Efficacy of Therapeutic Exercise and Pain Neurophysiology Education in Temporomandibular Disorders: a Single-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
The aim of this study is to compare the effects in pain of two different treatments in pacients with temporomandibular disorders (TMD). One group will receive isolated therapeutic exercise (TE) and the other will receive TE combined with pain neurophysiology education (PNE). The hypothesis of this study is that the PNE+TE group will obtain superior therapeutic results than an isolated TE program.
详细描述
Objective
To evaluate the differences in pain intensity by performing isolated therapeutic exercise (TE) versus performing the same exercise combined with pain neurophysiology education (PNE) in patients with temporomandibular disorders (TMD).
Design: Single-blind randomized controlled trial. Setting: Faculty of Physical Therapy of Alcalá de Henares. Participants: Subjects with TMD lasting more than 6 months (N= 36). Interventions: Participants will be randomly assigned to receive a TE program consisting of stretching, coordination and strengthening exercises (n= 18) or the same TE program in addition to a PNE program (n= 18), performed in two sessions of 40 minutes in groups of 6 participants. The intervention will last 12 weeks, where all participants must complete the exercise program daily, one year later they will be evaluated again.
Main outcome measures: The primary outcome will be pain intensity through the visual analogue scale (VAS) which will be completed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment. Secondary outcome measures include pain-free mouth opening, Craniofacial Pain and Disability Inventory (CF-PDI), Pain Catastrophizing Scale (PCS), Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-11), pressure pain thresholds (PPT) and Patient Global Impression of Change (PGIC). They will be recorded through blinded assessments performed by 2 physiotherapists at baseline, immediately after treatment, 4 and 12 weeks after treatment. Student's t test will be used to determine differences between group interventions.
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age
- •Limitation of mouth opening and/or jaw pain lasting more than 6 months
- •Being able to understand the objective and carry out the study procedures
- •Sign the informed consent.
排除标准
- •Suffer from any underlying disease
- •Pain due to tumors or infections, metastases, osteoporosis, inflammatory arthritis or fractures
- •Be receiving any other treatment for TMD or consuming some type of substance that alters muscle tone.
- •Patients with myopathies, diseases of the Peripheral Nervous System, mental disorders diagnosed by a doctor
- •Inability to collaborate
- •Any other situation in which the evaluation could be altered.
结局指标
主要结局
Pain intensity
时间窗: The scale will be passed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment.
The intensity of pain will be evaluated using the Visual Analogue Scale that is represented by a 10cm line where the left end indicates "no pain" and the right end indicates "maximum pain".
次要结局
- Mouth opening without pain(at baseline, immediately after treatment, 4 and 12 weeks after treatment.)
- Orofacial disability and pain(at baseline, immediately after treatment, 4 and 12 weeks after treatment.)
- Kinesiophobia(at baseline, immediately after treatment, 4 and 12 weeks after treatment.)
- Pressure pain thresholds(at baseline, immediately after treatment, 4 and 12 weeks after treatment.)
- Catastrophism(at baseline, immediately after treatment, 4 and 12 weeks after treatment.)
- Self-Perception of Improvement(at baseline, immediately after treatment, 4 and 12 weeks after treatment.)
研究者
María Teresa Ortiz Moreno
MSc
University of Alcala