NCT07786467

Brief Summary

The investigators are studying if a specific osteopathic manipulative treatment protocol can improve the immune response (antibody titers) to seasonal influenza vaccination in vulnerable populations, including patients with advanced age and/or adiposity.

Trial Health

63
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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

August 22, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

1.1 years

First QC Date

August 22, 2026

Last Update Submit

August 25, 2026

Conditions

Keywords

Osteopathic ManipulationInfluenza vaccineAgingBody composition

Outcome Measures

Primary Outcomes (1)

  • Hemagglutinin inhibition assay

    Hemagglutinin inhibition assay assess the antibody titers in patient's blood.

    baseline and 4 weeks post vaccination

Study Arms (3)

Thoracic pump only

ACTIVE COMPARATOR

Only thoracic inlet myofascial release

Other: Osteopathic Manipulation

No intervention

SHAM COMPARATOR

No intervention pre- or post-influenza vaccination.

Other: Sham

Complete lymphatic pumping

EXPERIMENTAL

Multiple sites of OMT to occur post-influenza vaccination.

Other: Osteopathic manipulation

Interventions

In this intervention, participants will receive 5 minutes of thoracic inlet myofascial release 2 days prior to influenza vaccination, the day of influenza vaccination and 4 days post-influenza vaccination.

Thoracic pump only
ShamOTHER

In this intervention, participants will receive no osteopathic treatments

No intervention

Eligibility Criteria

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

You may qualify if:

  • Willing to receive OMT
  • Willing to receive influenza vaccine
  • Older than 18 years of age

You may not qualify if:

  • Younger than 18 years of age
  • Pregnancy or lactation
  • Unwilling to receive the influenza vaccine
  • Unwilling to receive OMT
  • Open wounds
  • Bone fractures
  • Moderate to severe osteoporosis
  • Severe COPD
  • Current/active infections
  • Mononucleosis infection within past 6 months
  • Liver cirrhosis
  • Cancer or metastatic disease
  • History of DVT, PE, or blood clotting disorder
  • Individuals taking blood thinning medications, except aspirin
  • Having a pacemaker or other thoracic medical devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Plaza 38 Medical Offices

Erie, Pennsylvania, 16509, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Manipulation, Osteopathicsalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • David Duriancik, Ph.D.

    Lake Erie College of Osteopathic Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Duriancik, Ph.D.

CONTACT

Irv Freeman, J.D., Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 22, 2026

First Posted

August 26, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations