<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/NCT02210520</url>
  </required_header>
  <id_info>
    <org_study_id>São Lucas College</org_study_id>
    <nct_id>NCT02210520</nct_id>
  </id_info>
  <brief_title>Effect of Ultrasound and Laser in Chronic Low Back Pain: Randomized Double-blinded Controled Trial</brief_title>
  <official_title>Effect of Laser and Ultrasound in Pain and Disability in Women With Chronic Non-specific Low Back Pain: Randomized Double-blinded Controled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The low level laser therapy has a better effect in decrease the pain than ultrasound&#xD;
      therapeutic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The laser will be applied with the dosimetry 3 J/cm², 2 minutes in 6 points around the back&#xD;
      spine, during 4 weeks. Before the women will be evaluate again.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2013</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Phase 1</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 (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>4 weeks</time_frame>
    <description>Visual Analog Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain quality</measure>
    <time_frame>4 weeks</time_frame>
    <description>McGill questionaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>4 Weeks</time_frame>
    <description>Roland Morris Questionaire</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">22</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 J/cm², 2 minutes in 6 points around the back spine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pulsatile ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 W/cm², 2 minutes in 6 points around the back spine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>continuous ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>pulsatile ultrasound</intervention_name>
    <description>1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.</description>
    <arm_group_label>continuous ultrasound</arm_group_label>
    <arm_group_label>laser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>continuous ultrasound</intervention_name>
    <description>1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.</description>
    <arm_group_label>laser</arm_group_label>
    <arm_group_label>pulsatile ultrasound</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>laser</intervention_name>
    <description>1 W/cm², 2 minutes in 6 points around the back spine</description>
    <arm_group_label>continuous ultrasound</arm_group_label>
    <arm_group_label>pulsatile ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic low back pain&#xD;
&#xD;
          -  3,0 - 7,0 in the visual analogic scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no use of medications&#xD;
&#xD;
          -  no other treatment&#xD;
&#xD;
          -  without fractures, pregnancy, psychiatric or neurologic disorders, diabetes,&#xD;
             amputations&#xD;
&#xD;
          -  with diagnostic of low back pain&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ana Paula A Rubira, master</last_name>
    <role>Principal Investigator</role>
    <affiliation>São Paulo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>São Lucas College</name>
      <address>
        <city>Porto Velho</city>
        <state>Rondõnia</state>
        <zip>76800000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ana Paula A Rubira, Master</last_name>
      <phone>55 069 3211-8082</phone>
      <email>anapaularubira@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Ana Paula A Rubira, master</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 4, 2014</last_update_submitted>
  <last_update_submitted_qc>August 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo General Hospital</investigator_affiliation>
    <investigator_full_name>Ana Paula Fernandes A. Rubira</investigator_full_name>
    <investigator_title>Master</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</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/NCT02210520
org study id: São Lucas College
nct id: NCT02210520
lead sponsor: 
has dmc: Yes
The low level laser therapy has a better effect in decrease the pain than ultrasound
      therapeutic.
The laser will be applied with the dosimetry 3 J/cm², 2 minutes in 6 points around the back
      spine, during 4 weeks. Before the women will be evaluate again.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Pain intensity
time frame: 4 weeks
description: Visual Analog Scale
measure: Pain quality
time frame: 4 weeks
description: McGill questionaire
measure: Disability
time frame: 4 Weeks
description: Roland Morris Questionaire
arm group label: laser
arm group type: Experimental
description: 3 J/cm², 2 minutes in 6 points around the back spine
arm group label: pulsatile ultrasound
arm group type: Experimental
description: 1 W/cm², 2 minutes in 6 points around the back spine
arm group label: continuous ultrasound
arm group type: Experimental
description: 1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.
arm group label: control
arm group type: No Intervention
description: no treatment.
intervention type: Device
intervention name: pulsatile ultrasound
description: 1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.
arm group label: continuous ultrasound
arm group label: laser
intervention type: Device
intervention name: continuous ultrasound
description: 1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.
arm group label: laser
arm group label: pulsatile ultrasound
intervention type: Device
intervention name: laser
description: 1 W/cm², 2 minutes in 6 points around the back spine
arm group label: continuous ultrasound
arm group label: pulsatile ultrasound
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Ana Paula A Rubira, master
role: Principal Investigator
affiliation: São Paulo University
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo General Hospital
investigator full name: Ana Paula Fernandes A. Rubira
investigator title: Master
mesh term: Back Pain
mesh term: Low Back Pain