TTE and Dysphagia in Anterior Cervical Surgery

NCT ID: NCT02326116

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2023-12-21

Brief Summary

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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.

Detailed Description

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Conditions

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Dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group 1

Trachael Traction Exercises

Group Type EXPERIMENTAL

Trachael Preparation Education

Intervention Type OTHER

Group 2

Trachael Massage

Group Type PLACEBO_COMPARATOR

Trachael Preparation Education

Intervention Type OTHER

Interventions

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Trachael Preparation Education

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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54543

Identifier Type: -

Identifier Source: org_study_id

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