Effect of Phototherapy on Pain, Muscles Activity and Joint Mobility in Individuals With Temporomandibular Disorder: A Randomized, Placebo-Controlled and Double-Blind Clinical Trial.
试验速览
- 阶段
- 1 期
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Pain intensity.
研究概览
简要总结
The present study aims to evaluate the effect of phototherapy with the combination of different sources of light on pain, activity of temporal and masseter muscles, bilateral and joint mobility in subjects with TMD. It will be made a randomized, placebo-controlled and double-blind clinical trial. Individuals participate with myogenic temporomandibular disorder, being allocated into 4 groups randomly and stratified by the method of sealed envelopes. The results will be evaluated using: RDC/TMD, digital caliper, electromyography, and visual analog scale and algometry. The protocols will be used in a single session and will be evaluated in four different moments. The variables that will be investigated are pain, muscle activity and joint mobility. The analyses of the data will be performed by adopting a significance level of 5%.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 to 40 years.
- •Female volunteers.
- •Diagnosis of myogenic TMD pain must masseter presenting moderate to severe according to the RDC / TMD.
- •Display body mass index (BMI) less than 25 kg/m2 to standardize the sample.
- •In addition, volunteers must submit scores of pain greater than 3 cm according to the Visual Analog Scale masticatory muscles.
排除标准
- •history of neurological disorders.
- •chronic neck pain resulting from a traumatic incident.
- •chronic musculoskeletal condition.
- •medical diagnosis of fibromyalgia; systemic disease.
- •connective tissue disorder.
- •having undergone physical therapy use of analgesic, muscle relaxant.
结局指标
主要结局
Pain intensity.
时间窗: 1 year
Will be used a algometry D-200 of Instrutherm ®, which is a semi quantitative method to measure the intensity of the pain by the pressure, find painful spots, in addition to quantify changes the various pain syndromes.
次要结局
- Electromyographic activity(1 year)
研究者
Daniela Ap. Biasotto-Gonzalez
Doctor
University of Nove de Julho