COVID-19NCT05069636
Lymphatic Osteopathic Manipulative Medicine to Enhance Coronavirus (COVID-19) Vaccination Efficacy
A study testing Lymphatic OMM and Light Touch in people with COVID-19, run by Rowan University at 1 site in United States.
Trial summary
The purpose of this project is to study the impact of Osteopathic Manipulative Medicine (OMM) treatments, such as lymphatic myofascial release and thoracic pump techniques severe acute respiratory syndrome-associated coronavirus 2 (SARS-Cov-2) antibody levels in patients who receive the mRNA-1273 (Moderna) COVID-19… 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
- What is being tested?
- Lymphatic OMM and Light Touch
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2021to 28 Feb 2023
- 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
- Inclusion criteria will include age greater than 18 years old and having safely received the COVID-19 vaccine.
Who cannot join
- Exclusion criteria will include age under 18 years old, malignancy/cancer, ongoing infection, coagulopathy history, use of anticoagulant medications, and fracture or acute injury of the torso neck or upper extremities. Lymphatic OMM is safe during pregnancy and this does not need to be an exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rowan University School of Osteopathic Medicine
Stratford, New Jersey, 08084
About this study
Official title: Lymphatic Osteopathic Manipulative Medicine to Enhance COVID-19 Vaccination Efficacy
The purpose of this project is to study the impact of Osteopathic Manipulative Medicine (OMM) treatments, such as lymphatic myofascial release and thoracic pump techniques severe acute respiratory syndrome-associated coronavirus 2 (SARS-Cov-2) antibody levels in patients who receive the mRNA-1273 (Moderna) COVID-19 vaccine and to consider if these OMM strategies allow a stronger more robust immune response.
- Conditions
- COVID-19
- Being tested
- Lymphatic OMM, Light Touch
- Keywords
- COVID-19, Osteopathic Manipulative Medicine, Antibody
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphatic OMMOther
Patients receive lymphatic myofascial release and thoracic pump techniques.
Light TouchOther
Patients receive a series of light touch techniques.
| Study group | Role | What they receive |
|---|---|---|
| Lymphatic OMM plus Moderna COVID-19 Vaccine regimen | Experimental | Patients receive OMM treatments that will include thoracic inlet and outlet myofascial release, pectoral traction myofascial release, and Miller Thoracic Lymphatic Pump technique plus the Moderna COVID-19 Vaccine regimen. Receives: Other: Lymphatic OMM |
| Light Touch plus Moderna COVID-19 Vaccine regimen | Sham comparator | Patients receive a series of light touch techniques plus the Moderna COVID-19 Vaccine regimen. Receives: Other: Light Touch |
What is being measured
The primary outcome is the main question the study is designed to answer.
severe acute respiratory syndrome-associated coronavirus 2 (SARS-Cov-2) antibody levels
Antibody levels collected via blood draw
Measured: The day of first vaccine dose (baseline), the day of second vaccine dose (at about 4-weeks post first vaccine dose), and 2-weeks post second vaccine dose (at about 6-weeks post first vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start14 Feb 2021
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Why it stopped: The Principal Investigator left Rowan University School of Osteopathic Medicine.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rowan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069636
- Sponsor's protocol ID
- PRO-2021-519
- Status last verified
- Sep 2022
- First submitted
- 29 Sep 2021
- Last updated
- 3 Oct 2022
- 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 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphatic Osteopathic Manipulative Medicine to Enhance COVID-19 Vaccination Efficacy
- ClinicalTrials.gov ID
- NCT05069636
- Acronym / sponsor ID
- PRO-2021-519
- Conditions
- COVID-19
- Keywords
- COVID-19, Osteopathic Manipulative Medicine, Antibody
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Principal Investigator left Rowan University School of Osteopathic Medicine.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rowan UniversityUniversity, hospital or other
- Study start
- 14 Feb 2021 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 6 Oct 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 purpose of this project is to study the impact of Osteopathic Manipulative Medicine (OMM) treatments, such as lymphatic myofascial release and thoracic pump techniques severe acute respiratory syndrome-associated coronavirus 2 (SARS-Cov-2) antibody levels in patients who receive the mRNA-1273 (Moderna) COVID-19 vaccine and to consider if these OMM strategies allow a stronger more robust immune response.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lymphatic OMM plus Moderna COVID-19 Vaccine regimen | Experimental | Other: Lymphatic OMMPatients receive OMM treatments that will include thoracic inlet and outlet myofascial release, pectoral traction myofascial release, and Miller Thoracic Lymphatic Pump technique plus the Moderna COVID-19 Vaccine regimen. |
| Light Touch plus Moderna COVID-19 Vaccine regimen | Sham comparator | Other: Light TouchPatients receive a series of light touch techniques plus the Moderna COVID-19 Vaccine regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria will include age greater than 18 years old and having safely received the COVID-19 vaccine.
Key exclusion criteria (1 listed)
- Exclusion criteria will include age under 18 years old, malignancy/cancer, ongoing infection, coagulopathy history, use of anticoagulant medications, and fracture or acute injury of the torso neck or upper extremities. Lymphatic OMM is safe during pregnancy and this does not need to be an exclusion criteria.
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 |
|---|---|---|
| Lymphatic OMMPatients receive lymphatic myofascial release and thoracic pump techniques. | Other | Lymphatic OMM plus Moderna COVID-19 Vaccine regimen |
| Light TouchPatients receive a series of light touch techniques. | Other | Light Touch plus Moderna COVID-19 Vaccine regimen |
Primary outcome
severe acute respiratory syndrome-associated coronavirus 2 (SARS-Cov-2) antibody levels
Time frame: The day of first vaccine dose (baseline), the day of second vaccine dose (at about 4-weeks post first vaccine dose), and 2-weeks post second vaccine dose (at about 6-weeks post first vaccine dose
Antibody levels collected via blood draw
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphatic OMM and Light Touch in people with COVID-19, run by Rowan 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 1 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: withdrawn, as of the sponsor's last update on 3 Oct 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
severe acute respiratory syndrome-associated coronavirus 2 (SARS-Cov-2) antibody levels (time frame: The day of first vaccine dose (baseline), the day of second vaccine dose (at about 4-weeks post first vaccine dose), and 2-weeks post second vaccine dose (at about 6-weeks post first vaccine dose). 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 3 Oct 2022.