Immediate Effects of the Mandibular Muscle Energy Technique in Patients With Mandibular Joint Pathology and Bruxism. Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in craniofacial pain intensity
研究概览
简要总结
This is a randomized, controlled, double-blind clinical trial. The main objective is to evaluate the immediate effect of the mandibular muscle-energy technique on pain, functionality and kinesiophobia in subjects suffering from temporomandibular dysfunction and bruxism.
In the experimental group the jaw muscle-energy technique will be applied and in the control group a placebo technique will be applied. The intention is to see the immediate effects of the intervention and two evaluations of the pre- and post-intervention outcome variables and a follow-up of kinesiophobia one week later will be performed.
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
The participants will be blinded because in both groups they were following the treatment and medical recommendations and they will also be attended by a physiotherapist, in one case the mandibular muscular energy technique will be performed and in the other the placebo technique.
The evaluators did not know to which group the participants belonged.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who agree to participate in the study by signing the informed consent form.
- •Patients attending maxillofacial consultation with pain, temporomandibular dysfunction and bruxism.
- •Pain of at least 3 months of evolution.
排除标准
- •Patients with congenital malformations or cervical spine pathology.
- •Infectious or inflammatory disease in its acute phase.
- •Patients with vertigo or vestibular alterations.
- •If there is a contraindication to the technique or phobia on the part of the patient.
- •Physiotherapy treatment (manual therapy or electrotherapy) in the last month before their incorporation in the study.
- •Pharmacological treatment (analgesics, relaxants and anti-inflammatory drugs) in the last 24 hours before the initial evaluation.
结局指标
主要结局
Changes in craniofacial pain intensity
时间窗: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
For the subjective evaluation of craniofacial pain, the visual analog scale (VAS) will be applied. Scale from 0 (no pain at all) to 10 (maximum possible pain).
次要结局
- Changes in leftward mandibular translation(2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.)
- Changes in rightward mandibular translation(2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.)
- Changes in mouth opening mobility(2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.)
- Changes in pressure pain threshold at myofascial trigger point of the both external pterygoid muscles(2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.)
- Changes in kinesiophobia(2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group. And a follow-up after one week)
- Changes in pressure pain threshold at myofascial trigger point of the both digastric muscles(2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.)
- Changes in Pressure pain threshold at myofascial trigger point (PT1) of the both upper trapezius muscles(2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.)
研究者
Roberto Méndez Sánchez
Professor, PhD
University of Salamanca