<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/NCT03801941</url>
  </required_header>
  <id_info>
    <org_study_id>2016_67</org_study_id>
    <secondary_id>2018-A01729-46</secondary_id>
    <nct_id>NCT03801941</nct_id>
  </id_info>
  <brief_title>Alleviating Trunk Low Back Pain, With an Active Medical Device Study (ATLAS)</brief_title>
  <acronym>ATLAS</acronym>
  <official_title>Cross Over Pilot Study for Evaluation of Pain Reduction in Patients With Chronic Low Back Pain (for More Than 3 Month) Using an Innovative Handheld Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>JAPET MEDICAL DEVICE</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate the reduction of pain by wearing the ATLAS Medical Device&#xD;
      in standardized daily activities for patients with Chronic Low Back Pain.&#xD;
&#xD;
      This is an intervention al non blinded study with a crossover design comparing pain evaluated&#xD;
      with an Analogue Visual Scale with and without the ATLAS device during 5 standardized daily&#xD;
      activities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims at assessing pain release by wearing a new medical device (ATLAS) in patients&#xD;
      affected by chronic low back pain.&#xD;
&#xD;
      Population: patients with chronic low back pain admitted for a 4 weeks rehabilitation&#xD;
      program.&#xD;
&#xD;
      Intervention: active rehabilitation and wearing the ATLAS device 60 min per day. The ATLAS&#xD;
      study is carried out during the 5 first days of the rehabilitation program.&#xD;
&#xD;
      Primary outcome: Pain intensity evaluation with a 100 mm Visual Analogue Scale (VAS) during 5&#xD;
      standardized activities (the most intensive pain during the 5 activities is recorded), with&#xD;
      and without wearing the ATLAS device.&#xD;
&#xD;
      Secondary outcome measures: percentage of patients reporting pain decrease of at least 20 mm&#xD;
      on the 100 mm VAS during the 5 standardized activities with the ATLAs device compared without&#xD;
      wearing the device. Percentage of relieved patients (percentage of patient reporting pain&#xD;
      intensity less than 30 mm on the 100 mm VAS with wearing the device). Pain intensity&#xD;
      evaluated with the 100 mm VAS before and after 60 min of wearing the ATLAS device.&#xD;
&#xD;
      Randomization: two groups (i.e. group A and B). Primary outcome is evaluated at day 4 and 5,&#xD;
      with a crossover design (Group A: pain is evaluated during activities with the device at day&#xD;
      4 and without the device at day 5. Group B: pain is evaluated during activities without the&#xD;
      device at day 4 and with the device at day 5).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain release with the ATLAS device during standardized daily activities</measure>
    <time_frame>at 5th day of a 4 weeks rehabilitation program.</time_frame>
    <description>Pain intensity evaluation with a 100 mm Visual Analogue Scale (VAS) from 0 to 100 mm (0 means no pain and 100 means extremely severe pain) during the standardized daily activities (the most intense pain reported during the 5 activities is recorded).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain release with the ATLAS device during standardized daily activities</measure>
    <time_frame>at day the 1st , 4th day of a 4 weeks rehabilitation program.</time_frame>
    <description>Pain intensity evaluation with a 100 mm Visual Analogue Scale (VAS) from 0 to</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of improved patients</measure>
    <time_frame>at day the 1st , 4th and 5th day of a 4 weeks rehabilitation program.</time_frame>
    <description>Percentage of patients reporting pain improvement of at least 20 mm on the Visual Analogue Scale with the ATLAS device during the 5 standardized daily activities compared to the pain reported without wearing the ATLAS device during the same 5 standardized daily activities (the most intense pain reported during the 5 activities is recorded).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients relieved with the ATLAS device</measure>
    <time_frame>at day the 1st , 4th and 5th day of a 4 weeks rehabilitation program.</time_frame>
    <description>Percentage of patients wearing the ATLAS device reporting pain intensity less than 30 mm on a 100mm Visual Analogue scale during the 5 standardized daily activities (the most intense pain reported during the 5 activities is recorded).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Wearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities with the ATLAS Device at the 4th day and without the device at the 5th day of a 4 weeks rehabilitation program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Wearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities without the ATLAS Device at the 4th day and with the device at the 5th day of a 4 weeks rehabilitation program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>wearing ATLAS device during evaluation at 4th day</intervention_name>
    <description>Wearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities with or without ATLAS Device at the 4th or 5th day of a 4 weeks rehabilitation program.</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>wearing ATLAS device during evaluation at 5th day</intervention_name>
    <description>Wearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities without ATLAS Device at the 4th or 5th day of a 4 weeks rehabilitation program.</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic low back pain for more than 3 month&#xD;
&#xD;
          -  Analogical visual scale superior or egal to 3/10&#xD;
&#xD;
          -  BMI &lt; 30&#xD;
&#xD;
          -  18 &lt; Age &lt; 75 years&#xD;
&#xD;
          -  Patients who signed the informed consent&#xD;
&#xD;
          -  Hospital Anxiety and depression score less than 11&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Neurological or radicular deficit&#xD;
&#xD;
          -  Skin pathology of the trunk region&#xD;
&#xD;
          -  Antecedent of surgery of spinal fusion&#xD;
&#xD;
          -  Implanted neurostimulation treatment&#xD;
&#xD;
          -  Scoliosis with Cobb angle &gt; 30°&#xD;
&#xD;
          -  History of vertebral fracture&#xD;
&#xD;
          -  BMI &gt; 30&#xD;
&#xD;
          -  Respiratory failure&#xD;
&#xD;
          -  Recent rib fracture (less than 3 month)&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Osteoporosis&#xD;
&#xD;
          -  Refusal to participate to the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vincent Tiffreau, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Swynghedau, CHU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>February 28, 2022</last_update_submitted>
  <last_update_submitted_qc>February 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Low back pain</keyword>
  <keyword>Medical device</keyword>
  <keyword>Spine</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Traction</keyword>
  <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/NCT03801941
org study id: 2016_67
secondary id: 2018-A01729-46
nct id: NCT03801941
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to evaluate the reduction of pain by wearing the ATLAS Medical Device
      in standardized daily activities for patients with Chronic Low Back Pain.

