Virtual Reality Trial Using EaseVRx For Chronic Low Back Pain

NCT04415177 | Completed

• 1 other identifier: 2020-521
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Lower Back Pain

Keywords

Virtual Reality; Chronic Lower Back Pain; Analgesia

Outcome Measures

Primary Outcomes (1)

• Department of Defense (DoD)/VA Pain scale

  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.

  The primary efficacy endpoint is the change from study baseline to Day 56

Secondary Outcomes (1)

• Patient's Global Impression of Change Scale

  twice weekly during 8-week intervention, Day 56

Other Outcomes (11)

• Device utilization Questionnaire

  twice weekly during 8-week intervention, Day 56

• VR Satisfaction Scale

  Day 56

• Custom Opioid Use Survey

  Baseline, Day 56

Study Arms (2)

VR Program A

EXPERIMENTAL

Software with active intervention

Device: EaseVRx headset with active intervention

VR Program B

ACTIVE COMPARATOR

Software without active intervention

Device: EaseVRx headset without active intervention

Interventions

EaseVRx headset with active intervention DEVICE

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

VR Program A

EaseVRx headset without active intervention DEVICE

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

VR Program B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AppliedVR Inc.: lead

Study Sites (1)

AppliedVR, Inc.

Los Angeles, California, 90067, United States

Location

Related Publications (4)

• 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.

  PMID: 35612905 DERIVED

• 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.

  PMID: 34902548 DERIVED

• 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.

  PMID: 33484240 DERIVED

• 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.

  PMID: 33464215 DERIVED

Related Links

• webpage to assess if the study is right for you

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura Garcia, PhD

  AppliedVR Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 4, 2020
• Study Start: July 1, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)