Clinical trial NCT04004741: Effects of Osteopathic Manipulative Therapy on Arrhythmias
Official title: Effects of Osteopathic Manipulative Therapy on Arrhythmias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrhythmia
Keywords: Osteopathic Manipulative Medicine
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Decrease in Cardiac Events
timeFrame: 1 month from enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Glen Head
country: United States
facility: New York Institute of Technology's Academic Health Care Center
state: New York
Study officials:
affiliation: New York Institute of Technology College of Osteopathic Medicine
name: Todd Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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: randomized controlled trial. Front Neurosci. 2015 Aug 4;9:272. doi: 10.3389/fnins.2015.00272. eCollection 2015.