Effects of Osteopathic Manipulative Therapy on Arrhythmias

Overseen By Alyssa M Auerbach

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New York Institute of Technology

Must be taking: Anticoagulants

Disqualifiers: Planned surgeries, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 session

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a hands-on treatment called Osteopathic Manipulative Medicine (OMM) on patients with irregular heartbeats. The goal is to see if this treatment can reduce the number of irregular heartbeats by improving overall body function. Patients will receive either the OMM treatment or another type of evaluation to compare the results.

Who Is on the Research Team?

Todd Cohen, MD

Principal Investigator

New York Institute of Technology College of Osteopathic Medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject has an implanted device connected to CareLink, Merlin, or respective web-based monitoring device, for at least one month

Subject has documented diagnosis of a controlled arrhythmia

If subject has been prescribed anticoagulants, the patients has been taking them for at least one month prior to intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either Osteopathic Manipulative Treatment or Light Touch Treatment for 25 minutes

1 session

1 visit (in-person)

Follow-up

Participants are monitored for changes in cardiac events using the CareLink system

4 weeks

Remote monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Light Touch Therapy
• Osteopathic Manipulative Treatment

How Is the Trial Designed?

Group I: Osteopathic Manipulative Treatment Experimental Treatment 1 Intervention

Group A will receive osteopathic treatment by NMM/OMM board certified attending physicians. The protocol for the OMT intervention group is based on the guidelines set forth previously in textbooks. The protocol will last 25 minutes total, with 10 minutes for the evaluation and 15 minutes for treatment. The protocol will start in ribs so as to not exacerbate any tachyarrhythmias with rib raising, thoracic myofascial release, and a pectoralis lift. The investigator will then proceed with opening the thoracic inlet, cervical myofascial release, suboccipital release, and then end by checking for and treating Chapman's points. The physician will submit their osteopathic evaluation and fill out a form in order to determine if certain arrhythmias have an associated trigger point.

Group II: Light Touch Treatment Placebo Group 1 Intervention

Group B will receive a light touch treatment, based on previous research done studying heart rate variability and OMM, where sham treatment was utilized. The protocol consisted of contacting the right ankle, left knee, right hip, diaphragm, right shoulder, neck, and cranium for precisely two minutes each, with the goal of preventing placebo autonomic nervous system stimulation. The protocol is 25 minutes long, with 10 minutes for the evaluation and 15 minutes for treatment.

Osteopathic Manipulative Treatment is already approved in United States, European Union for the following indications:

Approved in United States as OMT for:

• Positional plagiocephaly
• Deformational plagiocephaly

Approved in European Union as OMT for:

• Positional plagiocephaly
• Deformational plagiocephaly

Who Is Running the Clinical Trial?

New York Institute of Technology

Lead Sponsor

Trials

56

Recruited

2,300+