      This is an intervention al non blinded study with a crossover design comparing pain evaluated
      with an Analogue Visual Scale with and without the ATLAS device during 5 standardized daily
      activities.
This study aims at assessing pain release by wearing a new medical device (ATLAS) in patients
      affected by chronic low back pain.

      Population: patients with chronic low back pain admitted for a 4 weeks rehabilitation
      program.

      Intervention: active rehabilitation and wearing the ATLAS device 60 min per day. The ATLAS
      study is carried out during the 5 first days of the rehabilitation program.

      Primary outcome: Pain intensity evaluation with a 100 mm Visual Analogue Scale (VAS) during 5
      standardized activities (the most intensive pain during the 5 activities is recorded), with
      and without wearing the ATLAS device.

      Secondary outcome measures: percentage of patients reporting pain decrease of at least 20 mm
      on the 100 mm VAS during the 5 standardized activities with the ATLAs device compared without
      wearing the device. Percentage of relieved patients (percentage of patient reporting pain
      intensity less than 30 mm on the 100 mm VAS with wearing the device). Pain intensity
      evaluated with the 100 mm VAS before and after 60 min of wearing the ATLAS device.

      Randomization: two groups (i.e. group A and B). Primary outcome is evaluated at day 4 and 5,
      with a crossover design (Group A: pain is evaluated during activities with the device at day
      4 and without the device at day 5. Group B: pain is evaluated during activities without the
      device at day 4 and with the device at day 5).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Pain release with the ATLAS device during standardized daily activities
time frame: at 5th day of a 4 weeks rehabilitation program.
description: Pain intensity evaluation with a 100 mm Visual Analogue Scale (VAS) from 0 to 100 mm (0 means no pain and 100 means extremely severe pain) during the standardized daily activities (the most intense pain reported during the 5 activities is recorded).
measure: Pain release with the ATLAS device during standardized daily activities
time frame: at day the 1st , 4th day of a 4 weeks rehabilitation program.
description: Pain intensity evaluation with a 100 mm Visual Analogue Scale (VAS) from 0 to
measure: Percentage of improved patients
time frame: at day the 1st , 4th and 5th day of a 4 weeks rehabilitation program.
description: Percentage of patients reporting pain improvement of at least 20 mm on the Visual Analogue Scale with the ATLAS device during the 5 standardized daily activities compared to the pain reported without wearing the ATLAS device during the same 5 standardized daily activities (the most intense pain reported during the 5 activities is recorded).
measure: Percentage of patients relieved with the ATLAS device
time frame: at day the 1st , 4th and 5th day of a 4 weeks rehabilitation program.
description: Percentage of patients wearing the ATLAS device reporting pain intensity less than 30 mm on a 100mm Visual Analogue scale during the 5 standardized daily activities (the most intense pain reported during the 5 activities is recorded).
arm group label: Group A
arm group type: Experimental
description: Wearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities with the ATLAS Device at the 4th day and without the device at the 5th day of a 4 weeks rehabilitation program.
arm group label: Group B
arm group type: Experimental
description: Wearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities without the ATLAS Device at the 4th day and with the device at the 5th day of a 4 weeks rehabilitation program.
intervention type: Device
intervention name: wearing ATLAS device during evaluation at 4th day
description: Wearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities with or without ATLAS Device at the 4th or 5th day of a 4 weeks rehabilitation program.
arm group label: Group A
arm group label: Group B
intervention type: Other
intervention name: wearing ATLAS device during evaluation at 5th day
description: Wearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities without ATLAS Device at the 4th or 5th day of a 4 weeks rehabilitation program.
arm group label: Group A
arm group label: Group B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Vincent Tiffreau, MD,PhD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain