<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03017339</url>
  </required_header>
  <id_info>
    <org_study_id>1.442.759</org_study_id>
    <nct_id>NCT03017339</nct_id>
  </id_info>
  <brief_title>Effect of a Functional Exercise Program Associated With Low Level Laser Therapy on Fibromyalgia</brief_title>
  <official_title>Effect of a Functional Exercise Program Associated With Low Level Laser Therapy on Pain, Functional Capacity and Quality of Life in Individuals With Fibromyalgia: A Double-blind Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Rio Grande do Norte</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Rio Grande do Norte</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effects of a functional exercise program&#xD;
      associated with Low Level Laser Therapy (LLLT) on pain, functional capacity and quality of&#xD;
      life of individuals with fibromyalgia. Half of participants will receive functional exercise&#xD;
      and LLLT, while the other half will receive functional exercise and placebo LLLT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain assessed by Visual Analogue Scale</measure>
    <time_frame>Pain assessment two months after the intervention</time_frame>
    <description>Assessed by Visual Analogue Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain assessed by Widespread Pain Index</measure>
    <time_frame>Pain assessment two months after the intervention</time_frame>
    <description>Assessed by Widespread Pain Index</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Laser Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects participated in a functional exercise program associated with low level laser therapy applied in the quadriceps, hamstrings and triceps sural</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The subjects participated in a functional exercise program associated with placebo low level laser therapy applied in the quadriceps, hamstrings and triceps sural</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Functional Exercise</intervention_name>
    <arm_group_label>Laser Group</arm_group_label>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Low Level Laser Therapy</intervention_name>
    <arm_group_label>Laser Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Placebo Low Level Laser Therapy</intervention_name>
    <description>Low Level Laser Therapy with the device off</description>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being female;&#xD;
&#xD;
          -  age between 30 and 50 years;&#xD;
&#xD;
          -  have an ovulatory cycle;&#xD;
&#xD;
          -  height between 1.50m and 1.80m, body mass between 50 and 80 kg and BMI in the range of&#xD;
             18.5 to 29.9 kg / m2;&#xD;
&#xD;
          -  present a clinical diagnosis of fibromyalgia, signed by a rheumatologist according to&#xD;
             the current criteria of the American College of Rheumatology;&#xD;
&#xD;
          -  is at least 6 months without any physical exercise;&#xD;
&#xD;
          -  do not present musculoskeletal conditions that prevent them from performing the&#xD;
             evaluation and proposed physical activity, except FM;&#xD;
&#xD;
          -  not having diabetes mellitus and uncontrolled blood pressure;&#xD;
&#xD;
          -  they do not present an inflammatory rheumatic condition or serious cardiovascular and&#xD;
             / or pulmonary disease that prevents them from performing the evaluation and the&#xD;
             proposed physical activity;&#xD;
&#xD;
          -  Not having psychiatric illness or having malignant tumors;&#xD;
&#xD;
          -  is not pregnant&#xD;
&#xD;
          -  did not present dengue, zika or chikungunya in the last year;&#xD;
&#xD;
          -  and finally not to be hypersensitive to light.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not attend for more than two consecutive exercise sessions&#xD;
&#xD;
          -  at any time and for any reason expressing an intention to leave the study&#xD;
&#xD;
          -  present a health problem that prevents them from continuing to carry out the proposed&#xD;
             exercises&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Federal University of Rio Grande do Norte</name>
      <address>
        <city>Natal</city>
        <state>RN</state>
        <zip>59072-970</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Rio Grande do Norte</investigator_affiliation>
    <investigator_full_name>Wouber Hérickson de Brito Vieira</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Low Lever Laser Therapy</keyword>
  <keyword>Exercise Therapy</keyword>
  <keyword>Chronic Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03017339
org study id: 1.442.759
nct id: NCT03017339
lead sponsor: 
has dmc: Yes
The purpose of this study is to investigate the effects of a functional exercise program
      associated with Low Level Laser Therapy (LLLT) on pain, functional capacity and quality of
      life of individuals with fibromyalgia. Half of participants will receive functional exercise
      and LLLT, while the other half will receive functional exercise and placebo LLLT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Pain assessed by Visual Analogue Scale
time frame: Pain assessment two months after the intervention
description: Assessed by Visual Analogue Scale
measure: Pain assessed by Widespread Pain Index
time frame: Pain assessment two months after the intervention
description: Assessed by Widespread Pain Index
arm group label: Laser Group
arm group type: Experimental
description: The subjects participated in a functional exercise program associated with low level laser therapy applied in the quadriceps, hamstrings and triceps sural
arm group label: Placebo Group
arm group type: Placebo Comparator
description: The subjects participated in a functional exercise program associated with placebo low level laser therapy applied in the quadriceps, hamstrings and triceps sural
intervention type: Other
intervention name: Functional Exercise
arm group label: Laser Group
arm group label: Placebo Group
intervention type: Radiation
intervention name: Low Level Laser Therapy
arm group label: Laser Group
intervention type: Radiation
intervention name: Placebo Low Level Laser Therapy
description: Low Level Laser Therapy with the device off
arm group label: Placebo Group
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Rio Grande do Norte
investigator full name: Wouber Hérickson de Brito Vieira
investigator title: PhD
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes