Status:
COMPLETED
Virtual Reality Trial Using EaseVRx For Chronic Low Back Pain
Lead Sponsor:
AppliedVR Inc.
Conditions:
Chronic Lower Back Pain
Eligibility:
All Genders
18-85 years
Phase:
NA
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 progra...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT04415177
Start Date
July 1 2020
End Date
April 30 2021
Last Update
January 11 2022
Active Locations (1)
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1
AppliedVR, Inc.
Los Angeles, California, United States, 90067