Virtual Reality Trial Using EaseVRx For Chronic Low Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Lower Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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VR Program A

Software with active intervention

Group Type EXPERIMENTAL

EaseVRx headset with active intervention

Intervention Type DEVICE

VR software developed by AppliedVR informed by evidence-based cognitive behavioral therapy principles, biofeedback and mindfulness strategies for pain management.

VR Program B

Software without active intervention

Group Type ACTIVE_COMPARATOR

EaseVRx headset without active intervention

Intervention Type DEVICE

VR software developed by AppliedVR with neutral non-interactive content.

Interventions

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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.

Intervention Type DEVICE

EaseVRx headset without active intervention

VR software developed by AppliedVR with neutral non-interactive content.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No