Osteopathic Manipulative Treatment for Arrhythmia

Overseen By Alyssa M Auerbach

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New York Institute of Technology

Must be taking: Anticoagulants

Disqualifiers: Planned surgeries, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 session

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how osteopathic manipulative treatment, a hands-on therapy focusing on muscles and bones, might affect arrhythmias, which are irregular heartbeats. Participants will receive either this treatment or a light touch treatment, a gentle, non-invasive therapy, to observe any changes in heart rhythm. The trial seeks individuals with a controlled arrhythmia who use an implanted device to monitor their heart. Those managing their arrhythmia with such a device may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to understanding new treatment approaches for arrhythmias.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that your treatment regimen, including medications, remains unchanged for the next month.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that osteopathic manipulative treatment (OMT) is generally safe for patients. OMT uses hands-on techniques to diagnose and treat various conditions and is usually well-tolerated. Some studies provide a way to measure potential risks, but serious side effects rarely occur.

Patients might feel mild soreness after OMT, similar to post-exercise soreness. However, studies have not reported any severe side effects. Overall, this treatment appears to be a safe option for those considering participation in such trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring osteopathic manipulative therapy (OMT) for arrhythmias because it offers a non-invasive approach that targets the body's musculoskeletal system to potentially influence heart rhythms. Unlike standard treatments that often involve medications or invasive procedures, OMT uses manual techniques to address potential triggers for arrhythmias, such as by releasing tension in specific areas like the ribs and thoracic region. This hands-on method might help identify and treat specific points that contribute to irregular heartbeats, offering a unique pathway to manage arrhythmias without the side effects that can come with drug therapy.

What evidence suggests that this trial's treatments could be effective for arrhythmia?

Research has shown that osteopathic manipulative treatment (OMT), which participants in this trial may receive, can affect the part of the nervous system that controls the heart. Some studies have found changes in heart rate variability (HRV) after OMT. HRV measures how well the heart handles stress and relaxation. However, other studies did not find a significant change in irregular heartbeats, known as arrhythmias, after OMT. This suggests that while OMT might change heart rate patterns, its effect on reducing arrhythmias remains uncertain. More research is needed to confirm its impact on arrhythmias. Another group in this trial will receive Light Touch Treatment, serving as a sham comparator to help evaluate the effects of OMT. ^{6 7 8 9 10}

Who Is on the Research Team?

Todd Cohen, MD

Principal Investigator

New York Institute of Technology College of Osteopathic Medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either Osteopathic Manipulative Treatment or Light Touch Treatment for 25 minutes

1 session

1 visit (in-person)

Follow-up

Participants are monitored for changes in cardiac events using the CareLink system

4 weeks

Remote monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Light Touch Therapy
• Osteopathic Manipulative Treatment

How Is the Trial Designed?

Group I: Osteopathic Manipulative Treatment Experimental Treatment 1 Intervention

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.

Group II: Light Touch Treatment Placebo Group 1 Intervention

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.

Osteopathic Manipulative Treatment is already approved in United States, European Union for the following indications:

Approved in United States as OMT for:

• Positional plagiocephaly
• Deformational plagiocephaly

Approved in European Union as OMT for:

• Positional plagiocephaly
• Deformational plagiocephaly

Who Is Running the Clinical Trial?

New York Institute of Technology

Lead Sponsor

Trials

56

Recruited

2,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7575744/

Exploring the Effects of Osteopathic Manipulative Treatment ... Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1360859224000032

The effectiveness of an osteopathic manual technique ... The effectiveness of an osteopathic manual technique compared with a breathing exercise on vagal tone as indicated by heart rate variability, a crossover study.

3. innovationsincrm.com innovationsincrm.com/cardiac-rhythm-management/articles-2024/december/2268-the-effects-of-osteopathic-manipulative-treatment-on-arrhythmias

The Effects of Osteopathic Manipulative Treatment on ... No significant change in arrhythmia burden was found in the 1 month following intervention (P = .14). Discrete heart rate (HR), HR variability (HRV), and ...

4. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2020.00887/full

Does Osteopathic Manipulative Treatment Induce ... The present research supports the hypothesis that a single session of OMT as compared to sham induces autonomic consequences in healthy non-symptomatic adults.

5. researchgate.net researchgate.net/publication/346113390_Exploring_the_Effects_of_Osteopathic_Manipulative_Treatment_on_Autonomic_Function_Through_the_Lens_of_Heart_Rate_Variability

(PDF) Exploring the Effects of Osteopathic Manipulative ... Heart rate variability (HRV) is an important physiological measure of cardiac ANS activity. Emerging evidence suggests that OMT is associated with HRV changes ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10642050/

Defining the landscape of patient harm after osteopathic ... Third, we report a patient safety benchmark against which future trials and quality improvement studies in the field of osteopathic manipulative ...

7. uhcprovider.com uhcprovider.com/content/dam/provider/docs/public/policies/medadv-mp/osteopathic-manipulations-omt.pdf

Osteopathic Manipulations (OMT) Overview. Osteopathic manipulative treatment (OMT) is a treatment employed, primarily by osteopathic physicians, to facilitate a.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9021775/

Efficacy and safety of osteopathic manipulative treatment To summarise the available clinical evidence on the efficacy and safety of osteopathic manipulative treatment (OMT) for different conditions.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04976985

Osteopathic Manipulative Treatment and Migraine ... Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, non-invasive form of manual medicine. Headache has been shown to be associated with impairment ...

10. osteopathicboard.org osteopathicboard.org/wp-content/uploads/2020/09/The-Pocket-Manual-of-OMT-Osteopathic-Manipulative-Treatment-for-Physicians.pdf

Pocket Manual of OMT Department of Osteopathic Manipulative Medicine. Biddeford, Maine ... Osteopathic manipulative treatment (OMT) is used to treat a patient's problem associ-.