Spots Global Cancer Trial Database for Dynasplint Therapy for Trismus in Head and Neck Cancer
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Trial Identification
Brief Title: Dynasplint Therapy for Trismus in Head and Neck Cancer
Official Title: Dynasplint Therapy for Trismus in Head and Neck Cancer
Study ID: NCT00507208
Conditions
Study Description
Brief Summary: The purpose of this study is to compare the use of the Dynasplint Trismus System to routine trismus treatment in improving the ability of opening the mouth in a randomized trial. This study will also determine what effects, good and/or bad, this procedure has on the participant. Participants will be randomly assigned to the Dynasplint Trismus System or to routine treatment with tongue depressors.
Detailed Description: This trial is a single-institution, randomized study to evaluate the effectiveness of the Dynasplint Trismus System (DTS) for patients with trismus. Improvement of mouth opening and quality of life of participants using DTS will be compared to improvement of mouth opening and quality of life of participants using standard therapy. Standard therapy will be the use of tongue depressors. Crossover from standard therapy to DTS will be implemented if at three months there is no improvement in mouth opening when using tongue depressors.
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UAB Department of Otolaryngology, Birmingham, Alabama, United States
Contact Details
Name: William Carroll, MD
Affiliation: University of Alabama at Birmingham
Role: PRINCIPAL_INVESTIGATOR
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