No Disease or Condition is Being Directly Studied, The Focus of the Study in Healthy Volunteers
Conditions
Keywords
Tears, Osteopathic Manipulation
Brief summary
This is a pilot study to determine if osteopathic manipulation can alter the concentration of proteins and lipids in human tears.
Interventions
OTHEROsteopathic Manipulative Treatment
Sequential Osteopathic Manipulative Treatment of suboccipital 4-step release, occipital mastoid suture release, and sphenopalatine ganglion release.
OTHERSham
Sham protocol including holding of the occiput and thoracic area and cranial vault hold without interaction with the motion.
Sponsors
Lake Erie College of Osteopathic Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total tear protein concentration | Baseline, 1 hour, and 1 week | Total protein concentration assessed using the bicinchoninic acid assay |
| Secretory Immunoglobulin A Concentration | 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. |
| Tumor necrosis factor - alpha (TNFa) concentration | 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. |
| Lipocalin-1 concentration | 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. |
| secreted Phospholipase A2 (type IIA) concentration | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Duriancik, Ph.D.
Lake Erie College of Osteopathic Medicine
Outcome results
None listed