Covid19NCT04928456
Augmentation of Immune Response to COVID-19 mRNA Vaccination Through OMT With Lymphatic Pumps
A study testing Osteopathic Manipulative Treatment (OMT) in people with Covid19, run by Western University of Health Sciences at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of utilizing Osteopathic Manipulative Treatment (OMT) procedures as an addition to current mRNA COVID-19 vaccines in terms of enhancing the immune response of participants as assessed by looking for increased levels and duration of antibody titers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Osteopathic Manipulative Treatment (OMT)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2021to 5 Dec 2022
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are between the ages of 18 and 65 years old
- Will be receiving the mRNA COVID-19 vaccine at Western University of Health Sciences
- Have signed an informed consent form
- Have not previously received a COVID-19 vaccine
Who cannot join
- Have contraindications to vaccine and any significant reactions to vaccines
- Have any primary or secondary immune deficiencies or autoimmune disease/immunocompromised
- Have symptoms of COVID-19 at the time of enrollment (eg. Fever, headaches, muscle pain, sore throat, coughing, loss of smell, loss of taste, etc.)
- Have already received a COVID-19 vaccine
- Are using any immune altering medications such as corticosteroids, cyclospoin, tacrolimus, and pimecrolimus
- Are unable to receive OMT with lymphatic techniques due to open wounds, fractures, anuresis, necrotizing faciitis, congestive heart failure, or unstable cardiac conditions
Show all 10Show fewer
- Are pregnant or breastfeeding
- Are less than 18 years of age or more than 65 years of age
- Were previously treated for COVID-19 with serum transfer or immunological treatments
- Are on anti-coagulation therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Western University of Health Sciences
Pomona, California, 91766
About this study
Official title: Augmentation of Immune Response to COVID-19 mRNA Vaccination Through Osteopathic Manipulative Treatment Including Lymphatic Pumps
This study will evaluate the effectiveness of utilizing Osteopathic Manipulative Treatment (OMT) procedures as an addition to current mRNA COVID-19 vaccines in terms of enhancing the immune response of participants as assessed by looking for increased levels and duration of antibody titers.
Read the detailed description
The COVID-19 pandemic has taken many lives, caused millions to become ill, many hospitalized, it has wreaked havoc on our economy, our mental states, and many other aspects of our lives. Vaccines have provided the world with much needed relief against the pandemic but concerns of vaccine escape and naturally waning antibody titers remain in place. The emergence of new strains are a cause of concern. Standard vaccine protocol does not currently utilize the osteopathic medical approach. It has yet to be seen if OMT improves the immune system's response to the COVID-19 spike protein provided by vaccines. Prior research using OMT with lymphatic treatments has shown improved outcomes for hospitalized patients, patients with various diseases, and improved vaccine delivery for Hepatitis B vaccines. This randomized clinical trial will assess the effectiveness of the addition of OMT to COVID-19 vaccination procedures. Individuals will be recruited from those who present at the WesternU vaccine clinic for their first COVID-19 vaccination and from the incoming classes, current classes, faculty, and staff of the 9 colleges at the university. Volunteers will be consented to the study if they qualify and will be randomly assigned to either the control group who will only receive their vaccinations or into the OMT intervention group who will receive OMT provided by an osteopathic physician or an osteopathic OMM Teaching Fellow the day of each of their two vaccinations and the day following the two vaccinations.
Baseline blood samples will be taken for all subjects enrolled in the study. These baseline blood samples will be analyzed for IgG against nucleocapsid as a control to see if there was any previous infection since this would not be present in vaccinated individuals who had never been exposed and contracted COVID-19 and IgG against the spike protein which would help to track the immunity built up in response to the vaccine. Both groups will then receive their first vaccination and only the OMT intervention group will then undergo OMT after receiving their vaccine. The OMT group will return the next day to receive treatments for a second time. Both groups will have blood drawn for IgG vaccine titers against spike protein at 7 days, 21 days, 28 days, 35 days, 3 months, 6 months, and 12 months. Both groups will be asked to report any side effects and any medications used to combat these side effects throughout the entirety of the study. If a subject were to feel symptoms of COVID-19 during the study they would be asked to take a RT-PCR test so that the infection could be verified and tested for the strain type.
OMT modalities that will be used include myofascial release of the thoracic inlet, pectoral traction, diaphragm release with myofascial release, splenic pump, and thoracic pump. All techniques will be performed on the individuals with each technique lasting a total of 1 minute and the entire treatment lasting a total of 5 minutes.
The primary comparison will be the titer of antibodies at each point of each volunteer as expressed as a percentage of the base line pre-vaccination titer between the intervention group (receiving OMT) compared to the control group (not receiving OMT).
- Conditions
- Covid19
- Being tested
- Osteopathic Manipulative Treatment (OMT)
- Keywords
- COVID-19, OMT, Vaccination, Osteopathic manipulation
- 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 Treatment (OMT)Other
Osteopathic Manipulative Treatment (OMT) involves a number of hands-on techniques that are meant to address somatic dysfunction in the body as a part of the osteopathic approach to treating patients. There will be five techniques in total used in the study treatment plan.
| Study group | Role | What they receive |
|---|---|---|
| OMT Intervention Arm | Experimental | OMT will include:
1. Myofascial release of the thoracic inlet: gentle pressure applied to shoulders and neck to move the tissue in different directions with a gentle motion.
