Virtual Reality Trial Using EaseVRx For Chronic Low Back Pain

AppliedVR

Status: Completed

Conditions: Chronic Lower Back Pain

Treatments: Device: EaseVRx headset without active intervention; Device: EaseVRx headset with active intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT04415177

2020-521

Details and patient eligibility

About

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.

Full 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.

Enrollment: 188 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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188 participants in 2 patient groups

VR Program A

Experimental group

Description:

Software with active intervention

Treatment:

Device: EaseVRx headset with active intervention

VR Program B

Active Comparator group

Description:

Software without active intervention

Treatment:

Device: EaseVRx headset without active intervention