The Effectiveness of the Pressure Release Technique on Masticatory and Neck Muscle Trigger Points in Patients With Chronic Myofascial Temporomandibular Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Changes of Perceived Pain Between Three Time Points (Baseline, Post-treatment, and 3 Months Later) and Between Groups (Sham Simulation and Pressure Release Technique)
研究概览
简要总结
Participants with chronic orofacial pain caused by masticatory and neck muscles will be distributed in two groups, both followed with the same occlusal and self-care treatment. The experimental group will receive 5 sessions of physiotherapy applying a specific pressure on the trigger points while the control group will receive placebo through a simulation of the same technique. Orofacial perceived pain, pain pressure thresholds, catastrophizing, kinesiophobia, cervical disability, depression and anxiety will be evaluated at baseline, immediately after treatment and 3 months later.
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, Outcomes Assessor)
盲法说明
Participants don´t know to which group are assigned The statistical assessor don´t know the aim of the study
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
- •Patients ≥18 years.
- •Patients diagnosed of myofascial TMD with at least one TrP with referred pain.
- •TMD patients with a current complaint of myofascial pain with more than 6 months of evolution.
- •Patients with myofascial TMD initially treated with splint currently used, that has not been modified in the last 6 months, without improvement.
排除标准
- •Patients treated with occlusal splint recently modified.
- •Patients with acute TMJ diseases.
- •Patients with systemic disease, neurological and muscular diseases.
- •Patients with psychiatric or psychological disorders.
- •Patients with cervical disc hernia and acute whiplash injury.
- •Changes in the painkillers intake during the experiment.
结局指标
主要结局
Changes of Perceived Pain Between Three Time Points (Baseline, Post-treatment, and 3 Months Later) and Between Groups (Sham Simulation and Pressure Release Technique)
时间窗: Change from baseline in the scale at post-treatment and at 3 months later
The Visual Analogue Scale (0-10) was used, 0 representing no pain/better outcome, and 10 representing unbearable pain/worst outcome. the clinical minimum relevance outcome is at least a change of 1.2 points in the scale.
次要结局
- Changes in the Neck Disability(Change from baseline in the scale at post-treatment and at 3 months later)
- Changes of Pain Pressure Thresholds Sternal Sternocleidomastoid(Change from baseline in the scale at post-treatment and at 3 months later)
- Changes in the Kinesiophobia(Change from baseline in the scale at post-treatment and at 3 months later)
- Changes in the Trait Anxiety(Change from baseline in the scale at post-treatment and at 3 months later)
- Changes in the Range of the Opening of the Mouth(Change from baseline in the scale at post-treatment and at 3 months later)
- Changes in the Catastrophizing(Change from baseline in the scale at post-treatment and at 3 months later)
- Changes in the State Anxiety(Change from baseline in the scale at post-treatment and at 3 months later)
- Changes of Pain Pressure Thresholds Superficial Masseter(Change from baseline in the scale at post-treatment and at 3 months later)
- Changes of Pain Pressure Thresholds Anterior Temporalis(Change from baseline in the scale at post-treatment and at 3 months later)
- Changes in the State Depression(Change from baseline in the scale at post-treatment and at 3 months later)
- Changes in the Trait Depression(Change from baseline in the scale at post-treatment and at 3 months later)
- Changes of Pain Pressure Thresholds Upper Trapezius(Change from baseline in the scale at post-treatment and at 3 months later)
研究者
Gema Serrano-Hernanz
Principal Investigator, Clinical Professor
Universidad Complutense de Madrid