<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/NCT03776019</url>
  </required_header>
  <id_info>
    <org_study_id>AVWF 2019</org_study_id>
    <nct_id>NCT03776019</nct_id>
  </id_info>
  <brief_title>Efficacy of Audio-Visual-Perception-Enhancement (AVWF®) Method in Chronic Pain Patients</brief_title>
  <official_title>Efficacy of Audio-Visual-Perception-Enhancement (AVWF®) Method in Chronic Pain Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Klinikum Klagenfurt am Wörthersee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Klinikum Klagenfurt am Wörthersee</source>
  <oversight_info>
    <has_dmc>Yes</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>
      It is anticipated that Audio-Visual-Perception-Enhancement (AVWF®) method leads to pain&#xD;
      reduction and a decrease of inflammatory markers in chronic pain patients. Also an&#xD;
      improvement of quality of life, self-perceived disability and depression in chronic pain&#xD;
      patients is expected.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Actual">December 20, 2019</completion_date>
  <primary_completion_date type="Actual">December 20, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Numeric Rating Scale of Pain Severity</measure>
    <time_frame>Change from baseline Numeric Rating Scale of Pain Severity after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention</time_frame>
    <description>Validated 11 pt scale 0-10, to evaluate a patient's current severity of pain. A rating of 0 indicates no pain while 10 indicates the worst pain imaginable. A score of 4 or above is considered a clinically significant pain Level.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>Change from baseline health related quality of life after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention</time_frame>
    <description>Health related quality of life will be measured by euroQol-5D questionnaire. It contains two sections, a descriptive section and a valuation section</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale</measure>
    <time_frame>Change from baseline Hospital Anxiety and Depression Scale after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention</time_frame>
    <description>Anxiety and depression is evaluated by the the Hospital Anxiety and Depression Scale.It contains 14 items describing symptoms of depression (7 items) and anxiety (7 items). It was developed to identify anxiety and depression in non-psychiatric medical outpatients. Each item on the HADS is scored from 0 (no problem) to 3 (maximum distress).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pittsburgh Sleep Quality Index</measure>
    <time_frame>Change from baseline Pittsburgh Sleep Quality Index after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention</time_frame>
    <description>Self-report questionnaire that assesses sleep Quality through the measure of 19 individual items, creating 7 components that produce one global score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Anxiety Stress Scales</measure>
    <time_frame>Change from baseline Depression Anxiety Stress Scales after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention</time_frame>
    <description>A 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Disability Index</measure>
    <time_frame>Change from baseline Pain Disability Index after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention</time_frame>
    <description>The Pain Disability Index is an instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. Minimal index: 0; maximal index: 70; The higher the index the greater the person's disability due to pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salival Cortisol level</measure>
    <time_frame>Change from baseline salival cortisol level after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention</time_frame>
    <description>Immunoassay for in vitro quantitative determination of cortisol in saliva</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Pain</condition>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>Modulated</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>modulated music</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Typical</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>typical music</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AVWF device</intervention_name>
    <description>The AVWF method utilizes sound modulated music, which is thought to regulate the vagus nerve.</description>
    <arm_group_label>Modulated</arm_group_label>
    <arm_group_label>Typical</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic low back pain with a numeric rating scale of pain &gt;= 4 for &gt; 6 month&#xD;
&#xD;
          -  patients &gt;18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  psychosis&#xD;
&#xD;
          -  drug addiction&#xD;
&#xD;
          -  pension process&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  epilepsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rudolf Likar</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head of department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinikum Klagenfurt am Wörthersee</name>
      <address>
        <city>Klagenfurt</city>
        <zip>9020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>September 8, 2020</last_update_submitted>
  <last_update_submitted_qc>September 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Klinikum Klagenfurt am Wörthersee</investigator_affiliation>
    <investigator_full_name>Rudolf Likar</investigator_full_name>
    <investigator_title>Prim.Univ.Prof.Dr.</investigator_title>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>Stress</keyword>
  <keyword>AVWF</keyword>
  <keyword>Audio-Visual-Perception-Enhancement</keyword>
  <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/NCT03776019
org study id: AVWF 2019
nct id: NCT03776019
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
It is anticipated that Audio-Visual-Perception-Enhancement (AVWF®) method leads to pain
      reduction and a decrease of inflammatory markers in chronic pain patients. Also an
      improvement of quality of life, self-perceived disability and depression in chronic pain
      patients is expected.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in Numeric Rating Scale of Pain Severity
time frame: Change from baseline Numeric Rating Scale of Pain Severity after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention
description: Validated 11 pt scale 0-10, to evaluate a patient's current severity of pain. A rating of 0 indicates no pain while 10 indicates the worst pain imaginable. A score of 4 or above is considered a clinically significant pain Level.
measure: Health related quality of life
time frame: Change from baseline health related quality of life after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention
description: Health related quality of life will be measured by euroQol-5D questionnaire. It contains two sections, a descriptive section and a valuation section
measure: Hospital Anxiety and Depression Scale
time frame: Change from baseline Hospital Anxiety and Depression Scale after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention
description: Anxiety and depression is evaluated by the the Hospital Anxiety and Depression Scale.It contains 14 items describing symptoms of depression (7 items) and anxiety (7 items). It was developed to identify anxiety and depression in non-psychiatric medical outpatients. Each item on the HADS is scored from 0 (no problem) to 3 (maximum distress).
measure: Pittsburgh Sleep Quality Index
time frame: Change from baseline Pittsburgh Sleep Quality Index after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention
description: Self-report questionnaire that assesses sleep Quality through the measure of 19 individual items, creating 7 components that produce one global score
measure: Depression Anxiety Stress Scales
time frame: Change from baseline Depression Anxiety Stress Scales after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention
description: A 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress.
measure: Pain Disability Index
time frame: Change from baseline Pain Disability Index after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention
description: The Pain Disability Index is an instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. Minimal index: 0; maximal index: 70; The higher the index the greater the person's disability due to pain
measure: Salival Cortisol level
time frame: Change from baseline salival cortisol level after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention
description: Immunoassay for in vitro quantitative determination of cortisol in saliva
arm group label: Modulated
arm group type: Experimental
description: modulated music
arm group label: Typical
arm group type: Sham Comparator
description: typical music
intervention type: Device
intervention name: AVWF device
description: The AVWF method utilizes sound modulated music, which is thought to regulate the vagus nerve.
arm group label: Modulated
arm group label: Typical
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Rudolf Likar
role: Principal Investigator
affiliation: Head of department
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Klinikum Klagenfurt am Wörthersee
investigator full name: Rudolf Likar
investigator title: Prim.Univ.Prof.Dr.
mesh term: Chronic Pain
sharing ipd: No