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Feasibility Study of Dynasplint to Prevent Trismus in Head and Neck Cancer

NCT01649583 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-04-04

No results posted yet for this study

Summary

The purpose of this study is to see if use of a device called the Jaw Dynasplint® System can be used during and immediately after cancer treatment. The Dynasplint® is a stretching device that is used to treat joint stiffness and limited range of motion in the jaw. The device is currently approved for treatment of trismus once it has developed. This study will investigate the use of the device during and immediately after cancer treatment to prevent trismus.

Conditions

Interventions

DEVICE

Jaw Dynasplint System

Patients on the intervention arm will wear the Jaw Dynasplint® System for 30 minutes, 3 times per day each day during the cancer treatment period and for the first 3 months after primary or adjuvant based-radiation treatment (recovery period) is completed. Patients will maintain a daily patient log indicating the amount of time they used the Jaw Dynasplint® System.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Lauren A Zatarain, MD · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01649583 on ClinicalTrials.gov