InflammationNCT06820684
Inflammatory Response to OMT
A study testing Osteopathic Manipulative Treatment (OMT) in people with Inflammation and Inflammatory Response, run by Pacific Northwest University of Health Sciences at 1 site in United States.
Trial summary
Investigators will evaluate inflammation before and after an osteopathic manipulative treatment (OMT) in healthy adults, 18-59 years of age. Investigators will look at proteins in the blood called "cytokines". Cytokines can be pro-inflammatory, or anti-inflammatory. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Inflammatory Response
- What is being tested?
- Osteopathic Manipulative Treatment (OMT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least 110 lbs.
- Age within stated required range of 18-59 years of age
- BMI <35
- Non-pregnant
- Generally healthy by self-report
- Free from chronic conditions
Show all 19Show fewer
- Not taking any daily medications
- Willing to abstain from substance use including alcohol and tobacco for 48 hours prior to blood collection
- Willing to fast for 8 hours before blood draw
- Willing to refrain from exercising >48-hr prior to the study visit
- Willing to abstain from abstain from anti-inflammatory medications (e.g., NSAIDs) for at least one week prior to the study visit
- Free of cold and flu symptoms the day of collection
- No infections within two weeks prior to collection
- No symptoms of a heart condition within the six months prior to collection
- No known blood disorder or blood clotting disorder
- No known sickle cell disease
- No known anemia
- Including the study draw, blood donation for clinical or research purposes during the preceding eight weeks will not exceed 550 ml
- No more than one blood draw has occurred during the preceding week
Who cannot join
- Not in the required age range
- Use of daily medications
- Unable or unwilling to meet the inclusion criteria
- Additional diagnostic tests or urgent/emergent procedures needed beyond study exam procedures
- Any history of vertebral artery pathology
- Any history of congestive heart failure
Show all 18Show fewer
- Any history of diagnosed or suspected osteoporosis
- Any recent (90 days) infections, inflammatory condition, fractures, surgery, anesthesia, or traumas
- History of malignancies, autoimmune disease, radiation, or chemotherapy at any time
- Individuals with severe psychiatric illness
- Any on-going or pending medical, health or disability related litigation, or current pursuit of disability
- Dementia or cognitive deficits
- A danger to self or others
- Current smoker or smoking within the past 6 months
- Current substance use disorder, including alcohol
- Inability to abstain from over-the-counter anti-inflammatories for the duration of the study (needed for plasma cytokine assessment)
- Unwilling to consent to multiple blood draws
- Unwilling or unable to adhere to all study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pacific Northwest University of Health Sciences (PNWU)
Yakima, Washington, 98901
About this study
Investigators will evaluate inflammation before and after an osteopathic manipulative treatment (OMT) in healthy adults, 18-59 years of age. Investigators will look at proteins in the blood called "cytokines". Cytokines can be pro-inflammatory, or anti-inflammatory. Investigators think OMT will reduce pro-inflammatory cytokines and increase anti-inflammatory cytokines. Investigators have selected 4 cytokines (out of a potential 30) that investigators believe, based on the literature, are most likely to change over a brief time period. This project will lay essential groundwork at the investigators' institution for future research where they will study the effects of OMT in persons with diabetes (DM) and diabetic peripheral neuropathy (DPN). DPN is a common complication of DM and has few treatment options. OMT has never been specifically studied as a treatment for DPN, and if this pilot study shows significant findings, future work in adults with DPN could be useful.
If investigators detect no changes in cytokines, this pilot work is still important. Investigators need to confirm selected tests are sensitive enough to pick up baseline levels of cytokines in healthy people, where there is expected to be low levels of pro-inflammatory markers (IL-6, TNF-alpha, IL-1b), and higher levels of anti-inflammatory markers (IL-10). Investigators will also use these data as comparison for future work in people with expectedly higher levels of inflammation due to diabetes with complications (e.g., DPN). If markers measured in this pilot study don't show anything, investigators can look at additional cytokines in future analyses. Lastly, it's clear that most people have chronic low-level inflammation without showing or experiencing overt disease; there is a likelihood that investigators will still detect changes, even in a healthy population.
Read the detailed description
Study Hypothesis:
- OMT will reduce acute pro-inflammatory markers.
- OMT will increase acute anti-inflammatory markers.
- Conditions
- Inflammation, Inflammatory Response
- Being tested
- Osteopathic Manipulative Treatment (OMT)
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative Treatment (OMT)Procedure or surgery
The OMT protocol will be delivered as follows:
- Touching and applying gentle pressure to the participant's upper shoulder area (this is called Thoracic inlet direct myofascial release)
- Touching and applying gentle pressure to the participant's midsection and abdomen (this is called Abdominal diaphragm direct myofascial release)
- Touching and applying gentle pressure to the participant's pelvis and sacrum (this is called Muscle Energy or Counterstrain, if indicated).
- Touching and applying gentle pressure to the participant's hips and hamstrings (this is called muscle energy) and will be done in 3 repeated rounds of 5 seconds each.
