<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/NCT04503889</url>
  </required_header>
  <id_info>
    <org_study_id>BB 095/16</org_study_id>
    <nct_id>NCT04503889</nct_id>
  </id_info>
  <brief_title>The Effect of Transauricular Electrical Vagal Nerve Stimulation on Temporal Summation of Pain in Patients With Back Pain</brief_title>
  <acronym>TVNS_TSP_LBP</acronym>
  <official_title>The Effect of Transauricular Electrical Vagal Nerve Stimulation on Temporal Summation of Heat Pain in Patients With Chronic Low-back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medicine Greifswald</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medicine Greifswald</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>
      The effect of transauricular electrical vagal nerve stimulation (taVNS) will be studied on&#xD;
      temporal summation of heat pain (TSP) in 30 patients with chronic low-back pain and in 30&#xD;
      heathy volunteers. Participants will receive either taVNS or sham stimulation before and&#xD;
      during TSP induction in a randomized crossover manner. The participants will be unaware&#xD;
      regarding the type of intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 23, 2019</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 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>Basic Science</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Participants and outcome assessor will be unaware regarding the type (real or sham) taVNS intervention</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Unpleasantness of pain</measure>
    <time_frame>Continuously 5 minutes during the experimental heat pain stimulation</time_frame>
    <description>Perceived unpleasantness of pain, which participants will rate continuously during the repetitive heat stimulation using a computerized visual analogue scale (CoVAS, Medoc Advanced Medical Systems, Ramat Yishai, Israel) ranging from 0 (= not unpleasant at all) to 100 (= intolerable pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>10 minutes (before, during and after stimulation of heat pain)</time_frame>
    <description>Heart rate (bpm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood pressure</measure>
    <time_frame>10 minutes (before, during and after stimulation of heat pain)</time_frame>
    <description>non-invasive measurement of systolic and diastolic blood pressure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Pain Intensity</condition>
  <arm_group>
    <arm_group_label>Real taVNS intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>taVNS will be administered to cymba conchae of both ears using ECO2-TENS device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>aVNS will be administered to lobes of both ears using ECO2-TENS device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transauricular electrical vagal nerve stimulation</intervention_name>
    <description>transauricular electrical vagal nerve stimulation will be applied to the cymba conchae of both ears using ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany) with currency intensity of max 10 mA and current frequency 2/100 Hz.</description>
    <arm_group_label>Real taVNS intervention</arm_group_label>
    <arm_group_label>Sham</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>taVNS sham</intervention_name>
    <description>ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany)</description>
    <arm_group_label>Real taVNS intervention</arm_group_label>
    <arm_group_label>Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with chronic low-back pain&#xD;
&#xD;
          -  age 30-60 yrs old&#xD;
&#xD;
          -  without heart disease&#xD;
&#xD;
          -  low-back pain intensity at least 4 out of 10 points measured using NRS-10&#xD;
&#xD;
          -  without cognitive deficits (Mini Mental State Shake &lt; 23)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  opioid medication&#xD;
&#xD;
          -  more than 1 low-back surgery&#xD;
&#xD;
          -  sensory of motor neurological deficits at the level of back pain&#xD;
&#xD;
          -  spinal stenosis&#xD;
&#xD;
          -  diabetic polyneuropathy&#xD;
&#xD;
          -  skin pathology at the site (cymba conchae) of stimulation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Taras Usichenko, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University Medicine of Greifswald</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Taras Usichenko, MD. PhD</last_name>
    <phone>+49 383486</phone>
    <phone_ext>5893</phone_ext>
    <email>taras@uni-greifswald.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>David Naegele</last_name>
    <email>david.naegele@uni-greifswald.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Medicine of Greifswald</name>
      <address>
        <city>Greifswald</city>
        <zip>17475</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Taras Usichenko, MD, hD</last_name>
      <phone>+49383486</phone>
      <phone_ext>5893</phone_ext>
      <email>taras@uni-greifswald.de</email>
    </contact>
    <contact_backup>
      <last_name>David Naegele</last_name>
      <email>david.naegele@uni-greifswald.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</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>Back Pain</mesh_term>
    <mesh_term>Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04503889
org study id: BB 095/16
nct id: NCT04503889
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The effect of transauricular electrical vagal nerve stimulation (taVNS) will be studied on
      temporal summation of heat pain (TSP) in 30 patients with chronic low-back pain and in 30
      heathy volunteers. Participants will receive either taVNS or sham stimulation before and
      during TSP induction in a randomized crossover manner. The participants will be unaware
      regarding the type of intervention.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Outcomes Assessor)
masking description: Participants and outcome assessor will be unaware regarding the type (real or sham) taVNS intervention
measure: Unpleasantness of pain
time frame: Continuously 5 minutes during the experimental heat pain stimulation
description: Perceived unpleasantness of pain, which participants will rate continuously during the repetitive heat stimulation using a computerized visual analogue scale (CoVAS, Medoc Advanced Medical Systems, Ramat Yishai, Israel) ranging from 0 (= not unpleasant at all) to 100 (= intolerable pain)
measure: Heart rate
time frame: 10 minutes (before, during and after stimulation of heat pain)
description: Heart rate (bpm)
measure: blood pressure
time frame: 10 minutes (before, during and after stimulation of heat pain)
description: non-invasive measurement of systolic and diastolic blood pressure
arm group label: Real taVNS intervention
arm group type: Experimental
description: taVNS will be administered to cymba conchae of both ears using ECO2-TENS device
arm group label: Sham
arm group type: Sham Comparator
description: aVNS will be administered to lobes of both ears using ECO2-TENS device
intervention type: Device
intervention name: Transauricular electrical vagal nerve stimulation
description: transauricular electrical vagal nerve stimulation will be applied to the cymba conchae of both ears using ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany) with currency intensity of max 10 mA and current frequency 2/100 Hz.
arm group label: Real taVNS intervention
arm group label: Sham
intervention type: Device
intervention name: taVNS sham
description: ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany)
arm group label: Real taVNS intervention
arm group label: Sham
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Taras Usichenko, MD, PhD
role: Study Chair
affiliation: University Medicine of Greifswald
last name: Taras Usichenko, MD. PhD
phone: +49 383486
phone ext: 5893
email: taras@uni-greifswald.de
last name: David Naegele
email: david.naegele@uni-greifswald.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Pain
sharing ipd: Undecided