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

Primary Purpose

COVID-19

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lymphatic OMM
Light Touch
Sponsored by
Rowan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COVID-19 focused on measuring COVID-19, Osteopathic Manipulative Medicine, Antibody

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Rowan University School of Osteopathic Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Lymphatic OMM plus Moderna COVID-19 Vaccine regimen

Light Touch plus Moderna COVID-19 Vaccine regimen

Arm Description

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.

Patients receive a series of light touch techniques plus the Moderna COVID-19 Vaccine regimen.

Outcomes

Primary Outcome Measures

severe acute respiratory syndrome-associated coronavirus 2 (SARS-Cov-2) antibody levels
Antibody levels collected via blood draw

Secondary Outcome Measures

Full Information

First Posted
September 29, 2021
Last Updated
September 30, 2022
Sponsor
Rowan University
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1. Study Identification

Unique Protocol Identification Number
NCT05069636
Brief Title
Lymphatic Osteopathic Manipulative Medicine to Enhance Coronavirus (COVID-19) Vaccination Efficacy
Official Title
Lymphatic Osteopathic Manipulative Medicine to Enhance COVID-19 Vaccination Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The Principal Investigator left Rowan University School of Osteopathic Medicine.
Study Start Date
February 14, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rowan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Osteopathic Manipulative Medicine, Antibody

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lymphatic OMM plus Moderna COVID-19 Vaccine regimen
Arm Type
Experimental
Arm Description
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.
Arm Title
Light Touch plus Moderna COVID-19 Vaccine regimen
Arm Type
Sham Comparator
Arm Description
Patients receive a series of light touch techniques plus the Moderna COVID-19 Vaccine regimen.
Intervention Type
Other
Intervention Name(s)
Lymphatic OMM
Intervention Description
Patients receive lymphatic myofascial release and thoracic pump techniques.
Intervention Type
Other
Intervention Name(s)
Light Touch
Intervention Description
Patients receive a series of light touch techniques.
Primary Outcome Measure Information:
Title
severe acute respiratory syndrome-associated coronavirus 2 (SARS-Cov-2) antibody levels
Description
Antibody levels collected via blood draw
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Rowan University School of Osteopathic Medicine
City
Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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