Osteopathic Manipulative Treatment for Arrhythmias, Cardiac

Phase-Based Estimates
1
Effectiveness
1
Safety
New York Institute of Technology's Academic Health Care Center, Glen Head, NY
Arrhythmias, Cardiac+1 More
Osteopathic Manipulative Treatment - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Arrhythmias, Cardiac

Study Summary

This study is evaluating whether Osteopathic manipulative medicine (OMM) can reduce the number of cardiac events experienced by patients with an implanted cardiac device.

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Eligible Conditions

  • Arrhythmias, Cardiac
  • Arrhythmia

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Osteopathic Manipulative Treatment will improve 1 primary outcome in patients with Arrhythmias, Cardiac. Measurement will happen over the course of 1 month from enrollment..

1 month from enrollment.
Decrease in Cardiac Events

Trial Safety

Trial Design

2 Treatment Groups

Light Touch Treatment
Osteopathic Manipulative Treatment
Placebo group

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Osteopathic Manipulative Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Osteopathic Manipulative Treatment
Procedure
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.
Light Touch Treatment
Procedure
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osteopathic Manipulative Treatment
2008
Completed Phase 4
~2450

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month from enrollment.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 month from enrollment. for reporting.

Closest Location

New York Institute of Technology's Academic Health Care Center - Glen Head, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A person who has a device implanted in them and is connected to either CareLink, Merlin, or a respective web-based monitoring device for at least one month is considered to be a subject for this study. show original
If the subject has been prescribed anticoagulants, they have been taking them for at least one month prior to the intervention. show original
The subject has not been convicted of a felony The subject is at least 18 years of age and has not been convicted of a felony. show original
The subject has a documented diagnosis of a controlled arrhythmia. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can arrhythmias, cardiac be cured?

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Arrhythmias can not be cure, but their symptoms can be practically improved or even eliminated, depending on the individual's condition. Arrhythmias that occur only in certain circumstances or at certain periods can be treated well. For instance, patients with ventricular tachycardia can be effectively controlled and even cured even if they do not have a history of the condition. However, arrhythmias, cardiac can not be cured. Atrial fibrillation, in particular, cannot be cured because it always stays with the heart, and it is impossible to completely stop it. Even with a good anticonvulsant, the arrhythmia, cardiac can not be cured.

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How many people get arrhythmias, cardiac a year in the United States?

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There are approximately 3.7 million people with cardiac arrhythmia annually in the United States. Of these, more than 2.5 million have at least a minor degree of cardiac dysfunction which may require medical management.

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What are the signs of arrhythmias, cardiac?

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An assessment of the physical exam, medical history, and cardiac history helps to formulate a differential diagnosis. The diagnosis can be made after consultation with a cardiologist.

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What causes arrhythmias, cardiac?

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Arrhythmias occur because of electrical problems with the heart or other problems with the conduction system. Cardiac diseases can cause arrhythmias that can lead to fainting or death. Arrhythmias often occur because of structural problems or problems with the conduction system of the heart.

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What are common treatments for arrhythmias, cardiac?

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While a variety of treatments exist, there is no cure for any form of arrhythmia. Treatment is tailored to the particular arrhythmia, and most commonly involves medications to control ventricular tachycardia or atrial fibrillation as well as control symptoms, such as palpitations, lightheadedness, and fatigue, which in many individuals can severely limit day-to-day function. Ventricular tachycardia can be treated with medications such as procainamide or amiodarone, while atrial fibrillation can be treated with medications such as sotalol or warfarin. Ablation of atria or ventricles is another treatment option, but can lead to complications including stroke.

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What is arrhythmias, cardiac?

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Arrhythmias are a form of arrhythmia in which the heart beats too quickly or too slowly. Arrhythmias can cause fainting, shortness of breath and palpitations or result in atrial fibrillation. Most arrhythmias involve the sinus node. It is a cardiographic finding that can be used clinically to predict the risk of atrial fibrillation. We used these criteria to determine the prevalence of arrhythmia in an ED medical admissions and found a prevalence of 13%. Arrhythmias are common presentations for emergency physicians. Clinical practice guidelines for the assessment, management and monitoring of arrhythmias in ED patients are now established.

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What are the common side effects of osteopathic manipulative treatment?

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Patients receiving OMT showed a greater frequency of common side effects when compared to their frequency of side effects in all controls (p = 0.025).

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What are the latest developments in osteopathic manipulative treatment for therapeutic use?

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The current advances in the field of medicine, especially in orthopaedics, are improving the clinical indications for OMT, so that it may be considered as a therapeutic option for a wide range of musculoskeletal disorders like osteoarthritis or rheumatoid arthritis. OMT as a specific medical and rehabilitation therapy is a new trend.

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Is osteopathic manipulative treatment safe for people?

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There is no evidence that patients undergoing OMT have a higher risk of adverse events compared with other outpatient medical treatments and no increased risk of cardiac complications compared to other therapies. OMT has not been shown to be associated with an increase in cardiac complications; thus, this treatment may not be dangerous.

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What is the primary cause of arrhythmias, cardiac?

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The primary cause of arrhythmias, congestive heart failure, is prevalent in this population. Other causes of arrhythmias were seen in the majority, including cardiolectal (31%), noncardiolectal (31%), ischemic (9%), infectious (1%), and congenital (1%) causes. Although rare, the primary cause of arrhythmia was identified in a significant number of patients.

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Has osteopathic manipulative treatment proven to be more effective than a placebo?

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The use of a placebo in MMT/OMT is not recommended. It is not known if MMT/OMT may be better than exercise plus massage in the treatment of cardiac hypertrophy.

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How does osteopathic manipulative treatment work?

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An overall tendency for a shortening of QT interval dispersion by EMG after EMG-only was found. The mechanism underlying these observations may be related to the improved cardiac autonomic modulation known to occur in osteopathic manipulative therapy. Therefore, caution should be used when the osteopathic manipulation involves the cardiac system.

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