Protocol Phototherapy Treatment for Fibromyalgia and Temporomandibular Joint Dysfunction

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
RANDOMIZED DOUBLE-BLIND CONTROLLED THE USE OF PHOTOTHERAPY IN FIBROMIÁLGICOS WITH TEMPOROMANDIBULAR JOINT DYSFUNCTION

Conditions
-----------------
Quality of Life, Pain

Intervention / Treatment
-----------------
* Radiation: Group Phototherapy
* Radiation: Phototherapy + Physical activity
* Other: Physical activity
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 58 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo (P)<br>Intervention without radiation | Other: Placebo<br> <br> |
| Experimental: phototherapy (FT)<br>Intervention only with phototherapy radiation | Radiation: Group Phototherapy<br> <br> |
| Experimental: phototherapy+Physical activity (FT+A)<br>Intervention associated | Radiation: Phototherapy + Physical activity<br> <br> |
| Experimental: Physical activity (A)<br>Intervention with physical activity: the gold standard of treatment in fibromyalgia | Other: Physical activity<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | 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. | 10 sessions, in 5 weeks, 2 times a week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of sleep | The time corresponds to assess changes: Performs initial assessment a week before the first session and the revaluation performs after a week of the last session. evaluation with polysomnography | before and after: 10 sessions in 5 weeks, 2 times a week | 
| Quality of life | 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. | 10 sessions, in 5 weeks, 2 times a week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phototherapy, Laser, Fibromyalgia, DTM/ TMD, Pain