Maximum Interincisal Opening
Conditions
Keywords
trismus, head and neck cancer, radiotherapy, maximum interincisal opening
Brief summary
Trismus is traditionally considered being a late effect of cancer therapy with functional deficits becoming clear in the first year after completing radiation therapy. These deficits can rapidly progress to a state of functional impairment. The most common treatment for trismus is physical therapy comprising an active range of motion (ROM) exercises, hold and relax techniques. Once trismus has developed, it may be hard to reverse. Thus, prevention with a program of self-care is important for managing this side effect. This study want to test the effect with adjunctive devices plus exercise to prevent trismus.
Interventions
BEHAVIORALexercise therapy plus jaw device
The mouth-opening rehabilitation exercise lasts for twelve weeks, five days a week, three times a day. Subjects can arrange to perform before or after meals according to personal eating time and preferences. The experimental group performs 30 minutes each time, including 20 minutes of stretching exercises. Ten-minute mouth expander assisted passive exercise.
BEHAVIORALexercise therapy
the control group performed 20-minute stretching exercises each time.
Sponsors
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age is greater than or equal to 20 years old. 2. Those who are able to communicate in Mandarin and Taiwanese and have no reading or listening or writing disabilities can fill out the questionnaire by themselves or with the assistance of the researcher. 3. Diagnosed with head and neck cancer, and is expected to receive head and neck radiation therapy for the first time. 4. A clear consciousness, no severe cognitive impairment or mental symptoms. 5. Willing to participate in this research and obtain consent.
Exclusion criteria
1. People with known temporomandibular joint disorders. 2. The maximum opening degree is less than or equal to 25 mm. 3. Those who have received radiotherapy for the head and neck in the past. 4. Those who have been diagnosed by a physician for poor wound healing after surgery and unable to perform mouth-opening rehabilitation exercises.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of maximum interincisal opening (MIO) | baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months. | Using Gothenburg Trismus Questionnaire, GTQ to measure the trismus condition and mouth opening |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of fatigue level | baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months. | using the Brief Fatigue Inventory, BFI to measure fatigue level |
| Quality of life (QOL) | baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months. | using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Head and Neck 35-questions, EORTC-QLQ-C30-H&N35 to meaure QOL |
Outcome results
None listed