Exercise Therapy Combined with a Jaw-Mobilizing Device for Improving Maximal Mouth Opening and Trismus in Patients with Head and Neck Cancer: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Maximal Mouth Opening
研究概览
简要总结
This study evaluates the effects of exercise therapy combined with a jaw-mobilizing device on enhancing quality of life in head and neck cancer patients undergoing radiotherapy.
详细描述
This study investigates the efficacy of exercise therapy combined with a jaw-mobilizing device (ET-JMD) in improving maximal mouth opening (MMO), preventing trismus, enhancing quality of life (QoL), and alleviating trismus-related symptoms in head and neck cancer (HNC) patients undergoing radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Participants are unaware of their group allocation (experimental or control) to minimize bias in self-reported outcomes and adherence to the intervention. However, investigators and outcome assessors are not masked due to the nature of the intervention.
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 ≥ 20 years.
- •Ability to communicate in Mandarin or Taiwanese, without significant reading, hearing, or writing impairments, and capable of completing questionnaires independently or with researcher assistance.
- •Diagnosed with head and neck cancer and scheduled for initial radiotherapy to the head and neck region.
- •Clear consciousness without severe cognitive or psychiatric disorders.
- •Presence of intact central incisors (#11, #41) on the right side or (#21, #31) on the left side of both the upper and lower jaws.
- •Baseline maximal mouth opening (MMO) ≥ 25 mm.
- •Willingness to participate in the study with signed informed consent.
排除标准
- •Known temporomandibular joint disorders.
- •Postoperative wound healing complications diagnosed by a physician that prevent participation in mouth-opening rehabilitation exercises.
研究组 & 干预措施
Experimental Group
Participants in the experimental group will receive a combination of exercise therapy and a jaw-mobilizing device. The intervention includes structured exercise therapy sessions and the use of the jaw-mobilizing device for 12 weeks, beginning one week prior to radiotherapy. Follow-ups will occur at weeks 16, 24, and 36 to assess outcomes.
干预措施: combination of exercise therapy and a jaw-mobilizing device (Behavioral)
Control Group
Participants in the control group will receive exercise therapy only. This intervention involves the same structured exercise therapy sessions as the experimental group for 12 weeks, beginning one week prior to radiotherapy. Follow-ups will occur at weeks 16, 24, and 36 to assess outcomes.
干预措施: exercise therapy only (Behavioral)
结局指标
主要结局
Maximal Mouth Opening
时间窗: Baseline to Week 36
Change in Maximal Mouth Opening (MMO) from Baseline to Week 36. higher score means worse.
次要结局
- Quality of Life Scores(Baseline to Week 36)
- Trismus-Related Symptom Distress Scores(Baseline to Week 36)
研究者
Tsai-Wei Huang
Professor
Taipei Medical University