TTE and Dysphagia in Anterior Cervical Surgery

Overview

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.

Full Title of Study: “Investigating the Role of Tracheal Traction Exercises (TTE) in Reducing Dysphagia Following Anterior Cervical Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Investigator)
  • Study Primary Completion Date: December 31, 2023

Interventions

  • Other: Trachael Preparation Education

Arms, Groups and Cohorts

  • Experimental: Group 1
    • Trachael Traction Exercises
  • Placebo Comparator: Group 2
    • Trachael Massage

Clinical Trial Outcome Measures

Primary Measures

  • SWAL-QOL
    • Time Frame: 12 months
    • 30% difference in dysphagia as quantified by the SWAL-QOL (validated measure of dysphagia)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Rochester
  • Provider of Information About this Clinical Study
    • Principal Investigator: Addisu Mesfin, Physician – University of Rochester

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