<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/NCT03823729</url>
  </required_header>
  <id_info>
    <org_study_id>ELO-02-17</org_study_id>
    <nct_id>NCT03823729</nct_id>
  </id_info>
  <brief_title>Elosan Efficacy Study (EES)</brief_title>
  <official_title>A Randomized, Open, Comparative Clinical Investigation to Show the Efficacy of a Short Time, Whole Body, Electrostatic High Voltage Application for Relief of Chronic Pain. Included in Study Can be Persons Suffering From Chronic Pain as it is Often Case With Rheumatic Disease or Traumata</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Elosan AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Elosan AG</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 &quot;Elosan Cabin&quot; is a closed, electrically insulated, biocompatible cabin for the&#xD;
      short-term application of electrostatic high voltage in patients with chronic pain,&#xD;
      especially those with rheumatic diseases. Patients assigned to the Elosan group (group A)&#xD;
      will have 8 sessions in the Elosan cabin, with an interval of 3 to 4 days between sessions.&#xD;
      Patients assigned to the control group (group B) will have no treatment except for the&#xD;
      continuation of their prescribed pain medication and pain therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Included in the study can be all persons suffering from chronic pain, as it is often the case&#xD;
      with rheumatic disease or traumata. The Elosan therapy to be investigated aims to treat&#xD;
      chronic pain by applying an electrical charge to the body surface and by disruption of&#xD;
      positive bio-feedback to restore physiological reflex relations between the periphery and the&#xD;
      central regulation. The electric charge is created by a generator which can produce an&#xD;
      electrostatic field. The electrical voltage is delivered to the hands via a metal handle in a&#xD;
      closed cabin and is spread over the entire body surface.&#xD;
&#xD;
      A total number of 42 patients will be included into this trial in order to show a&#xD;
      statistically significant reduction of pain compared to reduction of pain in the control&#xD;
      group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 18, 2018</start_date>
  <completion_date type="Actual">March 1, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</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>
    <intervention_model_description>Patients assigned to the Elosan group (group A) will have 8 sessions in the Elosan cabin, with an interval of 3 to 4 days between sessions. Patients assigned to the control group (group B) will have no treatment except for the continuation of their prescribed pain medication and pain therapy.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Pain Intensity is being assessed by Visual Analogue Scale (VAS).</measure>
    <time_frame>Change from Baseline Intensity of pain at 4 weeks</time_frame>
    <description>Change of Pain Intensity is being assessed on a horizontal 100 mm VAS (Visual Analogue Scale) pain scale. The total range of this scale is 100 mm. Minimum score is 0 mm, Maximum score is 100 mm. The higher values represent a higher intensity of pain. The values at baseline will be compared to the values at Visit 8 and the mean of the differences will be compared between the 2 treatment arms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life is being assessed by SF 12 Questionnaire (The 12-Item Short Form Health Survey)</measure>
    <time_frame>Change from Baseline at 4 weeks</time_frame>
    <description>The change in quality of life (as reported by SF 12 questionnaires) from baseline to end of treatment (Day 28) will be compared between the treatment groups. The impact of the changes in summary scores (NBS: Norm-Based-Scoring) of physical health (PCS) and mental health (MCS) will be assessed by a General Linear Model (GLM) using the treatment as fixed factors and the baseline PCS and MCS as covariates, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain medication / pain therapy and any changes thereof shall be recorded during the study.</measure>
    <time_frame>before and after 4 weeks of treatment</time_frame>
    <description>The pain medication taken at baseline will be compared to the amount of pain medication taken at the end of treatment. Changes in pain medication will be qualified by the investigators as either being clinically relevant or not.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Elosan Cabin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with Elosan cabin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Continuation of taking pain medication as prescribed before study start.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Elosan Cabin</intervention_name>
    <description>The Elosan Cabin is a closed, electrically insulated, biocompatible cabin for the short-term application of electrostatic high voltage. Patients assigned to the Group A will have 8 sessions in the Elosan cabin, with an interval of 3 to 4 days between sessions.</description>
    <arm_group_label>Elosan Cabin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed Consent&#xD;
&#xD;
          -  adults, age ≥ 18 years, male or female patients&#xD;
&#xD;
          -  History of pain ≥ 6 months&#xD;
&#xD;
          -  Suffering from chronic pain, either reumatic pain or pain caused by traumata&#xD;
&#xD;
          -  Intensity of pain rated ≥ 50 mm on VAS pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Untreated thyroid disease&#xD;
