Effects of Osteopathic Manipulative Therapy on Arrhythmias

NCT04004741 | Completed

• 1 other identifier: BHS-1464
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrhythmia

Keywords

Osteopathic Manipulative Medicine

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Osteopathic Manipulative Treatment

EXPERIMENTAL

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

Light Touch Treatment

SHAM COMPARATOR

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

Interventions

Osteopathic Manipulative Treatment PROCEDURE

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.

Osteopathic Manipulative Treatment

Light Touch Therapy PROCEDURE

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.

Light Touch Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York Institute of Technology: lead

Study Sites (1)

New York Institute of Technology's Academic Health Care Center

Glen Head, New York, 11545, United States

Location

Related Publications (6)

• 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.

  PMID: 29861222 BACKGROUND

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

  PMID: 25737133 BACKGROUND

• 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.

  PMID: 28460828 BACKGROUND

• 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.

  PMID: 9874066 BACKGROUND

• 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.

  PMID: 26300719 RESULT

• Nikakis J, Tale E, Malkov D, Arora US, Keys J, Li TS, Yao SC, Cohen TJ. The effect of osteopathic manipulative treatment on quality of life in patients with cardiac implantable electronic devices. J Osteopath Med. 2024 Apr 19;124(8):365-368. doi: 10.1515/jom-2023-0218. eCollection 2024 Aug 1.

  PMID: 38632892 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Todd Cohen, MD

  New York Institute of Technology College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: July 2, 2019
• Study Start: June 4, 2019
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)