Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in pain intensity
研究概览
简要总结
The aim of this randomized controlled trial is to evaluate the effects of intraoral manual therapy versus extraoral manual therapy and compare them with a control group, in the management of patients with temporomandibular disorders regarding pain, strength, quality of life, disability and anxiety.
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
- Single (Outcomes Assessor)
盲法说明
Researchers involved in recording outcome measures will not be aware of treatment allocation. Patients will be encouraged to not tell the evaluators about the received treatment.
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
- •Unilateral temporomandibular pain for more than one month.
- •Older than eighteen.
- •No previous treatment to temporomandibular pain in the last 3 months.
- •Diagnosed based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
排除标准
- •Patients with cervical or cranial trauma or whiplash.
- •Diagnosed with systemic disease, like rheumatoid arthritis or fibromyalgia.
- •Diagnosed of any vascular or metabolic disease.
- •Previous cervical or temporomandibular surgery.
- •Dental, medicine or any physical therapy treatment in the last 3 months before the beginning of the interventions.
结局指标
主要结局
Change in pain intensity
时间窗: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.
Pain intensity measured with numerical pain rating scale which ranges from 0 points (no pain) to 10 points (worst imaginable pain)
次要结局
- Change in pain pressure threshold(Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.)
- Change in range of movement of the temporomandibular joint(Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.)
- Change in quality of life(Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.)
- Change in disability(Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.)
- Change in anxiety(Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.)
研究者
Jorge Ballesteros Frutos
Principal Investigator
University of Alcala