Clinical trial NCT04415177: Virtual Reality Trial Using EaseVRx For Chronic Low Back Pain
Official title: Safety and Effectiveness of Virtual Reality Utilizing EaseVRx for the Reduction of Chronic Pain and Opioid Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Lower Back Pain
Keywords: Virtual Reality
Chronic Lower Back Pain
Analgesia
Lead sponsor: AppliedVR Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Department of Defense (DoD)/VA Pain scale
timeFrame: The primary efficacy endpoint is the change from study baseline to Day 56
Secondary outcomes:
measure: Patient's Global Impression of Change Scale
timeFrame: twice weekly during 8-week intervention, Day 56
Other outcomes:
measure: Device utilization Questionnaire
timeFrame: twice weekly during 8-week intervention, Day 56
measure: VR Satisfaction Scale
timeFrame: Day 56
measure: Custom Opioid Use Survey
timeFrame: Baseline, Day 56
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
timeFrame: Baseline, Day 56
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance
timeFrame: Baseline, Day 56
measure: Pain Self-efficacy Questionnaire
timeFrame: Baseline, Day 56
measure: Pain Catastrophizing Scale
timeFrame: Baseline, Day 56
measure: Chronic Pain Acceptance Questionnaire
timeFrame: Baseline, Day 56
measure: Behavioral Skills Assessment
timeFrame: Day 56
measure: Health Utilization Outcomes Questionnaire
timeFrame: Day 56
measure: VR Use Data
timeFrame: Day 1 through Day 56
Locations:
city: Los Angeles
country: United States
facility: AppliedVR, Inc.
state: California
Study officials:
affiliation: AppliedVR Inc.
name: Laura Garcia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia L, Birckhead B, Krishnamurthy P, Mackey I, Sackman J, Salmasi V, Louis R, Castro C, Maddox R, Maddox T, Darnall BD. Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: 6-Month Follow-up Study of a Randomized Clinical Trial. J Med Internet Res. 2022 May 25;24(5):e37480. doi: 10.2196/37480.
citation: Garcia LM, Birckhead BJ, Krishnamurthy P, Mackey I, Sackman J, Salmasi V, Louis R, Maddox T, Darnall BD. Three-Month Follow-Up Results of a Double-Blind, Randomized Placebo-Controlled Trial of 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality (VR) for Chronic Low Back Pain. J Pain. 2022 May;23(5):822-840. doi: 10.1016/j.jpain.2021.12.002. Epub 2021 Dec 11.
citation: Garcia LM, Birckhead BJ, Krishnamurthy P, Sackman J, Mackey IG, Louis RG, Salmasi V, Maddox T, Darnall BD. An 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality Program for Chronic Low Back Pain: Double-Blind, Randomized, Placebo-Controlled Trial Conducted During COVID-19. J Med Internet Res. 2021 Feb 22;23(2):e26292. doi: 10.2196/26292.
citation: Garcia LM, Darnall BD, Krishnamurthy P, Mackey IG, Sackman J, Louis RG, Maddox T, Birckhead BJ. Self-Administered Behavioral Skills-Based At-Home Virtual Reality Therapy for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jan 19;10(1):e25291. doi: 10.2196/25291.