Protocol Phototherapy Treatment for Fibromyalgia and Temporomandibular Joint Dysfunction

NCT02279225 | Unknown

• 1 other identifier: y4tma2ef
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Quality of Life

Keywords

Phototherapy; Laser; Fibromyalgia; DTM/ TMD; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Quality of sleep

  before and after: 10 sessions in 5 weeks, 2 times a week

• Quality of life

  10 sessions, in 5 weeks, 2 times a week

Study Arms (4)

placebo (P)

PLACEBO COMPARATOR

Intervention without radiation

Other: Placebo

phototherapy (FT)

EXPERIMENTAL

Intervention only with phototherapy radiation

Radiation: Group Phototherapy

phototherapy+Physical activity (FT+A)

EXPERIMENTAL

Intervention associated

Radiation: Phototherapy + Physical activity

Physical activity (A)

EXPERIMENTAL

Intervention with physical activity: the gold standard of treatment in fibromyalgia

Other: Physical activity

Interventions

Group Phototherapy RADIATION

phototherapy (FT)

Phototherapy + Physical activity RADIATION

phototherapy+Physical activity (FT+A)

Physical activity OTHER

Physical activity (A)

Placebo OTHER

placebo (P)

Eligibility Criteria

• Age: 35 Years - 58 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Mariana Moreira Da Silva

São Caetano do Sul, São Paulo, 09560500, Brazil

RECRUITING

Related Publications (1)

• da Silva MM, Albertini R, Leal-Junior EC, de Tarso Camillo de Carvalho P, Silva JA Jr, Bussadori SK, de Oliveira LV, Casarin CA, Andrade EL, Bocalini DS, Serra AJ. Effects of exercise training and photobiomodulation therapy (EXTRAPHOTO) on pain in women with fibromyalgia and temporomandibular disorder: study protocol for a randomized controlled trial. Trials. 2015 Jun 4;16:252. doi: 10.1186/s13063-015-0765-3.

  PMID: 26040789 DERIVED

MeSH Terms

Conditions

Pain; Fibromyalgia

Interventions

Phototherapy; Exercise

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Mariana Moreira da Silva55011

CONTACT

55 011 992248813; fisioterapeutamariana@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RANDOMIZED DOUBLE-BLIND CONTROLLED THE USE OF PHOTOTHERAPY IN FIBROMIÁLGICOS WITH TEMPOROMANDIBULAR JOINT DYSFUNCTION

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 31, 2014
• Study Start: March 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 15, 2015

Record last verified: 2015-10

Locations

BR (1)