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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02326116
Other study ID # 54543
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 2014
Est. completion date June 30, 2024

Study information

Verified date April 2024
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 150
Est. completion date June 30, 2024
Est. primary completion date December 21, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Trachael Preparation Education


Locations

Country Name City State
United States University of Rochester Rochester New York

Sponsors (1)

Lead Sponsor Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary SWAL-QOL 30% difference in dysphagia as quantified by the SWAL-QOL (validated measure of dysphagia) 12 months
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