TTE and Dysphagia in Anterior Cervical Surgery

April 1, 2024 updated by: Addisu Mesfin, University of Rochester

Investigating the Role of Tracheal Traction Exercises (TTE) in Reducing Dysphagia Following Anterior Cervical Surgery

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SWAL-QOL
Time Frame: 12 months
30% difference in dysphagia as quantified by the SWAL-QOL (validated measure of dysphagia)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

December 21, 2023

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

December 20, 2014

First Submitted That Met QC Criteria

December 24, 2014

First Posted (Estimated)

December 25, 2014

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 54543

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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