Augmentation of Immune Response to COVID-19 mRNA Vaccination Through OMT With Lymphatic Pumps

NCT04928456 | Completed

• 1 other identifier: FB21/IRB026
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

COVID-19; OMT; Vaccination; Osteopathic manipulation

Outcome Measures

Primary Outcomes (3)

• IgM antibody titer levels Percentage Change.

  Percentage change from baseline in IgM assay levels of pre-vaccination titer vs IgM assay levels in subjects receiving control treatment (no OMT) vs subjects receiving intervention treatment (OMT).

  At 1 week, 3 weeks, 4 weeks, 5 weeks, 3 months, 6 months and 1 year post- vaccination.

• IgG antibody titer levels Percentage Change

  Percentage change from baseline in IgG assay levels of pre-vaccination titer vs IgG assay levels in subjects receiving control treatment (no OMT) vs subjects receiving intervention treatment (OMT).

  At 1 week, 3 weeks, 4 weeks, 5 weeks, 3 months, 6 months and 1 year post- vaccination.

• IgM and IgG antibody titer duration

  Time in days in which levels of IgM and IgG assay remain above detectable levels in subjects receiving control treatment (no OMT) vs subjects receiving intervention treatment (OMT) after vaccination.

  At 3 months, 6 months and 1 year post- vaccination.

Secondary Outcomes (2)

• Medication Usage

  Through study completion, an average of 1 year

• Adverse Effects/Side Effects

  Through study completion, an average of 1 year

Study Arms (2)

OMT Intervention Arm

EXPERIMENTAL

OMT will include: 1. Myofascial release of the thoracic inlet: gentle pressure applied to shoulders and neck to move the tissue in different directions with a gentle motion. 2. Pectoral traction: The armpit will be contacted with the finger pads of the doctor and each side will be gently grasped and have a slow pulling force applied towards the shoulders. 3. Diaphragm release with MFR: The doctor will touch below the ribs on each side and will apply gentle pressure and move the tissue from side to side. 4. Splenic pump: below the ribs on the left hand-side, the doctor will apply pressure and release pressure several times to create a vibration over the area just below the ribs. 5. Thoracic pump: The doctor will place their hands over the chest wall on each side and will apply pressure and release pressure several times to generate a pumping action of about 100 times in one minute. Treatment will last 5 minutes with each technique lasting 1 minute.

Other: Osteopathic Manipulative Treatment (OMT)

Control

NO INTERVENTION

Participants in the control group will undergo the same assessments as the OMT intervention arm and will receive their vaccinations, but will not receive any OMT.

Interventions

Osteopathic Manipulative Treatment (OMT) OTHER

Osteopathic Manipulative Treatment (OMT) involves a number of hands-on techniques that are meant to address somatic dysfunction in the body as a part of the osteopathic approach to treating patients. There will be five techniques in total used in the study treatment plan.

OMT Intervention Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are between the ages of 18 and 65 years old
• Will be receiving the mRNA COVID-19 vaccine at Western University of Health Sciences
• Have signed an informed consent form
• Have not previously received a COVID-19 vaccine

You may not qualify if:

• Have contraindications to vaccine and any significant reactions to vaccines
• Have any primary or secondary immune deficiencies or autoimmune disease/immunocompromised
• Have symptoms of COVID-19 at the time of enrollment (eg. Fever, headaches, muscle pain, sore throat, coughing, loss of smell, loss of taste, etc.)
• Have already received a COVID-19 vaccine
• Are using any immune altering medications such as corticosteroids, cyclospoin, tacrolimus, and pimecrolimus
• Are unable to receive OMT with lymphatic techniques due to open wounds, fractures, anuresis, necrotizing faciitis, congestive heart failure, or unstable cardiac conditions
• Are pregnant or breastfeeding
• Are less than 18 years of age or more than 65 years of age
• Were previously treated for COVID-19 with serum transfer or immunological treatments
• Are on anti-coagulation therapy

Sponsors & Collaborators

• Western University of Health Sciences: lead
• American College of Osteopathic Physicians: collaborator
• American Osteopathic Foundation: collaborator
• Osteopathic Physicians and Surgeons of California: collaborator
• Xavier-Nichols Foundation: collaborator

Study Sites (1)

Western University of Health Sciences

Pomona, California, 91766, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Jesus Sanchez, DO

  Professor of Family Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Care providers will not be involved with any of the data acquisition or analysis. Investigators will be blinded to which participants are in each group and will collect data using only subject numbers provided on labels.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Family Medicine

Model Details: The design of this study is a randomized, no-treatment control group, OMT intervention group with a parallel group design.

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 16, 2021
• Study Start: June 11, 2021
• Primary Completion: December 5, 2022
• Study Completion: December 5, 2022
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)