<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/NCT04409353</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00000631</org_study_id>
    <secondary_id>1UG3AR076573-01</secondary_id>
    <nct_id>NCT04409353</nct_id>
  </id_info>
  <brief_title>Virtual Reality Therapy for Chronic Low Back Pain</brief_title>
  <official_title>Randomized-controlled Trial of Virtual Reality for Chronic Low Back Pain to Improve Patient-reported Outcomes and Physical Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will test the effectiveness of an evidence-based virtual reality therapy program&#xD;
      as a non-pharmacological supplement to managing patients with pain due to chronic lower back&#xD;
      pain. Outpatients will be randomized to receive one of three virtual reality (VR) programs:&#xD;
      skills-based VR, distraction VR, or sham VR. All patients will receive a VR headset and&#xD;
      Fitbit Charge 4 watch. Study devices will be delivered to the patient's home with&#xD;
      instructions for use via FedEx; patients will receive remote technical support. Patients will&#xD;
      be followed for 90 days and monitored for functional status, pain levels, use of pain&#xD;
      medications (including opioids). Participants will also be asked to consent/authorization to&#xD;
      access medical records from their treating facility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized double-blind, placebo-controlled trial for individuals with chronic&#xD;
      lower back pain. This study investigates the effect of at-home virtual reality (VR) pain&#xD;
      reduction therapy on a set of outcome measures. The primary outcome is Patient-Reported&#xD;
      Outcomes Measurement Information System (PROMIS) Pain Interference version 8. This study will&#xD;
      enroll 360 participants into one of three VR therapy groups. Data collection will occur at&#xD;
      home via personal computer or smartphone (iphone/android), with baseline data collected one&#xD;
      week before the intervention is mailed to the patient. The patient will have the VR headset&#xD;
      for 90 days. A post-study survey will be sent to patients 30 days after the end of the study.&#xD;
&#xD;
      To learn more about the study and to assess your eligibility, please visit our study website&#xD;
      at https://virtualmedicine.org/research/current/vr4backpain&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 21, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System Pain Interference</measure>
    <time_frame>This will be measured weekly for the first 4 weeks. The primary efficacy endpoint is the change from study baseline (Screening week, aka week -1) to week 4 in pain interference as measured by PROMIS-PI.</time_frame>
    <description>The primary outcome for this study will be self-reported pain interference using Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) version 8. The pain interference scale measures the consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. It is the 8 question version. The max score is 40 and the minimum is 8. The higher the score the worse the outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System Pain Interference 8</measure>
    <time_frame>biweekly from week 6 to week 12</time_frame>
    <description>PROMIS Pain Interference 8 will also be assessed after the first month of the study at a biweekly interval. As stated above the pain interference scale measures the consequences of pain on relevant aspects of one's life. The max score is 40 and the minimum is 8. The higher the score the worse the outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Catastrophizing Survey Short Form 6</measure>
    <time_frame>biweekly until week 12</time_frame>
    <description>Pain catastrophizing is a negative mental set regarding actual or anticipated pain, and includes aspects of rumination, magnification, and sense of helplessness. It will be measured using the Pain Catastrophizing scale (PCS) short form, which a 6-item questionnaire. The max score is 24 and the minimum is 0. The higher the score the worse the outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System Anxiety 4</measure>
    <time_frame>biweekly until week 12</time_frame>
    <description>Anxiety is a commonly comorbid disease with chronic lower back pain. The PROMIS Anxiety scale will be used to assess it. This is the 4 question version of the scale. The max score is 20 and the minimum is 4. The higher the score the worse the outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System Sleep Disturbance 6a</measure>
    <time_frame>biweekly until week 12</time_frame>
    <description>Given the impact of chronic pain on mental health there is also an impact on sleep. PROMIS Sleep Disturbance is a well-validated survey to assess sleep quality. This is version A of the 6 item scale. The max score is 30 and the minimum is 6. The higher the score the worse the outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Opioids</measure>
    <time_frame>The average for 30 days before Day 1 and the 30 day average at 90 day will be compared within the study.</time_frame>
    <description>In order to capture use of opioids, we will link patient electronic health record (EHR) data to the other data sources using Medical Record Numbers and date of birth. We will also request access to the CURES database for research purposes. We will convert all opioid doses into a single metric using morphine milligram equivalents (MME).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System Physical Function 6b</measure>
