Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT04928456
Brief 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.
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:
NCT04928456
Study Brief:
Protocol Section:
NCT04928456