An interventional study of Osteopathic Manipulative Treatment (OMT) in Covid19, sponsored by Western University of Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-26.
Sponsored by Western University of Health Sciences · Not applicable, Interventional, and Prevention
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.
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).
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 92 is close to the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Western University of Health Sciences is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Osteopathic Manipulative Treatment (OMT)
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.
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.
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).
Time frame: 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).
Time frame: 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.
Time frame: At 3 months, 6 months and 1 year post- vaccination.
Medication Usage
Assessment of medications that subjects used to negate side effects using a medication log.
Time frame: Through study completion, an average of 1 year
Adverse Effects/Side Effects
Reported side effects from the vaccines or adverse effects experienced from OMT.
Time frame: Through study completion, an average of 1 year
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2021 to primary completion in Dec 2022, 17 months.
Of 1,338 non-industry interventional studies with no phase under COVID-19, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's 17 months is above that.
Counting every sponsor, half of 1,476 studies reached it within 9 months; a quarter within 3 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Western University of Health Sciences