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Virtual Reality Trial Using EaseVRx For Chronic Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04415177
Recruitment Status : Completed
First Posted : June 4, 2020
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
AppliedVR Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Lower Back Pain Device: EaseVRx headset with active intervention Device: EaseVRx headset without active intervention Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of Virtual Reality Utilizing EaseVRx for the Reduction of Chronic Pain and Opioid Use
Actual Study Start Date : July 1, 2020
Actual Primary Completion Date : April 30, 2021
Actual Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: VR Program A
Software with active intervention
Device: EaseVRx headset with active intervention
VR software developed by AppliedVR informed by evidence-based cognitive behavioral therapy principles, biofeedback and mindfulness strategies for pain management.

Active Comparator: VR Program B
Software without active intervention
Device: EaseVRx headset without active intervention
VR software developed by AppliedVR with neutral non-interactive content.




Primary Outcome Measures :
  1. Department of Defense (DoD)/VA Pain scale [ Time Frame: The primary efficacy endpoint is the change from study baseline to Day 56 ]
    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.


Secondary Outcome Measures :
  1. Patient's Global Impression of Change Scale [ Time Frame: twice weekly during 8-week intervention, Day 56 ]
    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.


Other Outcome Measures:
  1. Device utilization Questionnaire [ Time Frame: twice weekly during 8-week intervention, Day 56 ]
    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.

  2. VR Satisfaction Scale [ Time Frame: Day 56 ]
    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.

  3. Custom Opioid Use Survey [ Time Frame: Baseline, Day 56 ]
    Custom survey assesses the use of opioids, frequency of use, dose of medication, happiness with regimen, and interest in change in treatment.

  4. Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function [ Time Frame: Baseline, Day 56 ]
    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.

  5. Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance [ Time Frame: Baseline, Day 56 ]
    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.

  6. Pain Self-efficacy Questionnaire [ Time Frame: Baseline, Day 56 ]
    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.

  7. Pain Catastrophizing Scale [ Time Frame: Baseline, Day 56 ]
    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.

  8. Chronic Pain Acceptance Questionnaire [ Time Frame: Baseline, Day 56 ]
    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.

  9. Behavioral Skills Assessment [ Time Frame: Day 56 ]
    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.

  10. Health Utilization Outcomes Questionnaire [ Time Frame: Day 56 ]
    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.

  11. VR Use Data [ Time Frame: Day 1 through Day 56 ]
    VR use calculated as the total number of sessions launched. It will be continuous data stored on the headset.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women 18-85 years old
  • Diagnosis of low back pain without radicular symptoms
  • Pain duration of at least 6 months
  • Average pain intensity of at least 4 on the 0-10 DoD/VA Pain Scale for the past month at screening
  • English fluency
  • Willing to comply with study procedures/restrictions

Exclusion Criteria:

  • Unable to understand the goals of the study due to cognitive difficulty
  • Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines or other neurological disease that may prevent the use of VR
  • Medical condition predisposing to nausea or dizziness
  • Hypersensitivity to flashing light or motion
  • No stereoscopic vision or severe hearing impairment
  • Injury to eyes, face or neck that prevents comfortable use of VR
  • Pain related to cancer
  • Active suicidal ideation or severe depression
  • Previous use of EaseVR for pain
  • Current participation in any interventional research study or completed participation in past 2 months
  • Currently pregnant or planning to become pregnant
  • Does not have access to WIFI during participation in study
  • Currently works at or has an immediate family member who works for a digital health company or pharmaceutical company that provides treatments for acute or chronic pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04415177


Locations
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United States, California
AppliedVR, Inc.
Los Angeles, California, United States, 90067
Sponsors and Collaborators
AppliedVR Inc.
Investigators
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Principal Investigator: Laura Garcia, PhD AppliedVR Inc.
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AppliedVR Inc.
ClinicalTrials.gov Identifier: NCT04415177    
Other Study ID Numbers: 2020-521
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AppliedVR Inc.:
Virtual Reality
Chronic Lower Back Pain
Analgesia
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations