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. To evaluate and compare the rehabilitative effectiveness of the sequential 4-channel NMES with that of conventional 2-channel NMES. 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. 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. 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 .

中文翻译：

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一项前瞻性双盲随机对照研究中序贯 4 通道 NMES 与常规 2 通道 NMES 治疗吞咽困难的临床疗效比较

迄今为止，常规吞咽疗法和 2 通道神经肌肉电刺激 (NMES) 是吞咽困难的标准治疗方法。2通道NMES治疗的确切机制尚未确定，对该疗法的疗效存在争议。最近开发了连续 4 通道 NMES，其作用基于吞咽相关肌肉的正常收缩序列。评估和比较顺序 4 通道 NMES 与传统 2 通道 NMES 的康复效果。在这项前瞻性随机病例对照研究中，招募了 26 名吞咽困难的受试者。所有参与者都接受了 2-3 周的 2 或 4 通道 NMES（最小会话：7 次，治疗持续时间：300-800 分钟）。4 通道 NMES 组的 12 名受试者和 2 通道 NMES 组的 11 名受试者完成了干预。使用荧光透视吞咽困难量表 (VDS)、穿刺-吸入量表 (PAS)、MD Anderson 吞咽困难量表 (MDADI)、功能性口服摄入量表 (FOIS) 和李克特量表进行初始和后续评估。根据治疗前的数据，顺序 4 通道 NMES 组的 VDS（口腔、咽部和总分）、PAS、FOIS 和 MDADI（情绪、功能和身体子集）评分有显着改善。VDS（口腔、咽部和总分）和 MDADI（情绪和身体子集）评分，但不是 PAS 和 FOIS 评分，在 2 通道 NMES 组治疗后显着改善。当直接比较两组时，4 通道 NMES 组在口腔和总 VDS 评分方面显示出显着改善。顺序 4 通道 NMES，通过激活舌骨上肌和甲状舌骨肌，以及其他模仿生理激活的舌骨下肌，可能是治疗吞咽困难的一种新的有效方法。试验注册：clinicaltrial.gov，注册号：NCT03670498，2018年9月13日注册，https://clinicaltrials.gov/ct2/show/NCT03670498?term=NCT03670498&draw=2&rank=1。