The Effect of Osteopathic Manipulative Techniques on Human Tear Proteins

NCT07633496 | Not Yet Recruiting

• 1 other identifier: 33-165
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to determine if osteopathic manipulation can alter the concentration of proteins in human tears.

Conditions

The Focus of the Study in Healthy Volunteers; No Disease or Condition is Being Directly Studied

Keywords

Tears; Osteopathic Manipulation

Outcome Measures

Primary Outcomes (5)

• Total tear protein concentration

  Total protein concentration assessed using the BCA assay

  Baseline, 1 hour, and 1 week

• Secretory Immunoglobulin A

  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)

  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

  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)

  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

Study Arms (2)

Osteopathic Manipulative Treatment

EXPERIMENTAL

Sequential OMT of suboccipital 4-step release, occipital mastoid suture release, and sphenopalatine ganglion release.

Other: Osteopathic Manipulative Treatment

Sham

SHAM COMPARATOR

Other: Sham

Interventions

Osteopathic Manipulative Treatment OTHER

Sequential OMT of suboccipital 4-step release, occipital mastoid suture release, and sphenopalatine ganglion release.

Also known as: OMT

Osteopathic Manipulative Treatment

Sham OTHER

Sham protocol including holding of the occiput and thoracic area and cranial vault hold without interaction with the motion.

Sham

Eligibility Criteria

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

You may qualify if:

• 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 OMT

You may not qualify if:

• Individuals younger than 18 years of age
• Individuals who are pregnant or lactating
• Individuals physically unable to receive OMT

Sponsors & Collaborators

• Lake Erie College of Osteopathic Medicine: lead

Study Sites (1)

Plaza 38 Medical Offices

Erie, Pennsylvania, 16506, United States

Location

MeSH Terms

Conditions

Lacerations

Interventions

Manipulation, Osteopathic; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Study Officials

• David Duriancik, Ph.D.

  Lake Erie College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Duriancik, Ph.D.

CONTACT

814-860-5139; dduriancik@lecom.edu

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

CONTACT

724-552-2870; ifreeman1@lecom.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: 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: June 2, 2026
• First Posted: June 8, 2026
• Study Start: July 1, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)