No Disease or Condition is Being Directly StudiedNCT07633496
The Effect of Osteopathic Manipulative Techniques on Human Tear Composition
A study testing Osteopathic Manipulative Treatment in people with No Disease or Condition is Being Directly Studied and The Focus of the Study in Healthy Volunteers, run by Lake Erie College of Osteopathic Medicine at 1 site in United States.
Trial summary
This is a pilot study to determine if osteopathic manipulation can alter the concentration of proteins and lipids in human tears. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- No Disease or Condition is Being Directly Studied, The Focus of the Study in Healthy Volunteers
- What is being tested?
- Osteopathic Manipulative Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This is a pilot study to determine if osteopathic manipulation can alter the concentration of proteins and lipids in human tears.
- Conditions
- No Disease or Condition is Being Directly Studied, The Focus of the Study in Healthy Volunteers
- Being tested
- Osteopathic Manipulative Treatment, Sham
- Keywords
- Tears, Osteopathic Manipulation
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentOther
Also called OMT
Sequential Osteopathic Manipulative Treatment of suboccipital 4-step release, occipital mastoid suture release, and sphenopalatine ganglion release.
ShamOther
Sham protocol including holding of the occiput and thoracic area and cranial vault hold without interaction with the motion.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manipulative Treatment | Experimental | Sequential Osteopathic Manipulative Treatment of suboccipital 4-step release, occipital mastoid suture release, and sphenopalatine ganglion release. Receives: Other: Osteopathic Manipulative Treatment |
| Sham | Sham comparator | Not described Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total tear protein concentration
Total protein concentration assessed using the bicinchoninic acid assay
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 hour, and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion2 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Disease or Condition is Being Directly StudiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lake Erie College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Duriancik, Lake Erie College of Osteopathic Medicine
- Investigators
- David Duriancik, Ph.D., Principal investigator, Lake Erie College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633496
- Sponsor's protocol ID
- 33-165
- Status last verified
- Aug 2026
- First submitted
- 2 Jun 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Osteopathic Manipulative Techniques on Human Tear Composition
- ClinicalTrials.gov ID
- NCT07633496
- Acronym / sponsor ID
- 33-165
- Conditions
- No Disease or Condition is Being Directly Studied, The Focus of the Study in Healthy Volunteers
- Keywords
- Tears, Osteopathic Manipulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lake Erie College of Osteopathic MedicineUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 2 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to determine if osteopathic manipulation can alter the concentration of proteins and lipids in human tears.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manipulative Treatment | Experimental | Other: Osteopathic Manipulative TreatmentSequential Osteopathic Manipulative Treatment of suboccipital 4-step release, occipital mastoid suture release, and sphenopalatine ganglion release. |
| Sham | Sham comparator | Other: Sham |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative TreatmentAlso: OMTSequential Osteopathic Manipulative Treatment of suboccipital 4-step release, occipital mastoid suture release, and sphenopalatine ganglion release. | Other | Osteopathic Manipulative Treatment |
| ShamSham protocol including holding of the occiput and thoracic area and cranial vault hold without interaction with the motion. | Other | Sham |
Primary outcome
Total tear protein concentration
Time frame: Baseline, 1 hour, and 1 week
Total protein concentration assessed using the bicinchoninic acid assay
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Duriancik, Ph.D. principal investigator
Lake Erie College of Osteopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment in people with No Disease or Condition is Being Directly Studied and The Focus of the Study in Healthy Volunteers, run by Lake Erie College of Osteopathic Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total tear protein concentration (time frame: Baseline, 1 hour, and 1 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.