NCT05069636

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

2 years

First QC Date

September 29, 2021

Last Update Submit

September 30, 2022

Conditions

COVID-19

Keywords

COVID-19Osteopathic Manipulative MedicineAntibody

Outcome Measures

Primary Outcomes (1)

  • severe acute respiratory syndrome-associated coronavirus 2 (SARS-Cov-2) antibody levels

    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

Study Arms (2)

Lymphatic OMM plus Moderna COVID-19 Vaccine regimen

EXPERIMENTAL

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

Light Touch plus Moderna COVID-19 Vaccine regimen

SHAM COMPARATOR

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

Other: Light Touch

Interventions

Lymphatic OMMOTHER

Patients receive lymphatic myofascial release and thoracic pump techniques.

Lymphatic OMM plus Moderna COVID-19 Vaccine regimen
Light TouchOTHER

Patients receive a series of light touch techniques.

Light Touch plus Moderna COVID-19 Vaccine regimen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rowan University School of Osteopathic Medicine

Stratford, New Jersey, 08084, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 6, 2021

Study Start

February 14, 2021

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

October 3, 2022

Record last verified: 2022-09

Locations

US(1)