A Randomized Feasibility Trial to Test Exercise Therapy Plus Jaw Device to Prevent Trismus in Patients With Head and Neck Cancer Receiving Radiation-Based Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 主要终点
- The change of maximum interincisal opening (MIO)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age is greater than or equal to 20 years old.
- •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.
- •Diagnosed with head and neck cancer, and is expected to receive head and neck radiation therapy for the first time.
- •A clear consciousness, no severe cognitive impairment or mental symptoms.
- •Willing to participate in this research and obtain consent.
排除标准
- •People with known temporomandibular joint disorders.
- •The maximum opening degree is less than or equal to 25 mm.
- •Those who have received radiotherapy for the head and neck in the past.
- •Those who have been diagnosed by a physician for poor wound healing after surgery and unable to perform mouth-opening rehabilitation exercises.
结局指标
主要结局
The change of maximum interincisal opening (MIO)
时间窗: 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
次要结局
- The change of fatigue level(baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months.)
- Quality of life (QOL)(baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months.)
研究者
Tsai-Wei Huang
Principal Investigator, Clinical Professor
Taipei Medical University