Inflammatory Response to OMT

Not Applicable

Completed

• Conditions: Inflammation; Inflammatory Response

• Registration Number: NCT06820684
• Lead Sponsor: Pacific Northwest University of Health Sciences

Brief 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. 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:

1. OMT will reduce acute pro-inflammatory markers.

2. OMT will increase acute anti-inflammatory markers.

Study Timeline

• Study Start: 2022-09-15
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Study First Submitted: 2025-01-16
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
IL-10 Concentration (pg/mL)	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)	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)	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)	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.

Trial Locations

Locations (1)

Pacific Northwest University of Health Sciences (PNWU); 🇺🇸 Yakima, Washington, United States