- Touching and applying gentle pressure to the backs of the participant's knees (this is called open popliteal fossa with direct myofascial release)
- Touching and applying gentle pressure to the participant's feet, moving them back and forth in 10 rhythmic pulses (this is called Pedal Pump)
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manipulative Treatment (OMT) | Experimental | There will be only one arm for this study. All participants will receive the OMT intervention. Receives: Procedure: Osteopathic Manipulative Treatment (OMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-10 Concentration (pg/mL)
Serum IL-10 concentration (pg/mL) will be determined using ELISA assays conducted in triplicate using human ELISA Kits from Millipore Sigma according to manufacturer's directions. Cytokine standards will be used to generate a standard curve, and mean absorbance of experimental samples will be plotted to determine concentration. Data will be synthesized using SoftMax Pro v7.1 and analyzed using Microsoft Excel v2405 and GraphPad v10.2.2.
Measured: Baseline (pre-OMT intervention), and 5-minutes, 30-minutes, and 60-minutes post-OMT
IL-6 Concentration (pg/mL)
Serum IL-6 concentration (pg/mL) will be determined using ELISA assays conducted in triplicate using human ELISA Kits from Millipore Sigma according to manufacturer's directions. Cytokine standards will be used to generate a standard curve, and mean absorbance of experimental samples will be plotted to determine concentration. Data will be synthesized using SoftMax Pro v7.1 and analyzed using Microsoft Excel v2405 and GraphPad v10.2.2.
Measured: Baseline (pre-OMT intervention), and 5-minutes, 30-minutes, and 60-minutes post-OMT
IL-1β Concentration (pg/mL)
Serum IL-1β concentration (pg/mL) will be determined using ELISA assays conducted in triplicate using human ELISA Kits from Millipore Sigma according to manufacturer's directions. Cytokine standards will be used to generate a standard curve, and mean absorbance of experimental samples will be plotted to determine concentration. Data will be synthesized using SoftMax Pro v7.1 and analyzed using Microsoft Excel v2405 and GraphPad v10.2.2.
Measured: Baseline (pre-OMT intervention), and 5-minutes, 30-minutes, and 60-minutes post-OMT
TNF-α Concentration (pg/mL)
Serum TNF-α concentration (pg/mL) will be determined using ELISA assays conducted in triplicate using human ELISA Kits from Millipore Sigma according to manufacturer's directions. Cytokine standards will be used to generate a standard curve, and mean absorbance of experimental samples will be plotted to determine concentration. Data will be synthesized using SoftMax Pro v7.1 and analyzed using Microsoft Excel v2405 and GraphPad v10.2.2.
Measured: Baseline (pre-OMT intervention), and 5-minutes, 30-minutes, and 60-minutes post-OMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start15 Sep 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- One group, single-center, non-randomized, pilot evaluation of a one-time brief (10-min) intervention of osteopathic manipulative treatment (OMT) intervention to measure effects on inflammation (TNF-α, IL-6, IL-1β, and IL-10) in healthy adult volunteers.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Northwest University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathaleen Briggs Early, PhD, RDN, CDCES, Principal investigator, PNWU-COM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820684
- Sponsor's protocol ID
- 2022-05
- Status last verified
- Feb 2025
- First submitted
- 16 Jan 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Investigators have very little data to share from this pilot study. Investigators collected venous blood samples from just 13 people. The study has limited demographic data (age, sex, perceived stress scores), baseline CMP, CBC, and cytokine data.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Response to OMT
- ClinicalTrials.gov ID
- NCT06820684
- Acronym / sponsor ID
- 2022-05
- Conditions
- Inflammation, Inflammatory Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Pacific Northwest University of Health SciencesUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 11 Feb 2025 (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.
Investigators will evaluate inflammation before and after an osteopathic manipulative treatment (OMT) in healthy adults, 18-59 years of age. Investigators will look at proteins in the blood called "cytokines". Cytokines can be pro-inflammatory, or anti-inflammatory. Investigators think OMT will reduce pro-inflammatory cytokines and increase anti-inflammatory cytokines. Investigators have selected 4 cytokines (out of a potential 30) that investigators believe, based on the literature, are most likely to change over a brief time period. This project will lay essential groundwork at the investigators' institution for future research where they will study the effects of OMT in persons with diabetes (DM) and diabetic peripheral neuropathy (DPN). DPN is a common complication of DM and has few treatment options. OMT has never been specifically studied as a treatment for DPN, and if this pilot study shows significant findings, future work in adults with DPN could be useful.
If investigators detect no changes in cytokines, this pilot work is still important. Investigators need to confirm selected tests are sensitive enough to pick up baseline levels of cytokines in healthy people, where there is expected to be low levels of pro-inflammatory markers (IL-6, TNF-alpha, IL-1b), and higher levels of anti-inflammatory markers (IL-10). Investigators will also use these data as comparison for future work in people with expectedly higher levels of inflammation due to diabetes with complications (e.g., DPN). If markers measured in this pilot study don't show anything, investigators can look at additional cytokines in future analyses. Lastly, it's clear that most people have chronic low-level inflammation without showing or experiencing overt disease; there is a likelihood that investigators will still detect changes, even in a healthy population.
