopathic Manipulative TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Positive COVID test greater than 14 days prior
- Self-identify a decrease in smell after the resolution of their infection
Key exclusion criteria (1 listed)
- Complete smell recovery after resolution of infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative TherapyAlso: Osteopathic Manipulative MedicineOsteopathic 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 | OMT Group, Placebo/Light Touch/Sham Group |
Primary outcome
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"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Walkowski, DO study director
Ohio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Therapy in people with COVID-19 Lower Respiratory Infection and SARS-CoV2 Infection, run by Ohio University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smell Intensity (time frame: 10 minutes will elapse between treatment and post-treatment smell testing.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.