3C-CUIDATE: Efectividad de un Programa de Recuperación Física en el Tratamiento de Las Secuelas Musculoesqueléticas, Funcionales y de Calidad de Vida en Pacientes de Cáncer de Cabeza y Cuello.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Health-related quality of life
研究概览
简要总结
People receiving a head and neck cancer treatment often do not find an adequate therapeutic response for the side effects derived from this treatment. The objective of this study is to assess the effectiveness of a physical recovery program based on manual therapy over these problems.
Previous studies have shown the effectiveness of this type of programs on patients who have had cancer in other locations with clinically relevant results. There is a shortage of proposals for this subgroup of patients that require special attention. This project intends to carry out an experimental randomized controlled study with 84 patients treated of head and neck cancer who will be assigned randomly to the study groups: a) manual therapy program or, b) control group. The assessment refers to a baseline form (at the beginning of the study), at 6 weeks and at 6 months 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 months 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To have ended their treatment in the previous 6-24 months
- •To have no metastasis or active cancer
- •To have cervical and/or temporomandibular joint pain >3 in a Visual Analogue Scale
排除标准
- •Mental or physical illness preventing subjects from participating in the study
- •Previous chronic pain conditions
- •Previous cervical or temporomandibular joint pain
- •Previous dysphagia disorders
结局指标
主要结局
Health-related quality of life
时间窗: 6 weeks
Questionnaire EORTC QLQ-C30 was used for measuring quality of life
Pain Intensity
时间窗: 6 weeks
Visual Analogue Scale was used for evaluating pain intensity at cervical, temporomandibular joint, face and shoulder levels bilaterally. This consisted of a 10 cm horizontal line with the words "no pain" at the left extreme (0) and "pain as bad as it could be" at the right extreme (10)
Health-related quality of life - 2
时间窗: 6 weeks
Questionnaire EORTC QLQ-H\&N-35 was used for measuring quality of life specifically in survivors of head and neck cancer
Pressure pain thresholds
时间窗: 6 weeks
Pressure algometry (Force Dial DFK 20 analogue algometer, Wagner, Greenwich, USA) was assessed over the temporalis, masseter, upper trapezius and levator scapulae muscles and the C5-C6 zygapophyseal joint, the sternoclavicular joint and the tibialis anterior muscle as a distant reference muscle.
Shoulder and cervical active range of motion
时间窗: 6 weeks
Shoulder active range of motion (AROM) was assessed with a two-arms goniometer joined by a 360º protractor with the patient lying on a supine position. Cervical AROM was measured in a upright sitting position with a range of motion instrument (Performance Attainment Associates, Spine Products)
次要结局
- Deep cervical flexors endurance(6 weeks)
- Maximal mouth opening(6 weeks)
- Perceived fatigue(6 weeks)
- Sleep quality(6 weeks)
- Sleeping disorders(6 weeks)
- Anxiety(6 weeks)
- Physical Fitness(6 weeks)
- Temporomandibular disorders(6 weeks)
- Shoulder pain and disability perception(6 weeks)
- Isometric handgrip strength(6 weeks)
- Fatigue(6 weeks)
- Swallowing function(6 weeks)
- Swallowing difficulty(6 weeks)
研究者
Carolina Fernández Lao
Dr. Carolina Fernández-Lao
Universidad de Granada