NCT02326116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 25, 2014

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2023

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

9.1 years

First QC Date

December 20, 2014

Last Update Submit

April 2, 2025

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

  • SWAL-QOL

    30% difference in dysphagia as quantified by the SWAL-QOL (validated measure of dysphagia)

    12 months

Study Arms (2)

Group 1

EXPERIMENTAL

Trachael Traction Exercises

Other: Trachael Preparation Education

Group 2

PLACEBO COMPARATOR

Trachael Massage

Other: Trachael Preparation Education

Interventions

Trachael Preparation EducationOTHER
Group 1Group 2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective Anterior cervical spine surgery (C2-C7) for degenerative disc disease or myelopathy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2014

First Posted

December 25, 2014

Study Start

November 1, 2014

Primary Completion

December 21, 2023

Study Completion

December 21, 2023

Last Updated

April 4, 2025

Record last verified: 2025-04

Locations

US(1)