NCT07622966

Brief Summary

The goal of this clinical trial is to learn if osteopathic manipulative treatment (OMT) changes levels of immune markers in healthy volunteers. The main questions it aims to answer are: Does OMT change numbers of white blood cells or antibodies? Does OMT change levels of cytokines? Researchers will compare volunteers treated with OMT to volunteers undergoing sham treatment to see if OMT changes levels of immune markers. Participants will:

  • complete a survey about their medical history to determine if they are healthy enough for OMT
  • have blood drawn
  • undergo either sham treatment or OMT
  • have blood drawn 30 minutes after treatment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 10, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 28, 2026

Last Update Submit

May 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in Circulating Immune Markers

    within 30 minutes of treatment

Study Arms (2)

Osteopathic Manipulative Treatment (OMT)

EXPERIMENTAL
Other: Osteopathic Manipulative Treatment (OMT)

Sham Treatment

SHAM COMPARATOR
Other: Sham Comparator

Interventions

Lymphatic Pump Techniques

Osteopathic Manipulative Treatment (OMT)

Light touch

Sham Treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects are healthy; have independently read, understood, and without coercion signed the consent form; agree to allow for samples to be taken; agree to fill out all the documentation and surveys; and identifies as any race(s), ethnicity(ies), and/or gender(s)

You may not qualify if:

  • subjects present at initial visit with a fever greater than 100.5 °F; have participated in a clinical trial within the last 6 months; work night shifts; who are immunocompromised including: HIV+, have had cancers, or are pregnant or nursing; have current bone fractures of the head and neck; history of osteoporosis, acute hepatitis, deep vein thrombosis, pulmonary embolism, trauma to the liver or spleen, surgery in the past 6 months or necrotizing fasciitis. Other relative contraindications to receiving OMT include doderate to severe cardiac conditions, moderate to severe congestive heart failure, infectious mononucleosis, chronic abscesses or osteomyelitis, coagulopathies or patients on anticoagulants, COPD, and acute indurated lymph node

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edward Via College of Osteopathic Medicine

Monroe, Louisiana, 71203, United States

Location

MeSH Terms

Interventions

Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Discipline Chair for Immunology and Microbiology

Study Record Dates

First Submitted

May 28, 2026

First Posted

June 3, 2026

Study Start

January 10, 2025

Primary Completion

June 17, 2025

Study Completion

June 17, 2025

Last Updated

June 3, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

IPD sharing was not part of patients informed consent

Locations