- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02326116
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
- Name: Addisu Mesfin, MD
- Phone Number: 585-275-5196
- Email: addisu_mesfin@urmc.rochester.edu
Study Contact Backup
- Name: Ashley Owens, CCRC
- Phone Number: 585-341-9303
- Email: Ashley_Owens@URMC.Rochester.edu
Study Locations
-
-
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
|
|
Placebo Comparator: Group 2
Trachael Massage
|
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
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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