Lymphatic Osteopathic Manipulative Medicine to Enhance Coronavirus (COVID-19) Vaccination Efficacy

September 30, 2022 updated by: Rowan University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Stratford, New Jersey, United States, 08084
        • Rowan University School of Osteopathic Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion criteria will include age greater than 18 years old and having safely received the COVID-19 vaccine.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lymphatic OMM plus Moderna COVID-19 Vaccine regimen
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.
Other: Lymphatic OMM
Patients receive lymphatic myofascial release and thoracic pump techniques.
Sham Comparator: Light Touch plus Moderna COVID-19 Vaccine regimen
Patients receive a series of light touch techniques plus the Moderna COVID-19 Vaccine regimen.
Other: Light Touch
Patients receive a series of light touch techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rowan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2021

Primary Completion (Anticipated)

February 28, 2023

Study Completion (Anticipated)

February 28, 2023

Study Registration Dates

First Submitted

September 29, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (Actual)

October 6, 2021

Study Record Updates

Last Update Posted (Actual)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 30, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-2021-519

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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