COVID-19 virus

COVID-19 mRNA OMT Randomized Controlled Trial

Closed   ⇒   Not Actively Recruiting

Trial Purpose

The purpose of this study is to determine if Osteopathic Manipulative Treatment (OMT), including lymphatic pumps, when added to COVID-19 mRNA vaccination protocols, will increase antibody production in response to the vaccine. We are also interested in seeing if breakthrough infections will be less severe in those treated with OMT and vaccination versus those with vaccination only. 

 

View full trial information on ClincalTrials.gov

 

National Trial Reference Number

      NCT04928456

 

 

 

Eligibility


 

Gender

Healthy Volunteers

Age Range

All Yes 18+

 

Inclusion Criteria:

  • Individuals must be 18 years or older.
  • Individuals must provide informed consent.
  • Individuals must be healthy with a BMI under 30, with no primary or secondary immune deficiency or autoimmune disease/must not be immunocompromised.
  • Individuals must not be using or recently have used any immune-altering medications such as corticosteroids, cyclosporin, tacrolimus, and pimecrolimus
  • Individuals must not have had lymphatic OMT or other physical manipulation such as acupuncture, physical therapy, chiropractic, or massage therapy in the previous four weeks before study enrollment.
  • Individuals must have the ability to receive OMT with lymphatic techniques.
  • Individuals must be able to tolerate 12 minutes of moderate physical activity.
  • Individuals must not be pregnant or breastfeeding.
  • Individuals must not have had a splenectomy or other spleen or oncologic surgery within the past 6 months.
  • Individuals must be infection-free for the past 6 weeks before starting the study and have not received any immunizations within the past 6 weeks.
  • Individuals must be willing to avoid strenuous activity at least 24 hours before each visit.
  • Individuals must be willing to abstain from moderate to intense activity in the 4 hours between their 2nd blood draw and their final blood draw at each of their three visits.

Exclusion Criteria:

  • Individuals are younger than 18 years of age.
  • Individuals who do not provide informed consent.
  • Individuals with a BMI over 30, or with primary or secondary immune deficiency or autoimmune disease or is immunocompromised.
  • Individuals using or recently have used any immune-altering medications such as corticosteroids, cyclosporin, tacrolimus, and pimecrolimus
  • Individuals who have had lymphatic OMT or other physical manipulation such as acupuncture, physical therapy, chiropractic, or massage therapy in the previous four weeks before study enrollment.
  • Individuals who don't have the ability to receive OMT with lymphatic techniques.
  • Individuals who cannot tolerate 12 minutes of moderate physical activity.
  • Individuals who are pregnant or breastfeeding.
  • Individuals who have had a splenectomy or other spleen or oncologic surgery within the past 6 months.
  • Individuals who have had an infection in the 6 weeks before starting the study and or have received any immunizations within the past 6 weeks.
  • Individuals not willing to avoid strenuous activity at least 24 hours before each visit.
  • Individuals not willing to abstain from moderate to intense activity in the 4 hours between their 2nd blood draw and their final blood draw at each of their three visits.

 

IRB Protocol No
FB21/IRB026
 
 
Category 
Osteopathic Manipulative Medicine (OMM)
Immunology
Vaccinology
 

Principal Investigator

Jesus Sanchez, DO
NMM/OMM and Family Medicine
 
 
Location 
Western University of Health Sciences
Patient Care Center 
 
 
For detailed eligibility,
please visit: ClinicalTrials.gov