<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/NCT04415177</url>
  </required_header>
  <id_info>
    <org_study_id>2020-521</org_study_id>
    <nct_id>NCT04415177</nct_id>
  </id_info>
  <brief_title>Virtual Reality Trial Using EaseVRx For Chronic Low Back Pain</brief_title>
  <official_title>Safety and Effectiveness of Virtual Reality Utilizing EaseVRx for the Reduction of Chronic Pain and Opioid Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AppliedVR Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AppliedVR Inc.</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized, 2-arm parallel group clinical trial evaluating the effectiveness of a&#xD;
      self-administered Virtual Reality program for the treatment of chronic lower back pain&#xD;
      compared to a placebo VR program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, 2-arm parallel-group clinical trial evaluating the effectiveness of a&#xD;
      self-administered Virtual Reality (VR) program for the treatment of chronic lower back pain.&#xD;
      The primary objective of this study is to assess the impact of skills-based VR on changes in&#xD;
      patient-reported pain and pain interference over the course of an 8-week intervention as well&#xD;
      as compared to a placebo VR condition. The secondary objective is to assess the impact of&#xD;
      skill-based VR on changes in patient-reported satisfaction over the course of an 8-week&#xD;
      intervention and compared to a placebo VR condition. A tertiary objective is to assess the&#xD;
      impact of skills-based VR on changes in patient-reported opioid use, physical function,&#xD;
      behavioral skills development, and health outcomes immediately following the intervention&#xD;
      relative to a pre-intervention baseline and compared to a placebo VR condition. An&#xD;
      exploratory objective is to assess the impact of skills-based VR on changes in&#xD;
      patient-reported pain levels, opioid use, physical function, behavioral skills development,&#xD;
      health outcomes, and satisfaction at the 24-week post-intervention time point and compared to&#xD;
      a placebo VR condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Department of Defense (DoD)/VA Pain scale</measure>
    <time_frame>The primary efficacy endpoint is the change from study baseline to Day 56</time_frame>
    <description>DoD/VA Pain scale measures pain intensity, and inference around activity, sleep, mood, and stress, each on an 11-point scale. The max score is 50 and the minimum is 0. The higher the score the worse the outcome. This will be assessed twice weekly during the 8-week intervention intervention period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient's Global Impression of Change Scale</measure>
    <time_frame>twice weekly during 8-week intervention, Day 56</time_frame>
    <description>Single item Patient's Global Impression of Change Scale (PGIC), self-reported the level of change (if any) in activity limitations, symptoms, emotions, and overall quality of life-related to your painful condition on a 7-point scale. The higher the number the better the outcome.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Device utilization Questionnaire</measure>
    <time_frame>twice weekly during 8-week intervention, Day 56</time_frame>
    <description>Self-reported number of VR sessions completed since the participant last reported. The scale is 0-4 or more. The higher than number the higher the usage.</description>
  </other_outcome>
  <other_outcome>
    <measure>VR Satisfaction Scale</measure>
    <time_frame>Day 56</time_frame>
    <description>Satisfaction ratings regarding the ability of the VR program to relieve pain symptoms on a 5-point scale. One is defined as strongly disagree with the statement and five is defined as strongly agree. The higher the number the better the outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Custom Opioid Use Survey</measure>
    <time_frame>Baseline, Day 56</time_frame>
    <description>Custom survey assesses the use of opioids, frequency of use, dose of medication, happiness with regimen, and interest in change in treatment.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function</measure>
    <time_frame>Baseline, Day 56</time_frame>
    <description>This 6-item PROMIS physical function measure assesses physical function such as (chores, running errands) on a 5-point scale. The max score is 30 and the minimum is 6. The higher the score the better the outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance</measure>
    <time_frame>Baseline, Day 56</time_frame>
    <description>6-item PROMIS sleep disturbance measure assesses the level of sleep disturbance on a 5-point scale. The max score is 30 and the minimum is 6. The higher the score the worse the outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain Self-efficacy Questionnaire</measure>
    <time_frame>Baseline, Day 56</time_frame>
    <description>2-item PSEQ (PSEQ-2) assesses pain self-efficacy on a 7-point scale. The max score is 12 and the minimum is 0. The higher the score the better the outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain Catastrophizing Scale</measure>
    <time_frame>Baseline, Day 56</time_frame>
    <description>4 items from the Pain Catastrophizing Scale (PCS) assesses frequency of pain-related thoughts and feelings on a 5-point scale. The max score is 16 and the minimum is 0. The higher the score the worse the outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Chronic Pain Acceptance Questionnaire</measure>
