Protocol Phototherapy Treatment for Fibromyalgia and Temporomandibular Joint Dysfunction

Not Applicable

• Conditions: Pain; Quality of Life
• Interventions: Radiation: Group Phototherapy; Other: Placebo; Radiation: Phototherapy + Physical activity; Other: Physical activity

• Registration Number: NCT02279225
• Lead Sponsor: University of Nove de Julho

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-31
• Status Verified: 2015-10
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-13
• Last Update Posted: 2015-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
phototherapy (FT)	Group Phototherapy	Intervention only with phototherapy radiation
placebo (P)	Placebo	Intervention without radiation
phototherapy+Physical activity (FT+A)	Phototherapy + Physical activity	Intervention associated
Physical activity (A)	Physical activity	Intervention with physical activity: the gold standard of treatment in fibromyalgia

Primary Outcome Measures

Name	Time	Method
Pain	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life	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.
Quality of sleep	before and after: 10 sessions in 5 weeks, 2 times a week	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

Trial Locations

Locations (1)

Mariana Moreira Da Silva; 🇧🇷 São Caetano do Sul, SP, Brazil