Effects of Osteopathic Manipulative Therapy on Arrhythmias

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    40
  • sponsor
    New York Institute of Technology
Updated on 11 February 2022
electrocardiogram
heart failure
anticoagulants
arrhythmia
cardiac event
fibrillation
antiarrhythmic drug

Summary

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.

Details
Condition Cardiac Arrhythmia
Treatment Osteopathic Manipulative Treatment, Light Touch Therapy
Clinical Study IdentifierNCT04004741
SponsorNew York Institute of Technology
Last Modified on11 February 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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