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Protocol Phototherapy Treatment for Fibromyalgia and Temporomandibular Joint Dysfunction

NCT ID: NCT02279225

Last Updated: 2015-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Pain Quality of Life

Keywords

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Phototherapy Laser Fibromyalgia DTM/ TMD Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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placebo (P)

Intervention without radiation

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

phototherapy (FT)

Intervention only with phototherapy radiation

Group Type EXPERIMENTAL

Group Phototherapy

Intervention Type RADIATION

phototherapy+Physical activity (FT+A)

Intervention associated

Group Type EXPERIMENTAL

Phototherapy + Physical activity

Intervention Type RADIATION

Physical activity (A)

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

Group Type EXPERIMENTAL

Physical activity

Intervention Type OTHER

Interventions

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Group Phototherapy

Intervention Type RADIATION

Phototherapy + Physical activity

Intervention Type RADIATION

Physical activity

Intervention Type OTHER

Placebo

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

58 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

University of Nove de Julho

OTHER

Sponsor Role lead

Responsible Party

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Mariana Moreira da Silva

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mariana Moreira Da Silva

São Caetano do Sul, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Mariana Moreira da Silva55011

Role: CONTACT

Phone: 55 011 992248813

Email: [email protected]

Facility Contacts

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MARIANA MOREIRA D SILVA

Role: primary

References

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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.

Reference Type DERIVED
PMID: 26040789 (View on PubMed)

Other Identifiers

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y4tma2ef

Identifier Type: -

Identifier Source: org_study_id