Detailed description
Study Hypothesis:
- OMT will reduce acute pro-inflammatory markers.
- OMT will increase acute anti-inflammatory markers.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group, single-center, non-randomized, pilot evaluation of a one-time brief (10-min) intervention of osteopathic manipulative treatment (OMT) intervention to measure effects on inflammation (TNF-α, IL-6, IL-1β, and IL-10) in healthy adult volunteers.
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manipulative Treatment (OMT) | Experimental | Procedure: Osteopathic Manipulative Treatment (OMT)There will be only one arm for this study. All participants will receive the OMT intervention. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- At least 110 lbs.
- Age within stated required range of 18-59 years of age
- BMI <35
- Non-pregnant
- Generally healthy by self-report
Key exclusion criteria (18 listed)
- Not in the required age range
- Use of daily medications
- Unable or unwilling to meet the inclusion criteria
- Additional diagnostic tests or urgent/emergent procedures needed beyond study exam procedures
- Any history of vertebral artery pathology
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 Treatment (OMT)The OMT protocol will be delivered as follows: 1. Touching and applying gentle pressure to the participant's upper shoulder area (this is called Thoracic inlet direct myofascial release) 2. Touching and applying gentle pressure to the participant's midsection and abdomen (this is called Abdominal diaphragm direct myofascial release) 3. Touching and applying gentle pressure to the participant's pelvis and sacrum (this is called Muscle Energy or Counterstrain, if indicated). 4. Touching and applying gentle pressure to the participant's hips and hamstrings (this is called muscle energy) and will be done in 3 repeated rounds of 5 seconds each. 5. Touching and applying gentle pressure to the backs of the participant's knees (this is called open popliteal fossa with direct myofascial release) 6. Touching and applying gentle pressure to the participant's feet, moving them back and forth in 10 rhythmic pulses (this is called Pedal Pump) | Procedure or surgery | Osteopathic Manipulative Treatment (OMT) |
Primary outcome
IL-10 Concentration (pg/mL)
Time frame: Baseline (pre-OMT intervention), and 5-minutes, 30-minutes, and 60-minutes post-OMT
Serum IL-10 concentration (pg/mL) will be determined using ELISA assays conducted in triplicate using human ELISA Kits from Millipore Sigma according to manufacturer's directions. Cytokine standards will be used to generate a standard curve, and mean absorbance of experimental samples will be plotted to determine concentration. Data will be synthesized using SoftMax Pro v7.1 and analyzed using Microsoft Excel v2405 and GraphPad v10.2.2.
IL-6 Concentration (pg/mL)
Time frame: Baseline (pre-OMT intervention), and 5-minutes, 30-minutes, and 60-minutes post-OMT
Serum IL-6 concentration (pg/mL) will be determined using ELISA assays conducted in triplicate using human ELISA Kits from Millipore Sigma according to manufacturer's directions. Cytokine standards will be used to generate a standard curve, and mean absorbance of experimental samples will be plotted to determine concentration. Data will be synthesized using SoftMax Pro v7.1 and analyzed using Microsoft Excel v2405 and GraphPad v10.2.2.
IL-1β Concentration (pg/mL)
Time frame: Baseline (pre-OMT intervention), and 5-minutes, 30-minutes, and 60-minutes post-OMT
Serum IL-1β concentration (pg/mL) will be determined using ELISA assays conducted in triplicate using human ELISA Kits from Millipore Sigma according to manufacturer's directions. Cytokine standards will be used to generate a standard curve, and mean absorbance of experimental samples will be plotted to determine concentration. Data will be synthesized using SoftMax Pro v7.1 and analyzed using Microsoft Excel v2405 and GraphPad v10.2.2.
TNF-α Concentration (pg/mL)
Time frame: Baseline (pre-OMT intervention), and 5-minutes, 30-minutes, and 60-minutes post-OMT
Serum TNF-α concentration (pg/mL) will be determined using ELISA assays conducted in triplicate using human ELISA Kits from Millipore Sigma according to manufacturer's directions. Cytokine standards will be used to generate a standard curve, and mean absorbance of experimental samples will be plotted to determine concentration. Data will be synthesized using SoftMax Pro v7.1 and analyzed using Microsoft Excel v2405 and GraphPad v10.2.2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No. Investigators have very little data to share from this pilot study. Investigators collected venous blood samples from just 13 people. The study has limited demographic data (age, sex, perceived stress scores), baseline CMP, CBC, and cytokine data.
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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. This study is not recruiting at the moment.
Kathaleen Briggs Early, PhD, RDN, CDCES principal investigator
PNWU-COM
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 (OMT) in people with Inflammation and Inflammatory Response, run by Pacific Northwest University of Health Sciences 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 19 inclusion and 18 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: finished, as of the sponsor's last update on 11 Feb 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IL-10 Concentration (pg/mL) (time frame: Baseline (pre-OMT intervention), and 5-minutes, 30-minutes, and 60-minutes post-OMT). The study lists 4 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 11 Feb 2025.