NCT06820684

Inflammatory Response to OMT

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Pacific Northwest University of Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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.

Conditions

• Inflammation
• Inflammatory Response

Interventions

Type	Name	Description
PROCEDURE	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)

Timeline

• Start date: 2022-09-15
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2025-02-11
• Last updated: 2025-02-11

Locations

1 site across 1 country: United States