- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07622966
Effect of Osteopathic Manipulation on Circulating Immune Markers
A Molecular Approach to Examining the Immune Stimulatory Impact of Lymphatic Pump Technique in Healthy Patients; A Pilot Study
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Louisiana
-
Monroe, Louisiana, United States, 71203
- Edward Via College of Osteopathic Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Sham Treatment
|
Light touch
|
|
Experimental: Osteopathic Manipulative Treatment (OMT)
|
Lymphatic Pump Techniques
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in Circulating Immune Markers
Time Frame: within 30 minutes of treatment
|
within 30 minutes of treatment
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2153344-1
- 24081882 (Other Grant/Funding Number: American Osteopathic Association)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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