The Effect of Osteopathic Manipulative Techniques on Human Tear Composition

August 22, 2026 updated by: David Duriancik, Lake Erie College of Osteopathic Medicine
This is a pilot study to determine if osteopathic manipulation can alter the concentration of proteins and lipids in human tears.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16506
        • Plaza 38 Medical Offices

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Individuals older than 18 years of age at the time of enrollment
  • Individuals that understand the study procedures and provide voluntary, informed consent
  • Individuals willing and able to receive Osteopathic Manipulative Treatment

Exclusion Criteria:

  • Individuals younger than 18 years of age
  • Individuals who are pregnant or lactating
  • Individuals with infection or inflammatory conditions
  • Individuals physically unable to receive Osteopathic Manipulative Treatment
  • Individuals with dental or oral infection or surgery within the preceding 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham
Other: Sham
Sham protocol including holding of the occiput and thoracic area and cranial vault hold without interaction with the motion.
Experimental: Osteopathic Manipulative Treatment
Sequential Osteopathic Manipulative Treatment of suboccipital 4-step release, occipital mastoid suture release, and sphenopalatine ganglion release.
Other: Osteopathic Manipulative Treatment
Sequential Osteopathic Manipulative Treatment of suboccipital 4-step release, occipital mastoid suture release, and sphenopalatine ganglion release.
Other Names:
  • OMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total tear protein concentration
Time Frame: Baseline, 1 hour, and 1 week
Total protein concentration assessed using the bicinchoninic acid assay
Baseline, 1 hour, and 1 week
Secretory Immunoglobulin A Concentration
Time Frame: Baseline, 1 hour, and 1 week
Human IgA, also known as human immunoglobulin A, is an antibody that is produced by the immune system in response to antigens. It is the most abundant immunoglobulin in mucosal secretions, such as saliva, tears, and breast milk, and plays a key role in defense against pathogens at mucosal surfaces. IgA works by binding to specific antigens and preventing them from entering the body's tissues. It can also activate complement and promote phagocytosis by immune cells. This protein typically represents 5-15% of total protein in tears.
Baseline, 1 hour, and 1 week
Tumor necrosis factor - alpha (TNFa) concentration
Time Frame: Baseline, 1 hour, and 1 week
TNF alpha is a multifunctional proinflammatory cytokine that belongs to the tumor necrosis factor (TNF) superfamily. This cytokine is mainly secreted by macrophage and bind to its receptors, TNFRSF1A/TNFR1 and TNFRSF1B/TNFBR. TNF alpha is involved in the regulation of immune cells, cell proliferation, differentiation, apoptosis, lipid metabolism, and coagulation.
Baseline, 1 hour, and 1 week
Lipocalin-1 concentration
Time Frame: Baseline, 1 hour, and 1 week
The protein encoded by this gene belongs to the lipocalin family. Lipocalins are a group of extracellular proteins that are able to bind lipophiles by enclosure within their structures to minimize solvent contact. This protein may bind hydrophobic ligands and inhibit cysteine proteinases. This protein is also known as Tear Prealbumin and typically represents 15-25% of total protein in tears.
Baseline, 1 hour, and 1 week
secreted Phospholipase A2 (type IIA) concentration
Time Frame: Baseline, 1 hour, and 1 week
Phospholipases A2 (PLA2s) make up a superfamily of enzymes that hydrolyze the ester bond of phosphoglycerides at the sn-2 position to release free fatty acid and lysophospholipids. The sPLA2 responsible for the release of arachidonic acid in inflammation was believed to be Type IIA. Although recently discovered isoforms of PLA2 clearly contribute to the release of arachidonic acid, sPLA2 (Type IIA) continues to be a protein of interest in the field of inflammation.
Baseline, 1 hour, and 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lake Erie College of Osteopathic Medicine

Investigators

  • Principal Investigator: David Duriancik, Ph.D., Lake Erie College of Osteopathic Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

October 2, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 8, 2026

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 22, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33-165

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Subscribe