    <time_frame>biweekly basis until week 12</time_frame>
    <description>For patients with chronic pain, physical function is often diminished and patients seek return to normal function. The Patient-Reported Outcomes Measurement Information System Physical Function short-form 6b scale is a widely- validated instrument with excellent content validity, construct validity, and reliability in patients with spinal disorders and other conditions marked by diminished mobility. The instrument places patients on a continuum of function from extremely low to very high across activities that require physical actions, ranging from self-care to more complex activities that require a combination of skills. The max score is 30 and the minimum is 6. The higher the score the worse the outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System Depression 4</measure>
    <time_frame>biweekly until week 12</time_frame>
    <description>Depression is a commonly comorbid disease with chronic lower back pain. The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scale will be used to assess it. This is the 4 item version of the scale. The max score is 20 and the minimum is 4. The higher the score the worse the outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Biometric data from Fitbit Charge 4 - Physical Activity</measure>
    <time_frame>Continuously from week 1 to week 12</time_frame>
    <description>The total steps per day per day will be collected to assess physical activity.</description>
  </other_outcome>
  <other_outcome>
    <measure>Biometric data from Fitbit Charge 4 - Sleep Quantity</measure>
    <time_frame>Continuously from week 1 to week 12</time_frame>
    <description>The total hours of sleep per night as well as sleep efficiency will be assessed for the quantity of sleep using the Fitbit charge 4. Data will be analyzed using the Fitabase system.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Chronic Lower Back Pain</condition>
  <arm_group>
    <arm_group_label>Virtual Reality Program A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will include software that provides immersive skills-based content for pain reduction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Virtual Reality Program B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will include software that provides immersive distraction based content for pain reduction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Virtual Reality Program C</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>This arm will include software that provides nonimmersive distraction based content for pain reduction.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PICO G2 4k</intervention_name>
    <description>Participants will use the Pico G2 4K VR audio and visual head-mounted device. The Pico G2 4K is a standalone VR headset that comes with an orientation-tracked controller. It does not require a smartphone or personal computer to operate. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view.</description>
    <arm_group_label>Virtual Reality Program A</arm_group_label>
    <arm_group_label>Virtual Reality Program B</arm_group_label>
    <arm_group_label>Virtual Reality Program C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of signed and dated informed consent form.&#xD;
&#xD;
          2. Stated willingness to comply with all study procedures and availability for the&#xD;
             duration of the study.&#xD;
&#xD;
          3. Male or female, above the age of 13.&#xD;
&#xD;
          4. A back pain problem that has persisted at least 3 months and has resulted in pain on&#xD;
             at least half the days in the past 6 months.&#xD;
&#xD;
          5. English speaking.&#xD;
&#xD;
          6. The participant has either a personal computer or a smartphone (android/iphone) to the&#xD;
             web-based complete surveys.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Are presenting with a condition that interferes with virtual reality usage (e.g.,&#xD;
             history of seizure, facial injury precluding safe placement of headset, visual&#xD;
             impairment, significant hearing impairment impact ability to follow audio&#xD;
             instructions).&#xD;
&#xD;
          2. Are being recommended for long-term hospitalization that would require more than&#xD;
             three-week stay inside the hospital.&#xD;
&#xD;
          3. Received recent surgery within the previous 8 weeks.&#xD;
&#xD;
          4. Any planned surgeries in the next 3 months.&#xD;
&#xD;
          5. Are currently using a spinal cord stimulator.&#xD;
&#xD;
          6. Have lower back pain attributable to a recognizable, specific pathology, such as&#xD;
             infection, tumor, fracture, or inflammatory spondylopathy.&#xD;
&#xD;
          7. Previously participated in a virtual reality clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brennan Spiegel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Samuel Eberlein, MS</last_name>
    <phone>310-423-6721</phone>
    <email>samuel.eberlein@cshs.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zoe Krut, MS</last_name>
    <phone>310-423-0699</phone>
    <email>zoe.krut@cshs.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Samuel Eberlein</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samuel Eberlein</last_name>
