Inflammatory Response to OMT

NCT06820684 | Completed

• 1 other identifier: 2022-05
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Inflammatory Response

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline (pre-OMT intervention), and 5-minutes, 30-minutes, and 60-minutes post-OMT

Study Arms (1)

Osteopathic Manipulative Treatment (OMT)

EXPERIMENTAL

There will be only one arm for this study. All participants will receive the OMT intervention.

Procedure: Osteopathic Manipulative Treatment (OMT)

Interventions

Osteopathic Manipulative Treatment (OMT) PROCEDURE

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)

Osteopathic Manipulative Treatment (OMT)

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Not in the required age range
• Use of daily medications
• 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)

Sponsors & Collaborators

• Pacific Northwest University of Health Sciences: lead

Study Sites (1)

Pacific Northwest University of Health Sciences (PNWU)

Yakima, Washington, 98901, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Kathaleen Briggs Early, PhD, RDN, CDCES

  PNWU-COM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: February 11, 2025
• Study Start: September 15, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)