Effects of Manual Therapy on Oral Opening, Swallow Function, and Upper Quarter Mobility in Chilean Survivors of Head and Neck Cancer: A Study Protocol for a Controlled, Randomized Study (MATEO Study, MAnual ThErapy for Oral Opening).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Maximal mouth opening (MMO)
研究概览
简要总结
Trismus has been reported as the second most common comorbidity in survivors of head and neck cancer (HNC). It is mainly associated with post-radiotherapy subcutaneous fibrosis, muscular atrophy, damage to neurological structures in the neck, or a combination of all, affecting masticatory musculature. In addition to this, the loss of flexibility and strength in the shoulder has also been shown to be related to deficits in the function and quality of life of these patients.
The goal of this clinical trial is to determinate the effectiveness and safety of Manual Therapy (MT) on Oral Opening, Swallow Function, as well as the mobility of the upper quarter, the strength of cervical musculature, pain, functionality, and the perception of quality of life in head and neck cancer survivors.
Participants will be assigned randomly to the study groups: a) manual therapy program and control motor exercises and b) motor control exercises (usual care).
The assessment refers to a baseline form (at the beginning of the study), at 6 weeks and at 6 weeks of patient follow-up.
详细描述
Manual therapy program consists of 3 sessions a week during 6 weeks, with a total of 18 appointments. Measurements are done before starting, after the last intervention and 6 weeks after finishing the treatment.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •individuals with HNC
- •individuals over 18 years of age
- •individuals who have undergone oncological surgery of the head and neck and/or radiotherapy
- •having finished oncological medical treatment between 3 and 36 months before inclusion
- •having a medical diagnosis of trismus and/or TMD and/or cervical or shoulder dysfunction
- •Spanish native speakers
排除标准
- •sequelae of previous stroke
- •structural instability and/or osteoporosis of the cervical spine, spondylosis, cervical herniated discs
- •active osteoradionecrosis or open wounds (fistulas, soft tissue necrosis) in the anatomical treatment area
- •tracheostomized individuals
- •metastasis or active cancer
- •refuse to participate.
结局指标
主要结局
Maximal mouth opening (MMO)
时间窗: 6 weeks
MMO will be assessed with a sliding calliper measuring the inter-incisor distance asking the patients to open the mouth as maximum as possible.
Temporomandibular disorders (TMD)
时间窗: 6 weeks
TMD will be assessed with the Fonseca Anamneses Index, that classifies TMD as no dysfunction, light dysfunction, moderate dysfunction or severe dysfunction
Swallowing function
时间窗: 6 weeks
Eating Assessment Tool (EAT-10) will be used to evaluate self-reported swallowing impairments. It is a 5 point Likert scale rating from no impairment to severe problem. The sum of all items contained on the questionnaire is used as the overall score, suggesting an abnormal swallowing when score is higher than 3
Swallowing difficulty
时间窗: 6 weeks
A Visual Analogue Scale (VAS) will be used to register swallowing difficulties, ranging from 0 (no problems) to 10 (impossible to swallow)
Dysphagia
时间窗: 6 weeks
Water Swallow Test, subject will be ask to drink 100 mL of water as quickly as is comfortably possible. The time to swallow this 100 mL (in seconds) and the number of swallows will be count.
次要结局
- Satisfaction with the treatment(6 weeks)
- Shoulder active range of motion (AROM)(6 weeks)
- Deep cervical flexors endurance(6 weeks)
- Isometric handgrip strength(6 weeks)
- Cervical active range of motion (AROM)(6 weeks)
- Adverse Events (AE)(6 weeks)
- Muscle Function Test(6 weeks)
- Health-related quality of life(6 weeks)
- Pain Intensity(6 weeks)
- Physical Fitness(6 weeks)
- Pressure pain thresholds(6 weeks)
- Shoulder pain and disability perception(6 weeks)
- Health-related quality of life 2(6 weeks)
研究者
Barbara Burgos Mansilla
PhD
Universidad de La Frontera