      <email>vrstudymail@cshs.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://virtualmedicine.org/research/current/vr4backpain</url>
    <description>Study web portal for more information and a self-assessment for eligibility</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>July 17, 2023</last_update_submitted>
  <last_update_submitted_qc>July 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Brennan Spiegel</investigator_full_name>
    <investigator_title>Staff Physician III</investigator_title>
  </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>Yes</sharing_ipd>
    <ipd_description>This study is part of the NIH Helping to End Addiction Long-term (HEAL) Initiative focused on understanding and developing new treatments for addiction and pain. Research gives us the best information and progresses more quickly when data is available from many studies and many individuals, and when many researchers can work with the data and samples and analyze them in different ways. Therefore, your data and samples will be used for this and other NIH Helping to End Addiction Long-term Initiative studies. Your stored data and samples will also be made widely available to other researchers. The shared data and samples may be used indefinitely for research not related to this study or the Helping to End Addiction Long-term (HELP) Initiative, without asking you for additional consent.</ipd_description>
    <ipd_time_frame>2020 to 2024</ipd_time_frame>
    <ipd_access_criteria>The researcher must be part of the NIH Back Pain Consortium (BACPAC) consortium.</ipd_access_criteria>
  </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/NCT04409353
org study id: Pro00000631
secondary id: 1UG3AR076573-01
nct id: NCT04409353
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This study will test the effectiveness of an evidence-based virtual reality therapy program
      as a non-pharmacological supplement to managing patients with pain due to chronic lower back
      pain. Outpatients will be randomized to receive one of three virtual reality (VR) programs:
      skills-based VR, distraction VR, or sham VR. All patients will receive a VR headset and
      Fitbit Charge 4 watch. Study devices will be delivered to the patient's home with
      instructions for use via FedEx; patients will receive remote technical support. Patients will
      be followed for 90 days and monitored for functional status, pain levels, use of pain
      medications (including opioids). Participants will also be asked to consent/authorization to
      access medical records from their treating facility.
This is a randomized double-blind, placebo-controlled trial for individuals with chronic
      lower back pain. This study investigates the effect of at-home virtual reality (VR) pain
      reduction therapy on a set of outcome measures. The primary outcome is Patient-Reported
      Outcomes Measurement Information System (PROMIS) Pain Interference version 8. This study will
      enroll 360 participants into one of three VR therapy groups. Data collection will occur at
      home via personal computer or smartphone (iphone/android), with baseline data collected one
      week before the intervention is mailed to the patient. The patient will have the VR headset
      for 90 days. A post-study survey will be sent to patients 30 days after the end of the study.

      To learn more about the study and to assess your eligibility, please visit our study website
      at https://virtualmedicine.org/research/current/vr4backpain
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Patient-Reported Outcomes Measurement Information System Pain Interference
time frame: This will be measured weekly for the first 4 weeks. The primary efficacy endpoint is the change from study baseline (Screening week, aka week -1) to week 4 in pain interference as measured by PROMIS-PI.
description: The primary outcome for this study will be self-reported pain interference using Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) version 8. The pain interference scale measures the consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. It is the 8 question version. The max score is 40 and the minimum is 8. The higher the score the worse the outcome.
measure: Patient-Reported Outcomes Measurement Information System Pain Interference 8
time frame: biweekly from week 6 to week 12
description: PROMIS Pain Interference 8 will also be assessed after the first month of the study at a biweekly interval. As stated above the pain interference scale measures the consequences of pain on relevant aspects of one's life. The max score is 40 and the minimum is 8. The higher the score the worse the outcome.
measure: Pain Catastrophizing Survey Short Form 6
time frame: biweekly until week 12
description: Pain catastrophizing is a negative mental set regarding actual or anticipated pain, and includes aspects of rumination, magnification, and sense of helplessness. It will be measured using the Pain Catastrophizing scale (PCS) short form, which a 6-item questionnaire. The max score is 24 and the minimum is 0. The higher the score the worse the outcome.
measure: Patient-Reported Outcomes Measurement Information System Anxiety 4
time frame: biweekly until week 12
description: Anxiety is a commonly comorbid disease with chronic lower back pain. The PROMIS Anxiety scale will be used to assess it. This is the 4 question version of the scale. The max score is 20 and the minimum is 4. The higher the score the worse the outcome.
