An interventional study of Osteopathic Manipulative Treatment and Sham in No Disease or Condition is Being Directly Studied and The Focus of the Study in Healthy Volunteers, sponsored by Lake Erie College of Osteopathic Medicine. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Lake Erie College of Osteopathic Medicine · Not applicable, Interventional, and Basic science
This is a pilot study to determine if osteopathic manipulation can alter the concentration of proteins and lipids in human tears.
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's planned enrollment of 30 is below the median of 65 across 128 interventional studies indexed under Lacerations.
Browse Lacerations studies →Lake Erie College of Osteopathic Medicine is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sequential Osteopathic Manipulative Treatment of suboccipital 4-step release, occipital mastoid suture release, and sphenopalatine ganglion release.
Other: Osteopathic Manipulative Treatment
Other: Sham
Sequential Osteopathic Manipulative Treatment of suboccipital 4-step release, occipital mastoid suture release, and sphenopalatine ganglion release.
Also known as: OMT
Sham protocol including holding of the occiput and thoracic area and cranial vault hold without interaction with the motion.
Total tear protein concentration
Total protein concentration assessed using the bicinchoninic acid assay
Time frame: Baseline, 1 hour, and 1 week
Secretory Immunoglobulin A Concentration
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.
Time frame: Baseline, 1 hour, and 1 week
Tumor necrosis factor - alpha (TNFa) concentration
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.
Time frame: Baseline, 1 hour, and 1 week
Lipocalin-1 concentration
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.
Time frame: Baseline, 1 hour, and 1 week
secreted Phospholipase A2 (type IIA) concentration
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.
Time frame: Baseline, 1 hour, and 1 week
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Oct 2026, 1 month later.
Of 46 non-industry interventional studies with no phase under Lacerations, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 72. This study's planned 1 month is below that.
Counting every sponsor, half of 50 studies reached it within 19 months; a quarter within 12 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Lake Erie College of Osteopathic Medicine