RECRUITING

Anti-inflammatory Actions of Osteopathic Manipulative Treatment

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study evaluates the hypothesis that osteopathic manipulative treatment (OMT) and non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) elicit anti-inflammatory actions through activation of the parasympathetic nervous system. In a cross-over design, research participants will be subjected to various combinations of OMT, taVNS, or sham interventions during four study sessions, that are at least one month apart. During each study session research participants will undergo OMT and/or taVNS for 3 consecutive days. Blood pressure and electrocardiogram (ECG) will be recorded on all three study days to assess parasympathetic nervous system function. On the 3rd study day a blood sample will be taken to assess the effects of OMT and/or taVNS on inflammation.

Official Title

Anti-inflammatory Actions of OMT - Role of the Cholinergic Anti-inflammatory Pathway and Translocation of Immune Cells From Reticular Organs to the Systemic Circulation

Quick Facts

Study Start:2020-01-06
Study Completion:2023-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04177264

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age of 18 year or above.
  1. * Age under 18 years
  2. * Pregnancy
  3. * Any findings on the osteopathic screening/evaluation that would hinder the effectiveness - of the occipito-atlantal decompression or splenic lymphatic pump technique
  4. * Any medication that interferes with the autonomic nervous system function or the immune system (e.g., beta-blockers, steroids, TNF-α inhibitors)
  5. * Any medical condition that affects the autonomic nervous system or the immune system (e.g., splenomegaly, Epstein-Barr infection within the last 6 months, autonomic neuropathy, pure autonomic failure, rheumatic or autoimmune diseases, acquired autoimmune deficiency syndrome)
  6. * Any chronic diseases, such as diabetes and hypertension
  7. * Current drug or alcohol abuse.

Contacts and Locations

Study Contact

Harald M Stauss, MD, PhD
CONTACT
575-674-2327
hstauss@bcomnm.org

Principal Investigator

Harald M Stauss, MD, PhD
PRINCIPAL_INVESTIGATOR
Burrell College of Osteopathic Medicine

Study Locations (Sites)

Burrell College of Osteopathic Medicine
Las Cruces, New Mexico, 88001
United States

Collaborators and Investigators

Sponsor: Burrell College of Osteopathic Medicine

  • Harald M Stauss, MD, PhD, PRINCIPAL_INVESTIGATOR, Burrell College of Osteopathic Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-06
Study Completion Date2023-08

Study Record Updates

Study Start Date2020-01-06
Study Completion Date2023-08

Terms related to this study

Keywords Provided by Researchers

  • osteopathic manipulative treatment
  • transcutaneous auricular vagus nerve stimulation
  • cytokines
  • immune cells
  • parasympathetic nervous system
  • heart rate variability

Additional Relevant MeSH Terms

  • Inflammation