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

Primary Purpose

Pain, Quality of Life

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Group Phototherapy
Phototherapy + Physical activity
Physical activity
Placebo
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Phototherapy, Laser, Fibromyalgia, DTM/ TMD, Pain

Eligibility Criteria

35 Years - 58 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Mariana Moreira Da SilvaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

placebo (P)

phototherapy (FT)

phototherapy+Physical activity (FT+A)

Physical activity (A)

Arm Description

Intervention without radiation

Intervention only with phototherapy radiation

Intervention associated

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
October 14, 2014
Last Updated
December 13, 2015
Sponsor
University of Nove de Julho
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT02279225
Brief Title
Protocol Phototherapy Treatment for Fibromyalgia and Temporomandibular Joint Dysfunction
Acronym
FM and DTM
Official Title
RANDOMIZED DOUBLE-BLIND CONTROLLED THE USE OF PHOTOTHERAPY IN FIBROMIÁLGICOS WITH TEMPOROMANDIBULAR JOINT DYSFUNCTION
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Quality of Life
Keywords
Phototherapy, Laser, Fibromyalgia, DTM/ TMD, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo (P)
Arm Type
Placebo Comparator
Arm Description
Intervention without radiation
Arm Title
phototherapy (FT)
Arm Type
Experimental
Arm Description
Intervention only with phototherapy radiation
Arm Title
phototherapy+Physical activity (FT+A)
Arm Type
Experimental
Arm Description
Intervention associated
Arm Title
Physical activity (A)
Arm Type
Experimental
Arm Description
Intervention with physical activity: the gold standard of treatment in fibromyalgia
Intervention Type
Radiation
Intervention Name(s)
Group Phototherapy
Intervention Type
Radiation
Intervention Name(s)
Phototherapy + Physical activity
Intervention Type
Other
Intervention Name(s)
Physical activity
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Pain
Description
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.
Time Frame
10 sessions, in 5 weeks, 2 times a week
Secondary Outcome Measure Information:
Title
Quality of sleep
Description
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
Time Frame
before and after: 10 sessions in 5 weeks, 2 times a week
Title
Quality of life
Description
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.
Time Frame
10 sessions, in 5 weeks, 2 times a week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariana Moreira da Silva55011
Phone
55 011 992248813
Email
fisioterapeutamariana@gmail.com
Facility Information:
Facility Name
Mariana Moreira Da Silva
City
São Caetano do Sul
State/Province
SP
ZIP/Postal Code
09560500
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARIANA MOREIRA D SILVA
Phone
+5511992248813

12. IPD Sharing Statement

Citations:
PubMed Identifier
26040789
Citation
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.
Results Reference
derived

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Protocol Phototherapy Treatment for Fibromyalgia and Temporomandibular Joint Dysfunction

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