Virtual Reality Trial Using EaseVRx For Chronic Low Back Pain

Not Applicable

Completed

• Conditions: Chronic Lower Back Pain
• Interventions: Device: EaseVRx headset without active intervention; Device: EaseVRx headset with active intervention

• Registration Number: NCT04415177
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-04
• Study Start: 2020-07-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-07
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR Program B	EaseVRx headset without active intervention	Software without active intervention
VR Program A	EaseVRx headset with active intervention	Software with active intervention

Primary Outcome Measures

Name	Time	Method
Department of Defense (DoD)/VA Pain scale	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

Name	Time	Method
Patient's Global Impression of Change Scale	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.

Trial Locations

Locations (1)

AppliedVR, Inc.; 🇺🇸 Los Angeles, California, United States