Rochester, New York 14642


Purpose:

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.


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.


Study is Available At:


Original ID:

54543


NCT ID:

NCT02326116


Secondary ID:


Study Acronym:


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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Rochester


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

120


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Addisu Mesfin, MD
585-275-5196
addisu_mesfin@urmc.rochester.edu
Backup Contact:Emily L Cosimano, RN CCRC
585-341-9056
Emily_Cosimano@urmc.rochester.edu

Study Dates

Start Date:November 2014
Completion Date:November 2021
Completion Type:Anticipated
Primary Completion Date:November 2020
Primary Completion Type:Anticipated
Verification Date:December 2019
Last Changed Date:December 5, 2019
First Received Date:December 20, 2014

Study Outcomes

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

Study Interventions

Intervention Type:Other
Name:Trachael Preparation Education
Arm Name:Group 1

Study Arms

Study Arm Type:Experimental
Arm Name:Group 1
Description:Trachael Traction Exercises
Study Arm Type:Placebo Comparator
Arm Name:Group 2
Description:Trachael Massage

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Rochester

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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