Kyoung-Ho Seo1, Joonyoung Jang2, Eun Gyeong Jang2, Yulhyun Park2, So Young Lee3, Bo Ryun Kim4, Donghwi Park5, Sungwon Park6, Hyeoncheol Hwang7, Nam Hun Kim7, Byung-Mo Oh8, Han Gil Seo8, Jun Chang Lee2, Ju Seok Ryu9. 1. Department of Rehabilitation Medicine, Seongnam Citizen's Medical Center, Seongnam-si, South Korea. 2. Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, 82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea. 3. Department of Rehabilitation Medicine, Jeju National University Hospital, Jeju National University College of Medicine, Jeju-do, South Korea. 4. Department of Physical Medicine and Rehabilitation, Korea University Anam Hospital, Seoul, South Korea. 5. Department of Physical Medicine and Rehabilitation, Ulsan University Hospital, Ulsan University College of Medicine, Ulsan, South Korea. 6. Department of Rehabilitation Medicine, Daegu Fatima Hospital, Daegu, South Korea. 7. Department of Rehabilitation Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong-Si, South Korea. 8. Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea. 9. Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, 82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea. jseok337@snu.ac.kr.
Abstract
BACKGROUND: To date, conventional swallowing therapies and 2-channel neuromuscular electrical stimulation (NMES) are standard treatments for dysphagia. The precise mechanism of 2-channel NMES treatment has not been determined, and there are controversies regarding the efficacy of this therapy. The sequential 4-channel NMES was recently developed and its action is based on the normal contractile sequence of swallowing-related muscles. OBJECTIVE: To evaluate and compare the rehabilitative effectiveness of the sequential 4-channel NMES with that of conventional 2-channel NMES. METHODS: In this prospective randomized case-control study, 26 subjects with dysphagia were enrolled. All participants received 2- or 4-channel NMES for 2-3 weeks (minimal session: 7 times, treatment duration: 300-800 min). Twelve subjects in the 4-channel NMES group and eleven subjects in the2-channel NMES group completed the intervention. Initial and follow-up evaluations were performed using the videofluoroscopic dysphagia scale (VDS), the penetration-aspiration scale (PAS), the MD Anderson dysphagia inventory (MDADI), the functional oral intake scale (FOIS), and the Likert scale. RESULTS: The sequential 4-channel NMES group experienced significant improvement in their VDS (oral, pharyngeal, and total), PAS, FOIS, and MDADI (emotional, functional, and physical subsets) scores, based on their pretreatment data. VDS (oral, pharyngeal, and total) and MDADI (emotional and physical subsets) scores, but not PAS and FOIS scores, significantly improved in the 2-channel NMES group posttreatment. When the two groups were directly compared, the 4-channel NMES group showed significant improvement in oral and total VDS scores. CONCLUSIONS: The sequential 4-channel NMES, through its activation of the suprahyoid and thyrohyoid muscles, and other infrahyoid muscles mimicking physiological activation, may be a new effective treatment for dysphagia. TRIAL REGISTRATION: clinicaltrial.gov, registration number: NCT03670498, registered 13 September 2018, https://clinicaltrials.gov/ct2/show/NCT03670498?term=NCT03670498&draw=2&rank=1 .
RCT Entities:
BACKGROUND: To date, conventional swallowing therapies and 2-channel neuromuscular electrical stimulation (NMES) are standard treatments for dysphagia. The precise mechanism of 2-channel NMES treatment has not been determined, and there are controversies regarding the efficacy of this therapy. The sequential 4-channel NMES was recently developed and its action is based on the normal contractile sequence of swallowing-related muscles. OBJECTIVE: To evaluate and compare the rehabilitative effectiveness of the sequential 4-channel NMES with that of conventional 2-channel NMES. METHODS: In this prospective randomized case-control study, 26 subjects with dysphagia were enrolled. All participants received 2- or 4-channel NMES for 2-3 weeks (minimal session: 7 times, treatment duration: 300-800 min). Twelve subjects in the 4-channel NMES group and eleven subjects in the 2-channel NMES group completed the intervention. Initial and follow-up evaluations were performed using the videofluoroscopic dysphagia scale (VDS), the penetration-aspiration scale (PAS), the MD Anderson dysphagia inventory (MDADI), the functional oral intake scale (FOIS), and the Likert scale. RESULTS: The sequential 4-channel NMES group experienced significant improvement in their VDS (oral, pharyngeal, and total), PAS, FOIS, and MDADI (emotional, functional, and physical subsets) scores, based on their pretreatment data. VDS (oral, pharyngeal, and total) and MDADI (emotional and physical subsets) scores, but not PAS and FOIS scores, significantly improved in the 2-channel NMES group posttreatment. When the two groups were directly compared, the 4-channel NMES group showed significant improvement in oral and total VDS scores. CONCLUSIONS: The sequential 4-channel NMES, through its activation of the suprahyoid and thyrohyoid muscles, and other infrahyoid muscles mimicking physiological activation, may be a new effective treatment for dysphagia. TRIAL REGISTRATION: clinicaltrial.gov, registration number: NCT03670498, registered 13 September 2018, https://clinicaltrials.gov/ct2/show/NCT03670498?term=NCT03670498&draw=2&rank=1 .