Anti-inflammatory Actions of Osteopathic Manipulative Treatment
OMT_taVNS
1 other identifier
interventional
36
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2019
CompletedFirst Posted
Study publicly available on registry
November 26, 2019
CompletedStudy Start
First participant enrolled
January 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedFebruary 8, 2023
February 1, 2023
3.6 years
November 21, 2019
February 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of the Interventions on Inflammation
The effect of the interventions on inflammation is assessed by plasma levels of pro- and anti-inflammatory cytokines; activation or inactivation of immune cells in the blood; and release of cytokines from TLR-ligand-activated immune cell cultures. All of these inflammatory measures will be determined from blood samples collected on the third study day and therefore, reflect the cumulative effect of the three study days.
2 days
Secondary Outcomes (2)
Change in Autonomic Nervous System Function Induced by the Interventions
110 minutes
Cumulative Effect of the Interventions on Autonomic Nervous System Function
2 days
Study Arms (3)
Osteopathic Manipulative Treatment (OMT)
EXPERIMENTALIn 4 randomized study sessions, combinations of two different osteopathic manipulative treatment (OMT) techniques (occipito-atlantal decompression \[OA DC\] and splenic lymphatic pump technique \[SpLPT\]) or their respective sham interventions will be performed. The 4 study sessions are at least one month apart and consist of 3 consecutive study days on which the same combination of OMT techniques or sham interventions will be performed.
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
EXPERIMENTALIn 4 randomized study sessions, combinations of non-invasive transcutaneous auricular vagus nerve stimulation (taVNS), osteopathic splenic lymphatic pump technique (SpLPT) or their respective sham interventions will be performed. The 4 study sessions are at least one month apart and consist of 3 consecutive study days on which the same combination of taVNS, SpLPT, or sham interventions will be performed.
Time Control
NO INTERVENTIONIn 4 study sessions, no intervention will be performed. As with the two experimental arms, the 4 study sessions are at least one month apart and consist of 3 consecutive study days on which no intervention will be performed. This arm serves as a time control group.
Interventions
The participant lies supine in a relaxed state while the investigator cradles the patient's head with their hands, middle finger pads along the inferior aspect of inion, reaching to the occipito-atlantal joint. The investigator then applies gentle posterior and cephalad traction to the occiput, while bringing the elbows together. This results in supination of the hands and separation of the middle fingers, creating a posterior-lateral force vector to either side of the foramen magnum. The pressure is maintained until softening of the underlying structures is felt. The procedure is applied for 10 minutes.
The participant lies supine in a relaxed state while the investigator applies light touch to the patient's head with their hands.
With the participant supine, the investigator places a posterior hand along the left lower ribcage, and a superior hand over the left costal arch, encompassing the spleen. The investigatory compresses and releases the spleen at a rate of 20 compressions/min for 3 min.
With the participant supine, the investigator places a posterior hand along the left lower ribcage, and a superior hand over the left costal arch, encompassing the spleen. The investigator will maintain light touch at these positions for 3 minutes. No compressions are performed.
A bipolar clip electrode is attached to the auricle at the location of the cymba conchae. Electrical stimulation (30 Hz stimulation frequency, 300 μs pulse width) is applied for 10 min. The stimulation current is determined individually for each participant by slowly increasing the stimulation current until the participants feel a mild tingling sensation at the site of the electrode. Then the current is gradually reduced until the tingling sensation disappears. This current will then be used for taVNS. A TENS 7000 or EMS 7500 device (510(k): K080661) is used.
A bipolar clip electrode is attached to the auricle at the location of the cymba conchae but no electrical current is applied to the electrode.
Eligibility Criteria
You may qualify if:
- Age of 18 year or above.
You may not qualify if:
- Age under 18 years
- Pregnancy
- Any findings on the osteopathic screening/evaluation that would hinder the effectiveness - of the occipito-atlantal decompression or splenic lymphatic pump technique
- Any medication that interferes with the autonomic nervous system function or the immune system (e.g., beta-blockers, steroids, TNF-α inhibitors)
- 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)
- Any chronic diseases, such as diabetes and hypertension
- Current drug or alcohol abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Burrell College of Osteopathic Medicine
Las Cruces, New Mexico, 88001, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harald M Stauss, MD, PhD
Burrell College of Osteopathic Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- There is no masking. The nature of the intervention makes it impossible to prevent the participants from knowing what intervention will be performed on them. The investigators will be performing the interventions and, thus, cannot be masked.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pharmacology
Study Record Dates
First Submitted
November 21, 2019
First Posted
November 26, 2019
Study Start
January 6, 2020
Primary Completion
August 1, 2023
Study Completion
August 1, 2023
Last Updated
February 8, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share