Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Osteopathic Manipulative Therapy on Arrhythmias

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04004741
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
New York Institute of Technology

Brief 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.


Condition or disease Intervention/treatment Phase
Cardiac Arrhythmia Procedure: Osteopathic Manipulative Treatment Procedure: Light Touch Therapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Osteopathic Manipulative Therapy on Arrhythmias
Actual Study Start Date : June 4, 2019
Estimated Primary Completion Date : August 28, 2019
Estimated Study Completion Date : September 25, 2019

Arm Intervention/treatment
Experimental: 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.
Procedure: 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.


Sham Comparator: 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.
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.




Primary Outcome Measures :
  1. Decrease in Cardiac Events [ Time Frame: 1 month from enrollment. ]
    The authors believe that OMT will change the number of cardiac events in arrhythmic patients, as measured on CareLink system for those with Medtronic devices, or the comparable online system for the other various manufacturers as detailed below, via the patient's implanted devices.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004741


Contacts
Layout table for location contacts
Contact: Todd J Cohen, MD 5166861300 tcohen03@nyit.edu
Contact: Alyssa M Auerbach 5164769066 aauerbac@nyit.edu

Locations
Layout table for location information
United States, New York
New York Institute of Technology's Academic Health Care Center Recruiting
Glen Head, New York, United States, 11545
Contact: Brian Harper, MD, MPH    516-686-1300    bharper@nyit.edu   
Principal Investigator: Todd J. Cohen, MD         
Sub-Investigator: Sheldon C. Yao, DO         
Sub-Investigator: George K. Cheriyan, DO         
Sponsors and Collaborators
New York Institute of Technology
Investigators
Layout table for investigator information
Principal Investigator: Todd Cohen, MD New York Institute of Technology College of Osteopathic Medicine

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: New York Institute of Technology
ClinicalTrials.gov Identifier: NCT04004741     History of Changes
Other Study ID Numbers: BHS-1464
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York Institute of Technology:
Osteopathic Manipulative Medicine

Additional relevant MeSH terms:
Layout table for MeSH terms
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes