Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Evaluate the effectiveness of physical therapy using the VAS scale which allows to measure the varation of pain
研究概览
简要总结
The aim of study is evaluate the effectiveness of physical therapy in of the treatment myogenic temporomandibular disorders.
They will enrolled 100 patient which will be divided into two groups. The primary objective is evaluate the effectiveness of physiotherapy on pain (measured with the Visual Analogic Scale - VAS scale).
The second objective is evaluate mandibular motion (by measuring the range of motion - ROM) and investigate the presence of psychosocial factors (using the Anxiety and Depression Scale - HADS questionnaire).
详细描述
Randomized controlled clinical trial with randomization according to a multi-phase design.
Phase 1 involves the enrollment of patients with DTMs based on diagnostic criteria.
Phase 2 includes the algogenic, kinetic and gnathological evaluation of the enrolled patients.
Phase 3 provides for the adoption of the criterion to one of the 2 treatment groups on the basis of the randomization list.
The 2 therapeutic protocols are:
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with myogenic temporomandibular disorders assessed with clinical examination as established by the DC / TMD1;
- •patients older than 18 years;
- •good knowledge of Italian language;
- •patients who have signed informed consent
排除标准
- •edentulism which makes it impossible to apply gnathological bite;
- •patients with psychiatric problems;
- •patients included in other experimental protocols;
- •patients already undergoing surgical and / or radial therapy of the cervical and facial areas;
- •other temporomandibular disorders without a myogenic component;
- •treatment of the cervical and TMJ district in the previous 3 months;
- •history of drug abuse.
结局指标
主要结局
Evaluate the effectiveness of physical therapy using the VAS scale which allows to measure the varation of pain
时间窗: Change from initial VAS at 3 and 6 months from the beginning of the treatment
The VAS measures the intensity of the pain that thethe patient perceived and it is represented by a 10 cm long scale with a score from 0 to 10. The VAS will be evaluated in 3 times: at rest; during the maximum buccal opening; during chewing
次要结局
- ROM (range of motion)(The measurement of the ROM occurs at the recruitment then at 3 and 6 months from the beginning of the treatment)
研究者
Paolo Pillastrini
professor
University of Bologna