Effects of Osteopathic Manipulative Therapy on Arrhythmias

Cardiac Arrhythmia Clinical Trial

Official title:

Effects of Osteopathic Manipulative Therapy on Arrhythmias

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04004741
• Other study ID #: BHS-1464
• Status: Completed
• Phase: N/A
• Start date: June 4, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: April 2023
• Source: New York Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York Institute of Technology's Academic Health Care Center	Glen Head	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Institute of Technology

Country where clinical trial is conducted

United States, 

References & Publications (5)

Berger M, Schweitzer P. Timing of thromboembolic events after electrical cardioversion of atrial fibrillation or flutter: a retrospective analysis. Am J Cardiol. 1998 Dec 15;82(12):1545-7, A8. doi: 10.1016/s0002-9149(98)00704-8. — View Citation

Fu DG. Cardiac Arrhythmias: Diagnosis, Symptoms, and Treatments. Cell Biochem Biophys. 2015 Nov;73(2):291-296. doi: 10.1007/s12013-015-0626-4. — View Citation

Kirchhof P. The future of atrial fibrillation management: integrated care and stratified therapy. Lancet. 2017 Oct 21;390(10105):1873-1887. doi: 10.1016/S0140-6736(17)31072-3. Epub 2017 Apr 28. Erratum In: Lancet. 2017 Oct 21;390(10105):1832. Dosage error in article text. — View Citation

Ruffini N, D'Alessandro G, Mariani N, Pollastrelli A, Cardinali L, Cerritelli F. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: — View Citation

Thomaz SR, Teixeira FA, de Lima ACGB, Cipriano Junior G, Formiga MF, Cahalin LP. Osteopathic manual therapy in heart failure patients: A randomized clinical trial. J Bodyw Mov Ther. 2018 Apr;22(2):293-299. doi: 10.1016/j.jbmt.2017.07.011. Epub 2017 Jul 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in Cardiac Events	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.	1 month from enrollment.