Recruiting

Osteopathic Manipulative Treatment

Sponsor:

Burrell College of Osteopathic Medicine

Code:

NCT04177264

Conditions

Inflammation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Occipito-Atlantal Decompression (OA DC)

Sham Occipito-Atlantal Decompression (Sham OA DC)

Splenic Lymphatic Pump Technique (SpLPT)

Sham Splenic Lymphatic Pump Technique (Sham SpLPT)

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Study Details

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.

Conditions

Inflammation

Study ID

NCT04177264

Start date

Jan 6, 2020

Status verified date

Feb, 2023

Completion date

Aug, 2023

Anticipated

Primary completion date

Aug, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age of 18 year or above.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Osteopathic Manipulative Treatment (OMT)

In 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.

experimental: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

In 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.

no intervention: Time Control

In 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

Occipito-Atlantal Decompression (OA DC)

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.

Sham Occipito-Atlantal Decompression (Sham OA DC)

The participant lies supine in a relaxed state while the investigator applies light touch to the patient's head with their hands.

Splenic Lymphatic Pump Technique (SpLPT)

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.

Sham Splenic Lymphatic Pump Technique (Sham SpLPT)

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.

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

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.

Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS)

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.

Primary outcome measure

  • Effect of the Interventions on Inflammation [ Time Frame: 2 days ]

Central Contacts and Locations

Central contacts

Harald M Stauss, MD, PhD

575-674-2327hstauss@bcomnm.org

Locations

Burrell College of Osteopathic Medicine

Recruiting

Las Cruces, New Mexico, United States, 88001

Contacts

Harald M Stauss, MD, PhD

575-674-2327hstauss@bcomnm.org

More Information

Sponsor

Burrell College of Osteopathic Medicine

Last update posted

Feb 8, 2023

Last verified

Feb, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Burrell College of Osteopathic Medicine on 2023-02-08.