No Disease or Condition is Being Directly StudiedNCT07786467
Optimizing Lymphatic Pumping for Influenza Vaccine Responses in Vulnerable Populations
A study testing Osteopathic Manipulation 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
The investigators are studying if a specific osteopathic manipulative treatment protocol can improve the immune response (antibody titers) to seasonal influenza vaccination in vulnerable populations, including patients with advanced age and/or adiposity. 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 Manipulation
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Oct 2027
- 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
- Willing to receive OMT
- Willing to receive influenza vaccine
- Older than 18 years of age
Who cannot join
- Younger than 18 years of age
- Pregnancy or lactation
- Unwilling to receive the influenza vaccine
- Unwilling to receive OMT
- Open wounds
- Bone fractures
Show all 15Show fewer
- Moderate to severe osteoporosis
- Severe COPD
- Current/active infections
- Mononucleosis infection within past 6 months
- Liver cirrhosis
- Cancer or metastatic disease
- History of DVT, PE, or blood clotting disorder
- Individuals taking blood thinning medications, except aspirin
- Having a pacemaker or other thoracic medical devices
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Plaza 38 Medical Offices
Erie, Pennsylvania, 16509
Jacob Cukierski, DO, 814-860-8414, jcukierski@lecom.edu
Stephany Esper, DO, 814-860-8463, sesper@lecom.edu
About this study
The investigators are studying if a specific osteopathic manipulative treatment protocol can improve the immune response (antibody titers) to seasonal influenza vaccination in vulnerable populations, including patients with advanced age and/or adiposity.
- Conditions
- No Disease or Condition is Being Directly Studied, The Focus of the Study in Healthy Volunteers
- Being tested
- Osteopathic Manipulation, Sham
- Keywords
- Osteopathic Manipulation, Influenza vaccine, Aging, Body composition
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic ManipulationOther
In this intervention, participants will receive 5 minutes of thoracic inlet myofascial release 2 days prior to influenza vaccination, the day of influenza vaccination and 4 days post-influenza vaccination.
Osteopathic manipulationOther
In this intervention, participants will receive osteopathic manipulation 2 days prior to influenza vaccination, the day of influenza vaccination, and 4 days post-influenza vaccination. The OMT will include thoracic inlet myofascial release, pectoral traction, rib raising, doming of the diaphragm, pelvic diaphragm release, popliteal fossa release, plantar myofascial release, passive Miller thoracic pump, liver pump, and spleen pump.
ShamOther
In this intervention, participants will receive no osteopathic treatments
| Study group | Role | What they receive |
|---|---|---|
| Thoracic pump only | Active comparator | Only thoracic inlet myofascial release Receives: Other: Osteopathic Manipulation |
| No intervention | Sham comparator | No intervention pre- or post-influenza vaccination. Receives: Other: Sham |
| Complete lymphatic pumping | Experimental | Multiple sites of OMT to occur post-influenza vaccination. Receives: Other: Osteopathic manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemagglutinin inhibition assay
Hemagglutinin inhibition assay assess the antibody titers in patient's blood.
Measured: baseline and 4 weeks post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT07786467
- Sponsor's protocol ID
- 33-007
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2026
- Last updated
- 23 Sep 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Lymphatic Pumping for Influenza Vaccine Responses in Vulnerable Populations
- ClinicalTrials.gov ID
- NCT07786467
- Acronym / sponsor ID
- 33-007
- Conditions
- No Disease or Condition is Being Directly Studied, The Focus of the Study in Healthy Volunteers
- Keywords
- Osteopathic Manipulation, Influenza vaccine, Aging, Body composition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Lake Erie College of Osteopathic MedicineUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 26 Aug 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.
The investigators are studying if a specific osteopathic manipulative treatment protocol can improve the immune response (antibody titers) to seasonal influenza vaccination in vulnerable populations, including patients with advanced age and/or adiposity.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thoracic pump only | Active comparator | Other: Osteopathic ManipulationOnly thoracic inlet myofascial release |
| No intervention | Sham comparator | Other: ShamNo intervention pre- or post-influenza vaccination. |
| Complete lymphatic pumping | Experimental | Other: Osteopathic manipulationMultiple sites of OMT to occur post-influenza vaccination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to receive OMT
- Willing to receive influenza vaccine
- Older than 18 years of age
Key exclusion criteria (15 listed)
- Younger than 18 years of age
- Pregnancy or lactation
- Unwilling to receive the influenza vaccine
- Unwilling to receive OMT
- Open wounds
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 ManipulationIn this intervention, participants will receive 5 minutes of thoracic inlet myofascial release 2 days prior to influenza vaccination, the day of influenza vaccination and 4 days post-influenza vaccination. | Other | Thoracic pump only |
| Osteopathic manipulationIn this intervention, participants will receive osteopathic manipulation 2 days prior to influenza vaccination, the day of influenza vaccination, and 4 days post-influenza vaccination. The OMT will include thoracic inlet myofascial release, pectoral traction, rib raising, doming of the diaphragm, pelvic diaphragm release, popliteal fossa release, plantar myofascial release, passive Miller thoracic pump, liver pump, and spleen pump. | Other | Complete lymphatic pumping |
| ShamIn this intervention, participants will receive no osteopathic treatments | Other | No intervention |
Primary outcome
Hemagglutinin inhibition assay
Time frame: baseline and 4 weeks post vaccination
Hemagglutinin inhibition assay assess the antibody titers in patient's blood.
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 23 Sep 2026.
- Individual participant dataSharing planned: No
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No Disease or Condition is Being Directly Studied, The Focus of the Study in Healthy Volunteers
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 Manipulation 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 15 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: looking for participants now, as of the sponsor's last update on 23 Sep 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?
Contact David Duriancik, Ph.D. (814-860-5139, dduriancik@lecom.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemagglutinin inhibition assay (time frame: baseline and 4 weeks post vaccination). 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 23 Sep 2026.