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Protocol Phototherapy Treatment for Fibromyalgia and Temporomandibular Joint Dysfunction (FM and DTM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02279225
Recruitment Status : Unknown
Verified October 2015 by Mariana Moreira da Silva, University of Nove de Julho.
Recruitment status was:  Recruiting
First Posted : October 31, 2014
Last Update Posted : December 15, 2015
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Mariana Moreira da Silva, 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.

Condition or disease Intervention/treatment Phase
Pain Quality of Life Radiation: Group Phototherapy Radiation: Phototherapy + Physical activity Other: Physical activity Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: RANDOMIZED DOUBLE-BLIND CONTROLLED THE USE OF PHOTOTHERAPY IN FIBROMIÁLGICOS WITH TEMPOROMANDIBULAR JOINT DYSFUNCTION
Study Start Date : March 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Pain [ Time Frame: 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 :
  1. Quality of sleep [ Time Frame: 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

  2. Quality of life [ Time Frame: 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.



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Ages Eligible for Study:   35 Years to 58 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279225


Contacts
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Contact: Mariana Moreira da Silva55011 55 011 992248813 fisioterapeutamariana@gmail.com

Locations
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Brazil
Mariana Moreira Da Silva Recruiting
São Caetano do Sul, SP, Brazil, 09560500
Contact: MARIANA MOREIRA D SILVA    +5511992248813      
Sponsors and Collaborators
University of Nove de Julho
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mariana Moreira da Silva, RANDOMIZED DOUBLE-BLIND CONTROLLED THE USE OF PHOTOTHERAPY IN FIBROMIÁLGICOS WITH TEMPOROMANDIBULAR JOINT DYSFUNCTION, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02279225    
Other Study ID Numbers: y4tma2ef
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: October 2015
Keywords provided by Mariana Moreira da Silva, University of Nove de Julho:
Phototherapy
Laser
Fibromyalgia
DTM/ TMD
Pain
Additional relevant MeSH terms:
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Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Muscular Diseases
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes