Effects of Osteopathic Manipulative Therapy on Arrhythmias

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-04

Study Completion Date

2022-04-30

Brief Summary

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The study focuses on patients who have already been diagnosed with an arrhythmia. This is a randomized control trial that will use measurements from the implanted devices to quantify changes in the number of cardiac events experienced. Subjects will present to the Long Island Heart Rhythm Clinic (LIHRC) at the New York Institute of Technology (NYIT) Academic Health Care Center for their scheduled appointment with Dr. Cohen. These patients are generally coming in for their electrophysiology cardiology checkup, postsurgical visit, or consultation concerning their cardiac health. Once confirmed the patients meet the inclusion criteria, they will be informed about this proposed study and asked if they would like to participate. They will then be consented and randomized according to the randomization procedure outlined below.

Once enrolled, the patients will complete the study as outlined in the procedures below. They will have a baseline EKG taken, and then proceed to either Osteopathic manipulative medicine (OMM) treatment or control somatic dysfunction (SD) evaluation. The investigators will then analyze the CareLink data, or the web-based management service for the respective device, to quantify the effects the OMM or control SD evaluation had on any arrhythmia events.

All investigators delivering OMM will be neuromuscular medicine/osteopathic manipulative medicine (NMM/OMM) board certified attending physicians and trained in the specific techniques that have been associated with arrhythmia SDs and treatment modalities to have consistency when treating subjects. Subject confidentiality will be maintained throughout the process as delineated in Question 5 of the protocol document.

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Detailed Description

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Conditions

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Cardiac Arrhythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Osteopathic Manipulative Treatment

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 Type EXPERIMENTAL

Osteopathic Manipulative Treatment

Intervention Type PROCEDURE

The purpose of this research is to investigate the effect of osteopathic manipulative treatment (OMT) focused on somatic dysfunctions commonly associated with arrhythmias on the amount of quantifiable arrhythmias as recorded on a diagnostic device.

It is known that OMT has a stabilizing effect on the autonomic nervous system, which plays a key role in regulating heart rate and blood pressure. This increases parasympathetic tone and decreases sympathetic tone, which generally stabilizes the heart with an antiarrhythmic effect.

Previous work has been done showing that osteopathic treatment is a beneficial adjunctive therapy for paroxysmal atrial fibrillation and decreased symptoms, though has not been proven to be helpful for patients with heart failure.

While the effect of OMT on the neurology has been studied, we would like to further research the effect OMT specifically has on arrhythmias using more quantifiable data from implanted devices.

Light Touch Treatment

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.

Group Type SHAM_COMPARATOR

Light Touch Therapy

Intervention Type PROCEDURE

The physician will contact various areas of the body for 120 seconds each to expose the subject to a similar environment as the interventional group, without stimulating the autonomic nervous system.

Interventions

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Osteopathic Manipulative Treatment

The purpose of this research is to investigate the effect of osteopathic manipulative treatment (OMT) focused on somatic dysfunctions commonly associated with arrhythmias on the amount of quantifiable arrhythmias as recorded on a diagnostic device.

It is known that OMT has a stabilizing effect on the autonomic nervous system, which plays a key role in regulating heart rate and blood pressure. This increases parasympathetic tone and decreases sympathetic tone, which generally stabilizes the heart with an antiarrhythmic effect.

Previous work has been done showing that osteopathic treatment is a beneficial adjunctive therapy for paroxysmal atrial fibrillation and decreased symptoms, though has not been proven to be helpful for patients with heart failure.

While the effect of OMT on the neurology has been studied, we would like to further research the effect OMT specifically has on arrhythmias using more quantifiable data from implanted devices.

Intervention Type PROCEDURE

Light Touch Therapy

The physician will contact various areas of the body for 120 seconds each to expose the subject to a similar environment as the interventional group, without stimulating the autonomic nervous system.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subject is at least 18 years of age
* 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

Exclusion Criteria

* Subject planning any surgeries, device updates or changes in the next month
* Subject's treatment regimen, including any medications, will be changed in next month
* Subject has contraindications to undergo OMT, which include prior spinal surgery, prior spinal fracture, any acute fractures over regions being treated or open wounds, current infection, or any other medical conditions that would prohibit OMT
* Subject is pregnant

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No