measure: Patient-Reported Outcomes Measurement Information System Sleep Disturbance 6a
time frame: biweekly until week 12
description: Given the impact of chronic pain on mental health there is also an impact on sleep. PROMIS Sleep Disturbance is a well-validated survey to assess sleep quality. This is version A of the 6 item scale. The max score is 30 and the minimum is 6. The higher the score the worse the outcome.
measure: Use of Opioids
time frame: The average for 30 days before Day 1 and the 30 day average at 90 day will be compared within the study.
description: In order to capture use of opioids, we will link patient electronic health record (EHR) data to the other data sources using Medical Record Numbers and date of birth. We will also request access to the CURES database for research purposes. We will convert all opioid doses into a single metric using morphine milligram equivalents (MME).
measure: Patient-Reported Outcomes Measurement Information System Physical Function 6b
time frame: biweekly basis until week 12
description: For patients with chronic pain, physical function is often diminished and patients seek return to normal function. The Patient-Reported Outcomes Measurement Information System Physical Function short-form 6b scale is a widely- validated instrument with excellent content validity, construct validity, and reliability in patients with spinal disorders and other conditions marked by diminished mobility. The instrument places patients on a continuum of function from extremely low to very high across activities that require physical actions, ranging from self-care to more complex activities that require a combination of skills. The max score is 30 and the minimum is 6. The higher the score the worse the outcome.
measure: Patient-Reported Outcomes Measurement Information System Depression 4
time frame: biweekly until week 12
description: Depression is a commonly comorbid disease with chronic lower back pain. The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scale will be used to assess it. This is the 4 item version of the scale. The max score is 20 and the minimum is 4. The higher the score the worse the outcome.
measure: Biometric data from Fitbit Charge 4 - Physical Activity
time frame: Continuously from week 1 to week 12
description: The total steps per day per day will be collected to assess physical activity.
measure: Biometric data from Fitbit Charge 4 - Sleep Quantity
time frame: Continuously from week 1 to week 12
description: The total hours of sleep per night as well as sleep efficiency will be assessed for the quantity of sleep using the Fitbit charge 4. Data will be analyzed using the Fitabase system.
arm group label: Virtual Reality Program A
arm group type: Experimental
description: This arm will include software that provides immersive skills-based content for pain reduction.
arm group label: Virtual Reality Program B
arm group type: Active Comparator
description: This arm will include software that provides immersive distraction based content for pain reduction.
arm group label: Virtual Reality Program C
arm group type: Sham Comparator
description: This arm will include software that provides nonimmersive distraction based content for pain reduction.
intervention type: Device
intervention name: PICO G2 4k
description: Participants will use the Pico G2 4K VR audio and visual head-mounted device. The Pico G2 4K is a standalone VR headset that comes with an orientation-tracked controller. It does not require a smartphone or personal computer to operate. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view.
arm group label: Virtual Reality Program A
arm group label: Virtual Reality Program B
arm group label: Virtual Reality Program C
criteria: 
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: No
last name: Brennan Spiegel, MD
role: Principal Investigator
affiliation: Cedars-Sinai
last name: Samuel Eberlein, MS
phone: 310-423-6721
email: samuel.eberlein@cshs.org
last name: Zoe Krut, MS
phone: 310-423-0699
email: zoe.krut@cshs.org
facility: 
status: Recruiting
contact: 
country: United States
url: https://virtualmedicine.org/research/current/vr4backpain
description: Study web portal for more information and a self-assessment for eligibility
responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Brennan Spiegel
investigator title: Staff Physician III
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Yes
ipd description: This study is part of the NIH Helping to End Addiction Long-term (HEAL) Initiative focused on understanding and developing new treatments for addiction and pain. Research gives us the best information and progresses more quickly when data is available from many studies and many individuals, and when many researchers can work with the data and samples and analyze them in different ways. Therefore, your data and samples will be used for this and other NIH Helping to End Addiction Long-term Initiative studies. Your stored data and samples will also be made widely available to other researchers. The shared data and samples may be used indefinitely for research not related to this study or the Helping to End Addiction Long-term (HELP) Initiative, without asking you for additional consent.
ipd time frame: 2020 to 2024
ipd access criteria: The researcher must be part of the NIH Back Pain Consortium (BACPAC) consortium.