Anti-inflammatory Actions of Osteopathic Manipulative Treatment

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

Interventions

DEVICE

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.

DEVICE

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.

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

• Burrell College of Osteopathic Medicine

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-01-06

Primary Completion

2023-08-31

Completion

2023-08-31

FDA Device

Yes

Countries

• United States

Study Locations