- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07633496
The Effect of Osteopathic Manipulative Techniques on Human Tear Composition
22. august 2026 opdateret af: David Duriancik, Lake Erie College of Osteopathic Medicine
This is a pilot study to determine if osteopathic manipulation can alter the concentration of proteins and lipids in human tears.
Studieoversigt
Status
Tilmelding efter invitation
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Pennsylvania
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Erie, Pennsylvania, Forenede Stater, 16506
- Plaza 38 Medical Offices
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Sham-komparator: Falsk
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Sham protocol including holding of the occiput and thoracic area and cranial vault hold without interaction with the motion.
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Eksperimentel: Osteopathic Manipulative Treatment
Sequential Osteopathic Manipulative Treatment of suboccipital 4-step release, occipital mastoid suture release, and sphenopalatine ganglion release.
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Sequential Osteopathic Manipulative Treatment of suboccipital 4-step release, occipital mastoid suture release, and sphenopalatine ganglion release.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Total tear protein concentration
Tidsramme: Baseline, 1 hour, and 1 week
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Total protein concentration assessed using the bicinchoninic acid assay
|
Baseline, 1 hour, and 1 week
|
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Secretory Immunoglobulin A Concentration
Tidsramme: 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.
|
Baseline, 1 hour, and 1 week
|
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Tumor necrosis factor - alpha (TNFa) concentration
Tidsramme: 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.
|
Baseline, 1 hour, and 1 week
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Lipocalin-1 concentration
Tidsramme: 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.
|
Baseline, 1 hour, and 1 week
|
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secreted Phospholipase A2 (type IIA) concentration
Tidsramme: 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.
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Baseline, 1 hour, and 1 week
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: David Duriancik, Ph.D., Lake Erie College of Osteopathic Medicine
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
2. oktober 2026
Studieafslutning (Anslået)
31. oktober 2026
Datoer for studieregistrering
Først indsendt
2. juni 2026
Først indsendt, der opfyldte QC-kriterier
2. juni 2026
Først opslået (Faktiske)
8. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 33-165
Plan for individuelle deltagerdata (IPD)
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