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Enrolling by invitation

NCT Number: NCT07633496

The Effect of Osteopathic Manipulative Techniques on Human Tear Composition

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

Enrolling by invitation

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Key information

Conditions

No Disease or Condition is Being Directly Studied Lacerations The Focus of the Study in Healthy Volunteers Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Plaza 38 Medical Offices

Erie, Pennsylvania, 16506, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Osteopathic manipulative treatment

Other

Sequential Osteopathic Manipulative Treatment of suboccipital 4-step release, occipital mastoid suture release, and sphenopalatine ganglion release.

Other names: OMT

SHAM

Other

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

Primary outcomes

  1. Total tear protein concentration

    Time frame: Baseline, 1 hour, and 1 week

    Total protein concentration assessed using the bicinchoninic acid assay

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Lake Erie College of Osteopathic Medicine

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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