EaseVRx-8w+ for the Treatment of Chronic Lower Back Pain

NCT05263037 | Active Not Recruiting Results FDA Device

• 1 other identifier: EaseVRx HEOR 2021
• Study Type: interventional
• Target: 1,093
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized controlled trial (RCT) is to assess outcomes for virtual reality therapy (including pain intensity, pain interference, anxiety, depression, physical function, sleep, behavioral skills development, health outcomes and satisfaction) along with healthcare utilization and costs in participants with Chronic Low Back Pain.

Conditions

Chronic Low-back Pain; Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory (BPI) Pain Intensity Questionnaire

  The BPI pain intensity questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The range of scores are from 0-10 with higher values implying greater pain intensity. The BPI pain intensity measure contains a single item related to pain intensity

  Day 56 (end of treatment)

Secondary Outcomes (4)

• Oswestry Disability Index Score (ODI v2.1b)

  The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment. Anticipated reporting date June 2027

• PROMIS Sleep Disturbance

  The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment

• PROMIS Depression

  The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment

• PROMIS Anxiety

  The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment

Study Arms (4)

56-day skills-based VR program

EXPERIMENTAL

participants in the EaseVRx-8w arm will participate in an 8-week interventional program and continue to be followed for 24 months following completion of tx

Device: EaseVRx

56-day skills-based VR program followed by an extended 56-day on-demand period

EXPERIMENTAL

participants in the EaseVRx-8w plus extended on-demand arm will enroll in an 8-week interventional program and be offered an extended 8-week ondemand period, and continue to be followed for 24 months after the completion of treatment

Device: EaseVRx

56-day control (Sham VR)

SHAM COMPARATOR

participants in the first control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and continue to be followed for 24 months after the completion of treatment. participants in the Sham VR group will receive the same Pico G2 4K headset as participants in the immersive VR groups, but rather than view 360-degree, 3D, interactive content specially selected for efficacy, they will only have access to 2D nature footage with neutral music layered on top that is selected to be neither overly relaxing nor distracting. The experience of Sham VR is similar to watching a large-screen TV, but it is not interactive. The advantage of Sham VR is that it controls for the novelty and immersion of the hardware and isolates the effect of VR skill-based training

Device: Sham VR

• 56-day control (Sham VR plus 8w extended on-demand)

SHAM COMPARATOR

participants in the second control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and be offered an extended 8-week on-demand period, after which they will continue to be followed for 24 months after the completion of treatment.Participants in the Sham VR group will receive the same Pico G2 4K headset as participants in the immersive VR groups, but rather than view 360-degree, 3D, interactive content specially selected for efficacy, they will only have access to 2D nature footage with neutral music layered on top that is selected to be neither overly relaxing nor distracting.

Device: Sham VR

Interventions

EaseVRx DEVICE

VR software with interactive content

Also known as: Skills based EaseVR

56-day skills-based VR program; 56-day skills-based VR program followed by an extended 56-day on-demand period

Sham VR DEVICE

VR with neutral non-interactive content

56-day control (Sham VR); • 56-day control (Sham VR plus 8w extended on-demand)

Eligibility Criteria

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

You may qualify if:

• Male and female adults aged 18-85.
• Self-reported chronic low back pain that will be confirmed with claims data when available.
• Pain duration of at least three months.
• Average pain intensity score of ≥ 4 and average pain interference score of ≥ 4 on the 0-10 Brief Pain Inventory (BPI) Pain Scale for the past month at screening.
• Fluency in English.
• Willing and able to comply with all study procedures including all required restrictions for the duration of study participation.
• Able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study.
• Access to Internet for the duration of their study participation (24 months).
• Access to a smartphone or computer for the duration of the study.
• Availability of a physical mailing address that is not a PO box address for receipt of the device.
• Completed the Baseline Survey plus at least two of the five sets of participant surveys that are administered during the 10-day pretreatment assessment period.
• Able to provide photo ID

You may not qualify if:

• Unable to understand the goals of the study due to cognitive difficulty.
• Any medical condition that may prevent the use of virtual reality (e.g., current, or prior diagnosis of epilepsy, seizure disorder, hypersensitivity to flashing light or motion, migraines, any medical condition predisposing participant to nausea or dizziness, dementia, absence of stereoscopic vision or severe hearing impairment).
• Injury to eyes, face, or neck that prevents comfortable use of VR.
• Index back pain is linked to a cancer-related diagnosis.
• Possible suicidal ideation as indicated by the 9th item of the Participant Health Questionnaire-9 (PHQ-9).
• Previous participation in the 2020 AVR EaseVRx pivotal study.
• Receiving worker's compensation and/or involved in any active litigation related to an injury.
• Current or recent participation (i.e., within the last 2 months) in any other research study involving a drug, device, vaccine, or other interventional treatment product; or plans to participate in another research study over the next 24 months.
• Participation of two or more members in one household
• Recent or future medical procedures scheduled related to any current diagnosis

Sponsors & Collaborators

• AppliedVR Inc.: lead

Study Sites (1)

AppliedVR

Van Nuys, California, 91406, United States

Location

Related Publications (3)

• Maddox T, Sackman J, Judge E, Maddox R, Bonakdar R, Darnall BD. From randomized controlled trial to real world clinical evidence: effectiveness and engagement of in-home virtual reality pain treatment for chronic pain in older adults. Front Pain Res (Lausanne). 2025 Dec 10;6:1694007. doi: 10.3389/fpain.2025.1694007. eCollection 2025.

  PMID: 41450975 DERIVED

• Maddox T, Oldstone L, Linde-Zwirble W, Bonakdar R, Maddox R, Sackman J, Adair T, Ffrench K, Sparks C, Darnall BD. Differential treatment response to virtual reality in high-impact chronic pain: secondary analysis of a randomized trial. Sci Rep. 2025 Apr 25;15(1):14430. doi: 10.1038/s41598-025-98716-3.

  PMID: 40281004 DERIVED

• Maddox T, Oldstone L, Sparks CY, Sackman J, Oyao A, Garcia L, Maddox RU, Ffrench K, Garcia H, Adair T, Irvin A, Maislin D, Keenan B, Bonakdar R, Darnall BD. In-Home Virtual Reality Program for Chronic Lower Back Pain: A Randomized Sham-Controlled Effectiveness Trial in a Clinically Severe and Diverse Sample. Mayo Clin Proc Digit Health. 2023 Oct 24;1(4):563-573. doi: 10.1016/j.mcpdig.2023.09.003. eCollection 2023 Dec.

  PMID: 40206316 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Vice President of Research
• Organization: AppliedVR

tmaddox@appliedvr.io

13108901584

Study Officials

• Todd Maddox, Ph.D.

  AppliedVR Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, study statisticians and investigators will be blinded to treatment group assignment until after the last subject contributes their primary outcome at week 16. Prior to the primary analysis, the database will be officially locked and signed off by the Sponsor and key stakeholders. Study participants will remain blinded to treatment group assignment until study completion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: VP of Research

Model Details: Enrolled participants will be randomized 1:1:1:1 and assigned to one of four treatment arms: * 56-day skills-based VR program (EaseVRx-8w) * 56-day skills-based VR program followed by an extended 56-day on-demand period (EaseVRx-8w plus extended on-demand) * 56-day control (Sham VR) * 56-day control followed by an extended 56-day on-demand period (Sham VR plus 8w extended on-demand)

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: March 2, 2022
• Study Start: January 31, 2022
• Primary Completion: October 13, 2022
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 29, 2025
• Results First Posted: December 20, 2023

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)