2. Pectoral traction: The armpit will be contacted with the finger pads of the doctor and each side will be gently grasped and have a slow pulling force applied towards the shoulders.
3. Diaphragm release with MFR: The doctor will touch below the ribs on each side and will apply gentle pressure and move the tissue from side to side.
4. Splenic pump: below the ribs on the left hand-side, the doctor will apply pressure and release pressure several times to create a vibration over the area just below the ribs.
5. Thoracic pump: The doctor will place their hands over the chest wall on each side and will apply pressure and release pressure several times to generate a pumping action of about 100 times in one minute.
Treatment will last 5 minutes with each technique lasting 1 minute. Receives: Other: Osteopathic Manipulative Treatment (OMT) |
| Control | No intervention | Participants in the control group will undergo the same assessments as the OMT intervention arm and will receive their vaccinations, but will not receive any OMT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgM antibody titer levels Percentage Change.
Percentage change from baseline in IgM assay levels of pre-vaccination titer vs IgM assay levels in subjects receiving control treatment (no OMT) vs subjects receiving intervention treatment (OMT).
Measured: At 1 week, 3 weeks, 4 weeks, 5 weeks, 3 months, 6 months and 1 year post- vaccination.
IgG antibody titer levels Percentage Change
Percentage change from baseline in IgG assay levels of pre-vaccination titer vs IgG assay levels in subjects receiving control treatment (no OMT) vs subjects receiving intervention treatment (OMT).
Measured: At 1 week, 3 weeks, 4 weeks, 5 weeks, 3 months, 6 months and 1 year post- vaccination.
IgM and IgG antibody titer duration
Time in days in which levels of IgM and IgG assay remain above detectable levels in subjects receiving control treatment (no OMT) vs subjects receiving intervention treatment (OMT) after vaccination.
Measured: At 3 months, 6 months and 1 year post- vaccination.
Secondary outcomes (2)
Medication Usage
Assessment of medications that subjects used to negate side effects using a medication log.
Measured: Through study completion, an average of 1 year
Adverse Effects/Side Effects
Reported side effects from the vaccines or adverse effects experienced from OMT.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start11 Jun 2021
- Primary completion5 Dec 2022
- Study completion5 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design of this study is a randomized, no-treatment control group, OMT intervention group with a parallel group design.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Osteopathic Physicians, American Osteopathic Foundation, Osteopathic Physicians and Surgeons of California, Xavier-Nichols Foundation
- Responsible party
- Principal investigator, Jesus Sanchez, Western University of Health Sciences
- Investigators
- Jesus Sanchez, DO, Principal investigator, Professor of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928456
- Sponsor's protocol ID
- FB21/IRB026
- Status last verified
- Apr 2024
- First submitted
- 11 Jun 2021
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation of Immune Response to COVID-19 mRNA Vaccination Through Osteopathic Manipulative Treatment Including Lymphatic Pumps
- ClinicalTrials.gov ID
- NCT04928456
- Acronym / sponsor ID
- FB21/IRB026
- Conditions
- Covid19
- Keywords
- COVID-19, OMT, Vaccination, Osteopathic manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Western University of Health SciencesUniversity, hospital or other
- Collaborators
- American College of Osteopathic Physicians, American Osteopathic Foundation, Osteopathic Physicians and Surgeons of California, Xavier-Nichols Foundation
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 16 Jun 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.
This study will evaluate the effectiveness of utilizing Osteopathic Manipulative Treatment (OMT) procedures as an addition to current mRNA COVID-19 vaccines in terms of enhancing the immune response of participants as assessed by looking for increased levels and duration of antibody titers.
Detailed description
The COVID-19 pandemic has taken many lives, caused millions to become ill, many hospitalized, it has wreaked havoc on our economy, our mental states, and many other aspects of our lives. Vaccines have provided the world with much needed relief against the pandemic but concerns of vaccine escape and naturally waning antibody titers remain in place. The emergence of new strains are a cause of concern. Standard vaccine protocol does not currently utilize the osteopathic medical approach. It has yet to be seen if OMT improves the immune system's response to the COVID-19 spike protein provided by vaccines. Prior research using OMT with lymphatic treatments has shown improved outcomes for hospitalized patients, patients with various diseases, and improved vaccine delivery for Hepatitis B vaccines. This randomized clinical trial will assess the effectiveness of the addition of OMT to COVID-19 vaccination procedures. Individuals will be recruited from those who present at the WesternU vaccine clinic for their first COVID-19 vaccination and from the incoming classes, current classes, faculty, and staff of the 9 colleges at the university. Volunteers will be consented to the study if they qualify and will be randomly assigned to either the control group who will only receive their vaccinations or into the OMT intervention group who will receive OMT provided by an osteopathic physician or an osteopathic OMM Teaching Fellow the day of each of their two vaccinations and the day following the two vaccinations.
