Comparison of Two Therapies for Upper Esophageal Sphincter (UES) Dysphagia

Comparison of Two Therapies for UES Dysphagia

The aim of this research study is to determine the effectiveness of: 1) a traditional therapy regimen focusing on individual exercises for pharyngeal (throat) and laryngeal (voice box) musculature and 2) a new therapeutic exercise, the Shaker exercise.

The primary objective of this 5-year 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 head and neck cancer and stroke patients. Our primary outcome measure is return to oral feeding, i.e., 100% of nutrition and hydration by mouth.

Study Overview

• Status: Completed
• Conditions: Deglutition Disorders
• Intervention / Treatment: Procedure: Shaker Exercise vs. Traditional Dysphagia Therapy Regime

Detailed Description

Secondary aims of this research are:

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% oral intake, than patients with residue in the valleculae who aspirate after the swallow 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 groups of dysphagic patients (stroke and post-chemo radiation treatment for head and neck cancer) and whether postures enable each patient type to swallow more bolus types without aspiration at pre- and post

2. Define the pathophysiology underlying the swallow dysfunction and those pathophysiologic elements which change as a result of each therapy program including changes in -

   1. anteroposterior and lateral diameter of maximum deglutitive UES opening
   2. maximum deglutitive laryngeal anterior and superior excursions

• Study Type: Interventional
• Enrollment: 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States
      • Medical College University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria (all required)

• Patients with pharyngeal phase dysphagia due to stroke or chemoradiation for head and neck cancer (without surgical intervention)
• Incomplete UES opening and post-deglutitive aspiration
• Hypopharyngeal (pyriform sinus) residue or vallecular residue alone or in combination
• Dysphagia requiring tube feeding (at least 3 months non-oral condition)
• Able to comply with protocol mandates, willing to perform the exercise programs, and ability to attend study sessions.

Exclusion Criteria

• Pharyngeal surgical procedures
• Other neuromuscular disorders such as
• Lack of cognition
• Metabolic myopathies
• History of alcoholic neuropathy
• Steroid myopathy
• Cervical spine injury, lesions, or large osteophytes
• Kerns-Sayers Syndrome
• Individuals unable to exercise independently
• Oculo-pharyngeal and other dystrophies
• Current use of anticholinergics:

bensodiazopin, antihistamines

• Myasthenia gravis
• Elimination of aspiration with posture during VFG
• Absent pharyngeal swallow on VFG
• Aspiration before or during the swallow (pre and intradeglutitive aspiration)
• Not completely tube feeding dependent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED

Collaborators and Investigators

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Reza Shaker, M.D., Professor and Chief, Division of Gastroenterology and Hepatology, Director, Digestive Disease Center, Medical College of Wisconsin; Principal Investigator: Jerilyn A. Logemann, Ph.D., Professor Department of Communication Sciences and Disorders, Ralph and Jean Sundin Professor of Communication Sciences and Disorders, Northwestern University

Publications and helpful links

General Publications

• Shaker R, Easterling C, Kern M, Nitschke T, Massey B, Daniels S, Grande B, Kazandjian M, Dikeman K. Rehabilitation of swallowing by exercise in tube-fed patients with pharyngeal dysphagia secondary to abnormal UES opening. Gastroenterology. 2002 May;122(5):1314-21. doi: 10.1053/gast.2002.32999.

Helpful Links

• Division of Gastroenterology and Hepatology

Study record dates

Study Major Dates

• Study Completion (ACTUAL): December 1, 2007

Study Registration Dates

• First Submitted: May 1, 2003
• First Submitted That Met QC Criteria: May 1, 2003
• First Posted (ESTIMATE): May 2, 2003

Study Record Updates

• Last Update Posted (ESTIMATE): January 13, 2010
• Last Update Submitted That Met QC Criteria: January 12, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Dysphagia; UES
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: UESD (completed)