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The Short-Term and Long-Term Physiologic Effects of Osteopathic Manipulative Treatment in Patients with Cardiac Implantable Electronic Devices: A Randomized Controlled Trial

Journal: Heart Rhythm Date: 2023/05, 20(5):Pages: S258. doi: Subito , type of study: randomized controlled trial

Full text    (https://www.heartrhythmjournal.com/article/S1547-5271(23)01012-3/fulltext)

Keywords:

cardiac implantable electronic device [2]
conference abstract [108]
heart rate [63]
OMT [2951]
osteopathic manipulative treatment [2973]
randomized controlled trial [710]

Abstract:

Background: Certain osteopathic manipulative treatment (OMT) techniques have been shown to affect the autonomic nervous system (ANS). We previously assessed ultra-short-term effects of OMT (within 5 minutes pre and post intervention) on physiologic parameters such as heart rate (HR), respiratory rate (RR), arterial blood pressure (BP), oxygen saturation (Sp02) and heart rate variability (HRV) in patients with CIEDs (Cardiac Implantable Electronic Devices). All of these parameters except for blood pressure had been measured with the use of photoplethysmography. Objective: To assess the short-term and long-term physiologic effects of OMT on heart rate, HRV and activities of daily living in patients with CIEDs utilizing their internal ECG recording system and data. Methods: Cardiac patients with CIEDs at an osteopathic medical center were recruited into a randomized controlled trial (ClinicalTrials.gov ID: NCT0400474) and assigned to either OMT or light touch (control) groups. Short-term and long-term physiologic data were recorded by the existing CIEDs and retrieved from the raw data repository kept by Medtronic (Dublin, Ireland). The data provided included day and night heart rate, HRV and activities of daily living. Daily values were retrieved for 1, 3, 7, 14 and 30 days pre- and post-intervention and compared between the groups. Student’s t-test was used to compare the groups; α=0.05. Results: 41 subjects were enrolled in the study. Since the discrete data were only available for devices that were enrolled in CareLink at the time of the request, the data were available only for 17 of the subjects (10 OMT/7 control). Table 1 shows average changes in physiologic measurements pre and post intervention. There was no statistically significant difference in changes in heart rate, HRV and activities of daily living between the groups, however HRV changes showed a similar trend to that observed in our ultra-short-term analysis: an increase of HRV in the control group and a decrease in the OMT group. Conclusion: This is the first RCT to investigate the short- and long-term physiologic effects of OMT in patients with CIEDs. Although not statistically significant, HRV recorded electrocardiographically by CIEDs tended to decrease following the OMT and increase following light touch similar to the findings we observed with plethysmography during the ultra-short-term analysis in this patient population. Additional studies are necessary to determine whether these trends are statistically significant in the larger cohort. [Formula presented]


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