    <time_frame>Baseline, Day 56</time_frame>
    <description>8-item Chronic Pain Acceptance (CPAQ-8) questionnaire assesses acceptance or psychological flexibility associated with chronic pain on a 7-point scale. The max score is 56 and the minimum is 8. The higher the score the better the outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Behavioral Skills Assessment</measure>
    <time_frame>Day 56</time_frame>
    <description>Custom survey assesses the development of skills to manage pain outside of the VR headset. This is only included in the EaseVRx condition. There are 4 knowledge questions. These are on a 1-5 scale from do not agree to completely agree. The skills questions are on a 0 to 10 scale with 0 being not at all confident and 10 being very confident.</description>
  </other_outcome>
  <other_outcome>
    <measure>Health Utilization Outcomes Questionnaire</measure>
    <time_frame>Day 56</time_frame>
    <description>Questionnaire on the frequency of steroid injections, lower back surgery, emergency department visits, hospital admissions, and unplanned physician visits over various time periods. The first part of each of these questions asks if they have had the service and then the second part asks for the frequency.</description>
  </other_outcome>
  <other_outcome>
    <measure>VR Use Data</measure>
    <time_frame>Day 1 through Day 56</time_frame>
    <description>VR use calculated as the total number of sessions launched. It will be continuous data stored on the headset.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">188</enrollment>
  <condition>Chronic Lower Back Pain</condition>
  <arm_group>
    <arm_group_label>VR Program A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Software with active intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VR Program B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Software without active intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EaseVRx headset with active intervention</intervention_name>
    <description>VR software developed by AppliedVR informed by evidence-based cognitive behavioral therapy principles, biofeedback and mindfulness strategies for pain management.</description>
    <arm_group_label>VR Program A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EaseVRx headset without active intervention</intervention_name>
    <description>VR software developed by AppliedVR with neutral non-interactive content.</description>
    <arm_group_label>VR Program B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women 18-85 years old&#xD;
&#xD;
          -  Diagnosis of low back pain without radicular symptoms&#xD;
&#xD;
          -  Pain duration of at least 6 months&#xD;
&#xD;
          -  Average pain intensity of at least 4 on the 0-10 DoD/VA Pain Scale for the past month&#xD;
             at screening&#xD;
&#xD;
          -  English fluency&#xD;
&#xD;
          -  Willing to comply with study procedures/restrictions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to understand the goals of the study due to cognitive difficulty&#xD;
&#xD;
          -  Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines or other&#xD;
             neurological disease that may prevent the use of VR&#xD;
&#xD;
          -  Medical condition predisposing to nausea or dizziness&#xD;
&#xD;
          -  Hypersensitivity to flashing light or motion&#xD;
&#xD;
          -  No stereoscopic vision or severe hearing impairment&#xD;
&#xD;
          -  Injury to eyes, face or neck that prevents comfortable use of VR&#xD;
&#xD;
          -  Pain related to cancer&#xD;
&#xD;
          -  Active suicidal ideation or severe depression&#xD;
&#xD;
          -  Previous use of EaseVR for pain&#xD;
&#xD;
          -  Current participation in any interventional research study or completed participation&#xD;
             in past 2 months&#xD;
&#xD;
          -  Currently pregnant or planning to become pregnant&#xD;
&#xD;
          -  Does not have access to WIFI during participation in study&#xD;
&#xD;
          -  Currently works at or has an immediate family member who works for a digital health&#xD;
             company or pharmaceutical company that provides treatments for acute or chronic pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura Garcia, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AppliedVR Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AppliedVR, Inc.</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://appliedvr.io/study-enrollment/</url>
    <description>webpage to assess if the study is right for you</description>
  </link>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>January 7, 2022</last_update_submitted>
  <last_update_submitted_qc>January 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Virtual Reality</keyword>
  <keyword>Chronic Lower Back Pain</keyword>
  <keyword>Analgesia</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>
  <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/NCT04415177
org study id: 2020-521
nct id: NCT04415177
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Randomized, 2-arm parallel group clinical trial evaluating the effectiveness of a
      self-administered Virtual Reality program for the treatment of chronic lower back pain
      compared to a placebo VR program.
A randomized, 2-arm parallel-group clinical trial evaluating the effectiveness of a
      self-administered Virtual Reality (VR) program for the treatment of chronic lower back pain.