&#xD;
          -  History of seizure disorder (epilepsy)&#xD;
&#xD;
          -  History of or current psychosis&#xD;
&#xD;
          -  Women who are pregnant, breast feeding or intending to become pregnant&#xD;
&#xD;
          -  Patients who are currently participating in other studies or have participated in&#xD;
             other studies within the last 30 days&#xD;
&#xD;
          -  Patients who have expressed their intention, or are suspected of intending, to&#xD;
             discontinue therapy or stop therapy before the end of trial&#xD;
&#xD;
          -  Patients with an electric or electronic implant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Polymedes Pain Center</name>
      <address>
        <city>Bad Ragaz</city>
        <state>CH</state>
        <zip>7310</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Ortho-Bio-Med</name>
      <address>
        <city>Roveredo</city>
        <state>CH</state>
        <zip>6535</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zentrum für Neurochirurgie Hirslanden Ostschweiz</name>
      <address>
        <city>St.Gallen</city>
        <state>CH</state>
        <zip>9016</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>March 12, 2019</last_update_submitted>
  <last_update_submitted_qc>March 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</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/NCT03823729
org study id: ELO-02-17
nct id: NCT03823729
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The "Elosan Cabin" is a closed, electrically insulated, biocompatible cabin for the
      short-term application of electrostatic high voltage in patients with chronic pain,
      especially those with rheumatic diseases. Patients assigned to the Elosan group (group A)
      will have 8 sessions in the Elosan cabin, with an interval of 3 to 4 days between sessions.
      Patients assigned to the control group (group B) will have no treatment except for the
      continuation of their prescribed pain medication and pain therapy.
Included in the study can be all persons suffering from chronic pain, as it is often the case
      with rheumatic disease or traumata. The Elosan therapy to be investigated aims to treat
      chronic pain by applying an electrical charge to the body surface and by disruption of
      positive bio-feedback to restore physiological reflex relations between the periphery and the
      central regulation. The electric charge is created by a generator which can produce an
      electrostatic field. The electrical voltage is delivered to the hands via a metal handle in a
      closed cabin and is spread over the entire body surface.

      A total number of 42 patients will be included into this trial in order to show a
      statistically significant reduction of pain compared to reduction of pain in the control
      group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients assigned to the Elosan group (group A) will have 8 sessions in the Elosan cabin, with an interval of 3 to 4 days between sessions. Patients assigned to the control group (group B) will have no treatment except for the continuation of their prescribed pain medication and pain therapy.
primary purpose: Treatment
masking: None (Open Label)
measure: Change of Pain Intensity is being assessed by Visual Analogue Scale (VAS).
time frame: Change from Baseline Intensity of pain at 4 weeks
description: Change of Pain Intensity is being assessed on a horizontal 100 mm VAS (Visual Analogue Scale) pain scale. The total range of this scale is 100 mm. Minimum score is 0 mm, Maximum score is 100 mm. The higher values represent a higher intensity of pain. The values at baseline will be compared to the values at Visit 8 and the mean of the differences will be compared between the 2 treatment arms.
measure: Change in quality of life is being assessed by SF 12 Questionnaire (The 12-Item Short Form Health Survey)
time frame: Change from Baseline at 4 weeks
description: The change in quality of life (as reported by SF 12 questionnaires) from baseline to end of treatment (Day 28) will be compared between the treatment groups. The impact of the changes in summary scores (NBS: Norm-Based-Scoring) of physical health (PCS) and mental health (MCS) will be assessed by a General Linear Model (GLM) using the treatment as fixed factors and the baseline PCS and MCS as covariates, respectively.
measure: Pain medication / pain therapy and any changes thereof shall be recorded during the study.
time frame: before and after 4 weeks of treatment
description: The pain medication taken at baseline will be compared to the amount of pain medication taken at the end of treatment. Changes in pain medication will be qualified by the investigators as either being clinically relevant or not.
arm group label: Elosan Cabin
arm group type: Experimental
description: Treatment with Elosan cabin
arm group label: No Treatment
arm group type: No Intervention
description: Continuation of taking pain medication as prescribed before study start.
intervention type: Device
intervention name: Elosan Cabin
description: The Elosan Cabin is a closed, electrically insulated, biocompatible cabin for the short-term application of electrostatic high voltage. Patients assigned to the Group A will have 8 sessions in the Elosan cabin, with an interval of 3 to 4 days between sessions.
arm group label: Elosan Cabin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Chronic Pain
sharing ipd: No