Comparison of Two Therapies for UES Dysphagia

描述(由申请人提供)： 咽期吞咽困难可能是中风和头颈部癌症化疗放射治疗的严重和昂贵的副作用，导致患者定期抽气，无法通过口腔进食。咽期吞咽困难的一个主要亚型是吞咽时不能完全通过上食道括约肌(UES)移动团状物。对于这种情况，现有的治疗方法是有限的，并产生了一定程度的成功，但一种新的治疗程序，振动器练习，提供了一个令人兴奋的新机会，使这些患者康复，可能比通常的治疗计划更有效和更有效率。我们提出的5年计划是对严重咽期吞咽困难患者进行这两种疗法的随机临床试验，这些患者无法将推进剂完全通过UES。患者必须至少有三个月的时间是非口腔的，因为从其中一个或两个梨状窦吸入残留物。 该项目的主要目标是确定两种治疗方案中的哪一种--Shaker运动疗法和传统疗法--能够使最多的稳定的非口腔吞咽困难患者在干预6周后能够安全地吞咽并恢复完全口腔喂养。这项研究得到了足够的支持，因此这一目标可以分别用于放化疗后治疗、头颈癌和中风患者。我们的结果衡量标准是恢复口服喂养，即100%的营养和口服补水。 我们的次要目标是：1)以描述性方式确定在吞咽后吸入残留的梨状窦残留的患者是否比吞咽后吸入梨状窦残留的患者或在两个位置有残留的患者反应更好，即他们可以恢复到100%的口服摄入量，从而定义两组研究的吞咽困难患者中所建议的运动计划的适应症范围，以及2)定义由于每个治疗计划的结果而改变的病理生理因素，包括最大吞咽UES开放的前后径和侧径的变化，以及B.最大吞咽喉前位和上位移位。

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.