Journal of Osteopathic Medicine, 2024/08, 124(8):365-368. doi: 10.1515/jom-2023-0218, type of study: ,rct,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,

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Keywords:

cardiac implantable electronic devices [2]
CIED [3]
OMT [3924]
osteopathic manipulative treatment [3945]
quality of life [126]
randomized controlled trial [947]

Abstract:

CONTEXT: Osteopathic manipulative treatment (OMT) has been demonstrated to have an effect on the autonomic nervous system, which may have antiarrhythmic effects. The effects of OMT in patients with cardiac implantable electronic devices (CIEDs) have not previously been reported. This study investigated the impact of OMT on quality of life (QOL) in this patient population. OBJECTIVES: The purpose of this study is to investigate the effects of OMT on QOL in CIED patients. METHODS: Subjects with CIEDs were recruited into a double-blind randomized controlled institutional review board (IRB)-approved clinical trial (ClinicalTrials.gov ID: NCT04004741) and randomized to OMT or light touch (control) groups. Subjects received a one-time intervention, performed by board-certified neuromusculoskeletal medicine (NMM) and osteopathic manipulative medicine (OMM) physicians. The OMT protocol utilized techniques including myofascial release, rib raising, facilitated positional release (FPR), and osteopathic cranial manipulative medicine. Subjects' QOL was assessed immediately preceding intervention and one-month postintervention utilizing the Research ANd Development (RAND) 36-Item Short Form Health Survey (SF-36, eight parameters). Groups were compared utilizing unpaired t tests; α=0.05. RESULTS: Forty-two subjects were enrolled, with four lost to follow-up, which resulted in 19 OMT and 19 control subjects for analysis. Of the eight QOL parameters, two showed significant improvement with OMT: role limitations due to physical health (p=0.001) and pain (p=0.003). CONCLUSIONS: This study demonstrates the potential for QOL improvement in CIED patients. Specifically, subjects in the OMT group reported an improvement in activities of daily living as well as a decrease in overall pain, including pain interfering with work. Additional research is necessary to further understand the physiologic effects of OMT, including its effects on arrhythmias, in CIED patients.