      The primary objective of this study is to assess the impact of skills-based VR on changes in
      patient-reported pain and pain interference over the course of an 8-week intervention as well
      as compared to a placebo VR condition. The secondary objective is to assess the impact of
      skill-based VR on changes in patient-reported satisfaction over the course of an 8-week
      intervention and compared to a placebo VR condition. A tertiary objective is to assess the
      impact of skills-based VR on changes in patient-reported opioid use, physical function,
      behavioral skills development, and health outcomes immediately following the intervention
      relative to a pre-intervention baseline and compared to a placebo VR condition. An
      exploratory objective is to assess the impact of skills-based VR on changes in
      patient-reported pain levels, opioid use, physical function, behavioral skills development,
      health outcomes, and satisfaction at the 24-week post-intervention time point and compared to
      a placebo VR condition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Department of Defense (DoD)/VA Pain scale
time frame: The primary efficacy endpoint is the change from study baseline to Day 56
description: DoD/VA Pain scale measures pain intensity, and inference around activity, sleep, mood, and stress, each on an 11-point scale. The max score is 50 and the minimum is 0. The higher the score the worse the outcome. This will be assessed twice weekly during the 8-week intervention intervention period.
measure: Patient's Global Impression of Change Scale
time frame: twice weekly during 8-week intervention, Day 56
description: Single item Patient's Global Impression of Change Scale (PGIC), self-reported the level of change (if any) in activity limitations, symptoms, emotions, and overall quality of life-related to your painful condition on a 7-point scale. The higher the number the better the outcome.
measure: Device utilization Questionnaire
time frame: twice weekly during 8-week intervention, Day 56
description: Self-reported number of VR sessions completed since the participant last reported. The scale is 0-4 or more. The higher than number the higher the usage.
measure: VR Satisfaction Scale
time frame: Day 56
description: Satisfaction ratings regarding the ability of the VR program to relieve pain symptoms on a 5-point scale. One is defined as strongly disagree with the statement and five is defined as strongly agree. The higher the number the better the outcome.
measure: Custom Opioid Use Survey
time frame: Baseline, Day 56
description: Custom survey assesses the use of opioids, frequency of use, dose of medication, happiness with regimen, and interest in change in treatment.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
time frame: Baseline, Day 56
description: This 6-item PROMIS physical function measure assesses physical function such as (chores, running errands) on a 5-point scale. The max score is 30 and the minimum is 6. The higher the score the better the outcome.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance
time frame: Baseline, Day 56
description: 6-item PROMIS sleep disturbance measure assesses the level of sleep disturbance on a 5-point scale. The max score is 30 and the minimum is 6. The higher the score the worse the outcome.
measure: Pain Self-efficacy Questionnaire
time frame: Baseline, Day 56
description: 2-item PSEQ (PSEQ-2) assesses pain self-efficacy on a 7-point scale. The max score is 12 and the minimum is 0. The higher the score the better the outcome.
measure: Pain Catastrophizing Scale
time frame: Baseline, Day 56
description: 4 items from the Pain Catastrophizing Scale (PCS) assesses frequency of pain-related thoughts and feelings on a 5-point scale. The max score is 16 and the minimum is 0. The higher the score the worse the outcome.
measure: Chronic Pain Acceptance Questionnaire
time frame: Baseline, Day 56
description: 8-item Chronic Pain Acceptance (CPAQ-8) questionnaire assesses acceptance or psychological flexibility associated with chronic pain on a 7-point scale. The max score is 56 and the minimum is 8. The higher the score the better the outcome.
measure: Behavioral Skills Assessment
time frame: Day 56
description: Custom survey assesses the development of skills to manage pain outside of the VR headset. This is only included in the EaseVRx condition. There are 4 knowledge questions. These are on a 1-5 scale from do not agree to completely agree. The skills questions are on a 0 to 10 scale with 0 being not at all confident and 10 being very confident.
measure: Health Utilization Outcomes Questionnaire
time frame: Day 56
description: Questionnaire on the frequency of steroid injections, lower back surgery, emergency department visits, hospital admissions, and unplanned physician visits over various time periods. The first part of each of these questions asks if they have had the service and then the second part asks for the frequency.
measure: VR Use Data
time frame: Day 1 through Day 56
description: VR use calculated as the total number of sessions launched. It will be continuous data stored on the headset.
arm group label: VR Program A
arm group type: Experimental
description: Software with active intervention
arm group label: VR Program B
arm group type: Active Comparator
description: Software without active intervention
intervention type: Device
intervention name: EaseVRx headset with active intervention
description: VR software developed by AppliedVR informed by evidence-based cognitive behavioral therapy principles, biofeedback and mindfulness strategies for pain management.
arm group label: VR Program A
intervention type: Device
intervention name: EaseVRx headset without active intervention
description: VR software developed by AppliedVR with neutral non-interactive content.
arm group label: VR Program B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Laura Garcia, PhD
role: Principal Investigator
affiliation: AppliedVR Inc.
facility: 
country: United States
url: https://appliedvr.io/study-enrollment/
description: webpage to assess if the study is right for you
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No