Comparison of Two Therapies for UES Dysphagia

UES 吞咽困难两种疗法的比较

• 批准号: 6649337
• 负责人: REZA NONE SHAKER
• 金额: $ 50.38万
• 依托单位: MEDICAL COLLEGE OF WISCONSIN
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2007-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6649337
• 关键词: cinefluorography; clinical research; clinical trial phase I; dysphagia; eating; esophagogastric junction; functional ability; head /neck neoplasm; head movements; human subject; human therapy evaluation; larynx muscle; lateral olfactory area; musculoskeletal disorder therapy; neoplasm /cancer radiation therapy; oral pharyngeal disorder; patient oriented research; physical therapy; questionnaires; rehabilitation; stroke; stroke therapy; swallowing; tongue

DESCRIPTION (provided by applicant): Pharyngeal phase dysphagia can be a severe and costly side effect of stroke and chemoradiation therapy for head and neck cancer, causing the patient to regularly aspirate and be unable to eat by mouth. A major subset of pharyngeal phase dysphagia is caused by inability to move the bolus completely through the upper esophageal sphincter (UES) during swallowing. Available therapy for this condition is limited and yields a degree of success, but a new therapy procedure, the Shaker exercise, offers an exciting new opportunity to rehabilitate these patients perhaps more effectively and efficiently than the usual therapy program. The 5 year project we are proposing is a randomized clinical trial of these two therapies in patients with severe pharyngeal phase dysphagia with inability to move the bolus completely through the UES. The patients must be non-oral for at least three months because of aspiration of residue from either or both the valleculae and pyriform sinuses. The primary objective of this project is to identify which of two therapy programs, the Shaker exercise versus traditional therapy, results in the largest number of stable, non-oral dysphagic patients who can swallow safely and return to full oral feeding after 6 weeks of intervention. The study is powered adequately so that this aim can be tested separately for post chemoradiation therapy, head and neck cancer, and stroke patients. Our outcome measure is return to oral feeding, i.e., 100-percent of nutrition and hydration by mouth. Our secondary objectives are to: 1) determine in a descriptive manner whether patients with residue in the pyriform sinuses who aspirate the residue after the swallow respond better, i.e., a higher percentage of them can return to 100-percent oral intake, than patients with residue in the valleculae or patients with residue in both locations who aspirate after the swallow and thus to define the spectrum of indications for the proposed exercise programs in the two studied groups of dysphagic patients, and 2) define the pathophysiological elements which change as a result of each therapy program including changes in a. anteroposterior and lateral diameter of maximum deglutitive UES opening, and b. maximum deglutitive laryngeal anterior and superior excursions.

描述（由申请人提供）： 咽相吞咽困难可能是中风和化学放射治疗对头颈癌的严重且昂贵的副作用，导致患者定期抽吸并且无法通过口腔进食。咽相吞咽困难的主要子集是由于无法在吞咽过程中完全通过食管上括约肌（UES）移动推注所引起的。对于这种情况，可用的疗法是有限的，并获得了一定程度的成功，但是一种新的疗法程序，即振动锻炼，为这些患者的康复提供了令人兴奋的新机会，可能比通常的治疗计划更有效，更有效。我们提出的5年项目是对严重咽相吞咽困难的患者的这两种疗法的随机临床试验，无法完全通过UES移动推注。由于从任何一个或两侧的鼻窦吸入残留物，因此患者必须至少三个月。 该项目的主要目的是确定哪种治疗计划中的哪些疗法与传统疗法相比，导致稳定的非鼻鼻涕患者数量最多，他们可以安全地吞咽并在干预6周后返回全口腔喂养。这项研究充分供电，以便可以分别测试化学放射治疗，头颈癌和中风患者的目标。我们的结果度量是恢复口服喂养，即营养和水分的100％。 Our secondary objectives are to: 1) determine in a descriptive manner whether patients with residue in the pyriform sinuses who aspirate the residue after the swallow respond better, i.e., a higher percentage of them can return to 100-percent oral intake, than patients with residue in the valleculae or patients with residue in both locations who aspirate after the swallow and thus to define the spectrum of indications for the proposed exercise programs in the two studied groups of吞咽困难患者和2）定义了由于每个疗法计划的变化，包括a的变化。最大退化UES开口的前后直径和侧直径，b。最大喉前和优质延伸。