Back to resultsTTE and Dysphagia in Anterior Cervical Surgery
Primary Purpose
Dysphagia
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trachael Preparation Education
Sponsored by
About this trial
This is an interventional prevention trial for Dysphagia
Eligibility Criteria
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.
Sites / Locations
- University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group 1
Group 2
Arm Description
Trachael Traction Exercises
Trachael Massage
Outcomes
Primary Outcome Measures
SWAL-QOL
30% difference in dysphagia as quantified by the SWAL-QOL (validated measure of dysphagia)
Secondary Outcome Measures
Full Information
NCT ID
NCT02326116
First Posted
December 20, 2014
Last Updated
August 29, 2023
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT02326116
Brief Title
TTE and Dysphagia in Anterior Cervical Surgery
Official Title
Investigating the Role of Tracheal Traction Exercises (TTE) in Reducing Dysphagia Following Anterior Cervical Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Trachael Traction Exercises
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Trachael Massage
Intervention Type
Other
Intervention Name(s)
Trachael Preparation Education
Primary Outcome Measure Information:
Title
SWAL-QOL
Description
30% difference in dysphagia as quantified by the SWAL-QOL (validated measure of dysphagia)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
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TTE and Dysphagia in Anterior Cervical Surgery
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