Dynasplint Therapy for Trismus in Head and Neck Cancer (HNO 0602)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dynasplint Therapy for Trismus in Head and Neck Cancer|
- Assess effectiveness of DTS on improved ability to open the mouth [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Assess degree of long term improvement of ability to open the mouth after discontinuation of the use of DTS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Assess the rate of improvement of ability to open the mouth while using DTS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Patients randomized to Arm 1 will be treated for 6 months with the Dynasplint System
Device: Dynasplint Trismus System
The Dynasplint System will be used for 6 months.
Active Comparator: 2
Patients randomized to Arm 2 will use tongue blades for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint System
Other: Tongue Blades
Tongue Blades to be used for 3 months at which time mouth opening will be measured. If there is no change then the patient will crossover to the Dynasplint System for another 3 months.
|United States, Alabama|
|UAB Division of Otolaryngology|
|Birmingham, Alabama, United States, 35233|
|Principal Investigator:||William Carroll, MD||University of Alabama at Birmingham|