RANDOMIZED DOUBLE-BLIND CONTROLLED THE USE OF PHOTOTHERAPY IN FIBROMIÁLGICOS WITH TEMPOROMANDIBULAR JOINT DYSFUNCTION
试验速览
- 阶段
- 不适用
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
Temporomandibular joint dysfunction is described as a multifactorial disease and can be directly linked to other diseases, being of structural factors of the Stomatognathic System or not, such as fibromyalgia. Studies show the interconnection of Temporomandibular Dysfunctions with fibromyalgia. Thus, this project aims to evaluate the effect of Phototherapy on fibromiálgicos patients with temporomandibular dysfunction This is a Randomized, Controlled and double-blind, with the intention to treat. In this way the sample of 61 patients with Fibromyalgia, Temporomandibular joint Dysfunction associated with ages between 35 to 58 years, females who are selected after the inclusion/exclusion criteria, will be randomly distributed in homogeneous groups and the placebo group (P), Phototherapy (FT) group, group of physical activity (A) aerobic and aerobic physical activity + Phototherapy Group (FT + A). Will be used as a means of analysis before and after interventions the following parameters: Pain: clinical evaluation, evaluation of pain by Visual analog scale of pain (EVA), McGill Pain Questionnarire and pressure Algometria. Still we will evaluate the dosage of serotonin, indirectly, by saliva. Quality of life: own illness as questionnaires FIQ (Fibromyalgia Impact Questionnaire), Medical Outcomes Study 36-item Short-Form Health Survey SF-36 and also will assess the quality of sleep, with polysomnography. The treatments will total in 10 sessions held twice a week, and the FT and FT + groups to receive Phototherapy enforcement will be used a portable cluster 9 diodes, where will be delivered 39.3 Joules in tender points of fibromyalgia and TMJ, groups and FT + to carry out aerobic activity in 75% of your MHR for 50 min and the P group will receive the application of Phototherapy of 0 Joules (IE, the equipment does not emit any power). Statistical analysis will be compared using the t test intra-group-Student, one-tail and paired and can be used the Kruskal-Wallis test, the statistical analysis of significance 0.05 for both tests.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 58 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Fibromyalgia according to the criteria of the American College of Rheumatology;
- •Clinical diagnosis of TMD by the RDC questionnaire (annex I);
- •Cognitive Level enough to understand the procedures and follow the guidelines that will be passed;
- •People who use drugs corresponding to Fibromyalgia (FM), antidepressant;
- •Class I of angle
- •Consent to participate in the study and sign the consent form post information.
排除标准
- •With psychiatric disorders;
- •Cognitive Changes;
- •People who perform some exercise;
- •People who carry out orthodontic treatment;
- •Systemic diseases;
- •Persons under the age of 35 and more than 58 years.
结局指标
主要结局
Pain
时间窗: 10 sessions, in 5 weeks, 2 times a week
The time corresponds to assess changes: Assessed on the first day before the start of the first session and the reassessment is made after the last session, after half an hour of intervention. Assessed with questionnaires, and EVA, and algometry.
次要结局
- Quality of life(10 sessions, in 5 weeks, 2 times a week)
- Quality of sleep(before and after: 10 sessions in 5 weeks, 2 times a week)
研究者
Mariana Moreira da Silva
RANDOMIZED DOUBLE-BLIND CONTROLLED THE USE OF PHOTOTHERAPY IN FIBROMIÁLGICOS WITH TEMPOROMANDIBULAR JOINT DYSFUNCTION
University of Nove de Julho