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The Effects of Osteopathic Manipulative Treatment on Cardiac Arrhythmias in Patients with Cardiovascular Implantable Electronic Devices: A Randomized Controlled Trial

Journal: Journal of Osteopathic Medicine Date: 2023/12, 123(12):Pages: A69. doi: Subito , type of study: randomized controlled trial

Full text    (https://www.degruyter.com/document/doi/10.1515/jom-2023-2000/html)

Keywords:

arrhythmia [2]
cardiovascular implantable electronic devices [1]
CIED [1]
heartbeat [1]
OMT [2951]
osteopathic manipulative treatment [2973]
randomized controlled trial [710]

Abstract:

Statement of Significance: Osteopathic manipulative treatment (OMT) techniques can affect the autonomic nervous system. Previously, we reported on the effects of OMT in patients with cardiovascular implantable electronic devices (CIEDs) as assessed by a quality-of-life survey and demonstrated statistically significant improvement in activities of daily living.(1) To assess the effects of OMT on arrhythmias as recorded by CIEDs via a randomized controlled trial (RCT). Research Methods: Cardiac patients with CIEDs were recruited to participate in a double-blind randomized controlled trial approved by an osteopathic medical school’s institutional review board (ClinicalTrials.gov ID: NCT0400474). Patients who consented to the trial were prospectively randomized to either OMT or light-touch (control) groups. All interventions were performed by board-certified OMM faculty. All patients were diagnosed for somatic dysfunctions in the following regions: cervical, thoracic and lumbar spine, cranium, rib cage, sacrum, and pelvis. The OMT protocol utilized cranial osteopathy, myofascial release, rib raising, and facilitated positional release. Significant arrhythmias included atrial fibrillation (AF), atrial flutter, atrial tachycardia (AT), supraventricular tachycardia (SVT), ventricular tachycardia (VT), and ventricular fibrillation (VF). The primary outcome was a change in the number of arrhythmias within the 30-days post intervention compared to 30-days prior to intervention. Statistical analysis included a Student t-test; p < 0.05 was statistically significant. Data Analysis: 41 subjects were enrolled in the study; one was lost to follow-up (22 OMT/18 control). There were no adverse effects from either OMT or light touch during the trial. Effects of OMT on arrhythmias were as follows: 5 increased, 5 decreased, and 12 had no change from prior to intervention. Effects of light touch on arrhythmias were as follows: 5 decreased and 13 had no change. The data for specific arrhythmias were as follows (number of events pre/post intervention): SVT OMT 2/1, SVT control 1/0, AT OMT 0/0, AT control 1/1, atrial flutter OMT 0/1, atrial flutter control 0/0, AF OMT 1/2, AF control 1/1, VT OMT 3/3, VT control 1/1, VF OMT 0/0, VF control 1/1. There was no significant change in the overall number of arrhythmias between the two groups (P = 0.14). Conclusion: This is the first RCT to assess the effects of OMT on cardiac arrhythmias in CIED patients. There were no significant pro- or antiarrhythmic effects of either OMT or light-touch OMT were observed within 30 days of intervention. This study provides additional data supporting the safety of OMT with respect to cardiac arrhythmias in patients with CIEDs. Additional RCTs in a larger population are necessary to determine any cause-and-effect relationship between OMT and arrhythmias in patients with CIEDs.


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