<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/NCT03755817</url>
  </required_header>
  <id_info>
    <org_study_id>2017015F</org_study_id>
    <nct_id>NCT03755817</nct_id>
  </id_info>
  <brief_title>Efficacy Assessment of SCENAR Device on Common Spinal Pain Syndrome</brief_title>
  <acronym>SCENAR1</acronym>
  <official_title>Immediate Efficacy Assessment of SCENAR's Session on a Common Spinal Pain Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized, singled blinded, controlled trial of the efficacy of a SCENAR session in patients&#xD;
      with vertebral pain. SCENAR is an electrotherapy device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2018</start_date>
  <completion_date type="Actual">November 21, 2020</completion_date>
  <primary_completion_date type="Actual">November 21, 2020</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy on resting pain at the end of SCENAR application: NRS</measure>
    <time_frame>30 minutes</time_frame>
    <description>Self-assessment of pain using the pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 (&quot;no pain&quot;) to 10 (&quot;worst possible pain&quot;)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy on pain at mobilization the end of SCENAR application: NRS</measure>
    <time_frame>30 minutes</time_frame>
    <description>Self-assessment of pain intensity using the pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 (&quot;no pain&quot;) to 10 (&quot;worst possible pain&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy on anxiety the end of SCENAR application: NRS</measure>
    <time_frame>30 minutes</time_frame>
    <description>Self-assessment of anxiety using the pain numeric rating scale (NRS), on which patients rate their current anxiety from 0 (&quot;no anxiety&quot;) to 10 (&quot;worst possible anxiety&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy on the sensation of spinal blockage at the end of SCENAR application: NRS</measure>
    <time_frame>30 minutes</time_frame>
    <description>Self-assessment of the sensation of spinal blockage using the numeric rating scale (NRS), on which patients rate their current blockage from 0 (&quot;complete blockage&quot;) to 10 (&quot;perfect mobility&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy on resting pain on the following day: NRS</measure>
    <time_frame>1 day</time_frame>
    <description>Self-assessment of pain using the pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 (&quot;no pain&quot;) to 10 (&quot;worst possible pain&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy on pain at mobilization on the following day: NRS</measure>
    <time_frame>1 day</time_frame>
    <description>Self-assessment of pain using the pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 (&quot;no pain&quot;) to 10 (&quot;worst possible pain&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy on the sensation of spinal blockage on the following day: NRS</measure>
    <time_frame>1 day</time_frame>
    <description>Self-assessment of the sensation of spinal blockage using the numeric rating scale (NRS), on which patients rate their current anxiety from 0 (&quot;complete blockage&quot;) to 10 (&quot;perfect mobility&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy on anxiety on the following day: NRS</measure>
    <time_frame>1 day</time_frame>
    <description>Self-assessment of anxiety using the numeric rating scale (NRS), on which patients rate their current anxiety from 0 (&quot;no anxiety&quot;) to 10 (&quot;worst possible anxiety&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Collection of possible side effects</measure>
    <time_frame>1 day</time_frame>
    <description>Open question</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>Scenar application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Application of SCENAR device on</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Scenar application with the device off</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Application of SCENAR device off</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SCENAR application</intervention_name>
    <description>Active SCENAR application on the painful area</description>
    <arm_group_label>Scenar application</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SCENAR application with the device off</intervention_name>
    <description>Placebo SCENAR application on the painful area</description>
    <arm_group_label>Scenar application with the device off</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female over 18 and under 80 years of age&#xD;
&#xD;
          -  Suffering of common spinal pain: cervical pain including cervico-brachial neuralgia,&#xD;
             lumbar pain including lumbo-radiculalgia&#xD;
&#xD;
          -  Having attended a &quot;pain consultation&quot; or referred to a pain consultant during&#xD;
             hospitalization&#xD;
&#xD;
          -  Having signed the consent form&#xD;
&#xD;
          -  Can be contacted directly by phone if patient is not hospitalized&#xD;
&#xD;
          -  Be affiliated to a national insurance scheme or benefiting from such a program&#xD;
&#xD;
        Non-inclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Patients with a pacemaker&#xD;
&#xD;
          -  Patients whose skin condition makes the use of SCENAR impossible (wounds, recent&#xD;
             scars, skin infections)&#xD;
&#xD;
          -  Patient whose spinal pain is known to be related to inflammatory pathology&#xD;
             (spondylarthropathy, rheumatoid arthritis, chondrocalcinosis), trauma (fractures and&#xD;
             dislocations), tumor (metastases, myeloma localization), spondylodiscitis infectious,&#xD;
             neurological (intrarachidian tumor or posterior fossa) or radiculalgia with deficient&#xD;
             signs&#xD;
&#xD;
          -  Patients who have already had a SCENAR session&#xD;
&#xD;
          -  Patients who have already participated in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc Fischler, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hopital Foch</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>January 7, 2021</last_update_submitted>
  <last_update_submitted_qc>January 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spinal pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Somatoform Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03755817
org study id: 2017015F
nct id: NCT03755817
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Randomized, singled blinded, controlled trial of the efficacy of a SCENAR session in patients
      with vertebral pain. SCENAR is an electrotherapy device.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Efficacy on resting pain at the end of SCENAR application: NRS
time frame: 30 minutes
description: Self-assessment of pain using the pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain")
measure: Efficacy on pain at mobilization the end of SCENAR application: NRS
time frame: 30 minutes
description: Self-assessment of pain intensity using the pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain")
measure: Efficacy on anxiety the end of SCENAR application: NRS
time frame: 30 minutes
description: Self-assessment of anxiety using the pain numeric rating scale (NRS), on which patients rate their current anxiety from 0 ("no anxiety") to 10 ("worst possible anxiety")
measure: Efficacy on the sensation of spinal blockage at the end of SCENAR application: NRS
time frame: 30 minutes
description: Self-assessment of the sensation of spinal blockage using the numeric rating scale (NRS), on which patients rate their current blockage from 0 ("complete blockage") to 10 ("perfect mobility")
measure: Efficacy on resting pain on the following day: NRS
time frame: 1 day
description: Self-assessment of pain using the pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain")
measure: Efficacy on pain at mobilization on the following day: NRS
time frame: 1 day
description: Self-assessment of pain using the pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain")
measure: Efficacy on the sensation of spinal blockage on the following day: NRS
time frame: 1 day
description: Self-assessment of the sensation of spinal blockage using the numeric rating scale (NRS), on which patients rate their current anxiety from 0 ("complete blockage") to 10 ("perfect mobility")
measure: Efficacy on anxiety on the following day: NRS
time frame: 1 day
description: Self-assessment of anxiety using the numeric rating scale (NRS), on which patients rate their current anxiety from 0 ("no anxiety") to 10 ("worst possible anxiety")
measure: Collection of possible side effects
time frame: 1 day
description: Open question
arm group label: Scenar application
arm group type: Experimental
description: Application of SCENAR device on
arm group label: Scenar application with the device off
arm group type: Placebo Comparator
description: Application of SCENAR device off
intervention type: Device
intervention name: SCENAR application
description: Active SCENAR application on the painful area
arm group label: Scenar application
intervention type: Device
intervention name: SCENAR application with the device off
description: Placebo SCENAR application on the painful area
arm group label: Scenar application with the device off
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Marc Fischler, MD PhD
role: Study Director
affiliation: Hopital Foch
facility: 
country: France
responsible party type: Sponsor
mesh term: Syndrome
mesh term: Somatoform Disorders
sharing ipd: No