Effects of Osteopathic Manipulative Therapy on Arrhythmias

Last updated: April 5, 2023
Sponsor: New York Institute of Technology
Overall Status: Completed

Phase

N/A

Condition

Fast Heart Rate (Tachycardia)

Circulation Disorders

Atrial Fibrillation

Treatment

N/A

Clinical Study ID

NCT04004741
BHS-1464
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is at least 18 years of age
  • Subject has an implanted device connected to CareLink, Merlin, or respective web-basedmonitoring 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 forat least one month prior to intervention

Exclusion

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

Study Design

Total Participants: 42
Study Start date:
June 04, 2019
Estimated Completion Date:
April 30, 2022

Connect with a study center

  • New York Institute of Technology's Academic Health Care Center

    Glen Head, New York 11545
    United States

    Site Not Available

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