Baseline blood samples will be taken for all subjects enrolled in the study. These baseline blood samples will be analyzed for IgG against nucleocapsid as a control to see if there was any previous infection since this would not be present in vaccinated individuals who had never been exposed and contracted COVID-19 and IgG against the spike protein which would help to track the immunity built up in response to the vaccine. Both groups will then receive their first vaccination and only the OMT intervention group will then undergo OMT after receiving their vaccine. The OMT group will return the next day to receive treatments for a second time. Both groups will have blood drawn for IgG vaccine titers against spike protein at 7 days, 21 days, 28 days, 35 days, 3 months, 6 months, and 12 months. Both groups will be asked to report any side effects and any medications used to combat these side effects throughout the entirety of the study. If a subject were to feel symptoms of COVID-19 during the study they would be asked to take a RT-PCR test so that the infection could be verified and tested for the strain type.
OMT modalities that will be used include myofascial release of the thoracic inlet, pectoral traction, diaphragm release with myofascial release, splenic pump, and thoracic pump. All techniques will be performed on the individuals with each technique lasting a total of 1 minute and the entire treatment lasting a total of 5 minutes.
The primary comparison will be the titer of antibodies at each point of each volunteer as expressed as a percentage of the base line pre-vaccination titer between the intervention group (receiving OMT) compared to the control group (not receiving OMT).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- The design of this study is a randomized, no-treatment control group, OMT intervention group with a parallel group design.
| Arm | Type | Receives |
|---|---|---|
| OMT Intervention Arm | Experimental | Other: Osteopathic Manipulative Treatment (OMT)OMT will include: 1. Myofascial release of the thoracic inlet: gentle pressure applied to shoulders and neck to move the tissue in different directions with a gentle motion. 2. Pectoral traction: The armpit will be contacted with the finger pads of the doctor and each side will be gently grasped and have a slow pulling force applied towards the shoulders. 3. Diaphragm release with MFR: The doctor will touch below the ribs on each side and will apply gentle pressure and move the tissue from side to side. 4. Splenic pump: below the ribs on the left hand-side, the doctor will apply pressure and release pressure several times to create a vibration over the area just below the ribs. 5. Thoracic pump: The doctor will place their hands over the chest wall on each side and will apply pressure and release pressure several times to generate a pumping action of about 100 times in one minute. Treatment will last 5 minutes with each technique lasting 1 minute. |
| Control | No intervention | –Participants in the control group will undergo the same assessments as the OMT intervention arm and will receive their vaccinations, but will not receive any OMT. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are between the ages of 18 and 65 years old
- Will be receiving the mRNA COVID-19 vaccine at Western University of Health Sciences
- Have signed an informed consent form
- Have not previously received a COVID-19 vaccine
Key exclusion criteria (10 listed)
- Have contraindications to vaccine and any significant reactions to vaccines
- Have any primary or secondary immune deficiencies or autoimmune disease/immunocompromised
- Have symptoms of COVID-19 at the time of enrollment (eg. Fever, headaches, muscle pain, sore throat, coughing, loss of smell, loss of taste, etc.)
- Have already received a COVID-19 vaccine
- Are using any immune altering medications such as corticosteroids, cyclospoin, tacrolimus, and pimecrolimus
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 Treatment (OMT)Osteopathic Manipulative Treatment (OMT) involves a number of hands-on techniques that are meant to address somatic dysfunction in the body as a part of the osteopathic approach to treating patients. There will be five techniques in total used in the study treatment plan. | Other | OMT Intervention Arm |
Primary outcome
IgM antibody titer levels Percentage Change.
Time frame: At 1 week, 3 weeks, 4 weeks, 5 weeks, 3 months, 6 months and 1 year post- vaccination.
Percentage change from baseline in IgM assay levels of pre-vaccination titer vs IgM assay levels in subjects receiving control treatment (no OMT) vs subjects receiving intervention treatment (OMT).
IgG antibody titer levels Percentage Change
Time frame: At 1 week, 3 weeks, 4 weeks, 5 weeks, 3 months, 6 months and 1 year post- vaccination.
Percentage change from baseline in IgG assay levels of pre-vaccination titer vs IgG assay levels in subjects receiving control treatment (no OMT) vs subjects receiving intervention treatment (OMT).
IgM and IgG antibody titer duration
Time frame: At 3 months, 6 months and 1 year post- vaccination.
Time in days in which levels of IgM and IgG assay remain above detectable levels in subjects receiving control treatment (no OMT) vs subjects receiving intervention treatment (OMT) after vaccination.
2 secondary outcomes
Medication Usage
Time frame: Through study completion, an average of 1 year
Adverse Effects/Side Effects
Time frame: Through study completion, an average of 1 year
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 26 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Jesus Sanchez, DO principal investigator
Professor of Family Medicine
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 Treatment (OMT) in people with Covid19, run by Western University of Health Sciences 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 4 inclusion and 10 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 26 Apr 2024. 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. 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?
IgM antibody titer levels Percentage Change. (time frame: At 1 week, 3 weeks, 4 weeks, 5 weeks, 3 months, 6 months and 1 year post- vaccination.). The study lists 3 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 26 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.