TTE and Dysphagia in Anterior Cervical Surgery

• Sponsor: University of Rochester (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02326116
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Duration (Months): 96
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate if Tracheal Traction Exercises (TTE) performed prior to anterior cervical spine surgery can result in a decreased rate of dysphagia.

Condition or Disease	Intervention/Treatment	Phase
Dysphagia	Other: Trachael Preparation Education	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Investigating the Role of Tracheal Traction Exercises (TTE) in Reducing Dysphagia Following Anterior Cervical Surgery
• Study Start Date: Nov 1, 2014
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Trachael Traction Exercises	Other: Trachael Preparation Education
Placebo Comparator: Group 2 Trachael Massage	Other: Trachael Preparation Education

Outcome Measures

Primary Outcome Measures

1. SWAL-QOL [12 months]

   30% difference in dysphagia as quantified by the SWAL-QOL (validated measure of dysphagia)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Elective Anterior cervical spine surgery (C2-C7) for degenerative disc disease or myelopathy

Exclusion Criteria:

• More than four levels of fusion

• Trauma or urgent cases of anterior cervical spine surgery

• Prior anterior cervical spine surgery (a known risk factor for dysphagia),

• Prior neck surgery (eg. Thyroidectomy)

• Tumors

• Infections

• Neurological disorders that can predispose to dysphagia such as Parkinson's, Cerebrovascular Accidents (CVA), Alzheimer's and Amyotrophic Lateral Sclerosis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Addisu Mesfin, Physician, University of Rochester
• ClinicalTrials.gov Identifier: NCT02326116
• Other Study ID Numbers: 54543
• First Posted: Dec 25, 2014
• Last Update Posted: Jan 4, 2022
• Last Verified: Jan 1, 2022

• Additional relevant MeSH terms: Deglutition Disorders

Study Results

No Results Posted as of Jan 4, 2022