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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exercise therapy plus jaw device | Experimental | exercise therapy plus jaw device |
|
| exercise therapy | Placebo Comparator | exercise therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise therapy plus jaw device | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The change of maximum interincisal opening (MIO) | Using Gothenburg Trismus Questionnaire, GTQ to measure the trismus condition and mouth opening | baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| The change of fatigue level | using the Brief Fatigue Inventory, BFI to measure fatigue level | baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months. |
| Quality of life (QOL) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D014313 | Trismus |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D013035 | Spasm |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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|
| exercise therapy | Behavioral | the control group performed 20-minute stretching exercises each time. |
|
| baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |