Virtual Reality Therapy for Chronic Low Back Pain

NCT04409353 | Completed Results DMC FDA Device

• 2 other identifiers: Pro000006311UG3AR076573-01
• Study Type: interventional
• Target: 413
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the efficacy of an evidence-based virtual reality (VR) therapy program as a non-pharmacological supplement for the management of chronic lower back pain. Study participants will be randomized to receive one of three VR programs: Skills-Based VR, Distraction VR, or Sham VR. In addition to a VR headset, all participants will receive a Fitbit Charge 4 watch. Study devices will be delivered to the participant's home with instructions for use via FedEx; participants will receive remote technical support. They will be followed for 90 days and complete Patient Reported Outcome (PRO) questionnaires to assess functional status, pain levels, and use of pain medications (including opioids). Participants will also be asked to provide consent/authorization to access medical records from their treating facility.

Conditions

Chronic Low Back Pain

Keywords

Virtual Reality; Chronic Low Back Pain; Analgesia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 30

  The primary outcome for this study will be self-reported pain interference using Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) version 8a. The pain interference scale measures the consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Items are rated on a 5-point Likert scale from "not at all" (1) to "very much" (5) with a raw score calculated by a sum of the 8 items ranging from 8 to 40. Results are linked to a T-Score (healthmeasures.net) to standardize the results across a general population (a mean T-score of 50 and a standard deviation of 10). PROMIS-PI is positively scored, where higher scores indicate worse pain interference. The difference from baseline is reported as Day 30 - baseline, therefore a negative difference corresponds to improvement of symptoms (reduced pain interference).

  From baseline to day 30

Secondary Outcomes (5)

• Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 60 and Day 90

  From baseline to day 60, from baseline to end of treatment at day 90

• Change From Baseline in Pain Catastrophizing Survey Short Form 6 (PCS SF-6) at Day 90.

  From baseline to end of treatment at day 90

• Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Day 90

  From baseline to end of treatment at day 90

• Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance to Day 90

  From baseline to end of treatment at day 90

• Change From Baseline to Day 90 in Weekly Average Opioid Usage

  From baseline to end of treatment at day 90

Other Outcomes (5)

• Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 6b at Day 90

  From baseline to end of treatment at day 90

• Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 4 at Day 90

  From baseline to end of treatment at day 90

• Biometric Data From Fitbit Charge 4 - Change in Average Daily Steps

  From day 1 to end of treatment at day 90

Study Arms (3)

Distraction-Based VR

ACTIVE COMPARATOR

EaseVRx-Distraction has the same number of experiences, the same approximate duration of experiences, and the identical user interface as EaseVRx+, with a linear prescribed sequence of experiences. The key differences are the lack of an on-demand library and that instead of offering a variety of VR experiences including education, games, and breath biofeedback, EaseVRx Distraction only includes 360-degree videos - which are also present in EaseVRx+. This is intended to remove the effect of education and skills-based training, while preserving the immersive experience of 360- degree VR.

Device: Distraction-Based VR; Device: Activity Tracker

Sham VR

SHAM COMPARATOR

EaseVRx-Sham software includes 2D nature footage accompanied by neutral music that is selected to be neither relaxing nor distracting, rather than 360-degree, 3D, interactive content specially selected for efficacy. The experience of using EaseVRx-Sham is similar to watching a large-screen TV, but it is not interactive or immersive. EaseVRx Sham has the same number and duration of experiences as the EaseVRx+ linear prescribed sequence but does not contain an on-demand library; the functionality of the user interface used to access the experiences is otherwise the same as EaseVRx+. Modifications were made to the appearance of the user interface in order to remove aspects that were added for therapeutic benefit.

Device: Sham VR; Device: Activity Tracker

Skills-Based VR

EXPERIMENTAL

EaseVRx+ incorporates the evidence-based principles of CBT, mindful meditation, and physiologic biofeedback therapy using embedded biometric sensors. It combines psychoeducation, pain education, breathing training, relaxation exercises, and executive functioning games to provide a mind-body approach toward living better with chronic pain. The standardized, prescriptive, and reproducible 56-day program delivers a combination of skills training and CBT-related treatments through scheduled daily virtual experiences. EaseVRx+ also features an on-demand library, allowing users to access any of the unique video sessions as needed.

Device: Skills-Based VR; Device: Activity Tracker

Interventions

Distraction-Based VR DEVICE

Participants will use the Pico G2 4K VR audio and visual head-mounted device, loaded with the EaseVRx-Distraction software. The Pico G2 4K is a standalone VR headset that comes with an orientation-tracked controller. It does not require a smartphone or personal computer to operate. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view. The headset battery requires recharging after approximately 2.5 hours of use. https://www.pico-interactive.com/us/G2\_4K.html

Also known as: EaseVRx-Distraction Software, PICO G2 4k

Distraction-Based VR

Sham VR DEVICE

Participants will use the Pico G2 4K VR audio and visual head-mounted device, loaded with the EaseVRx-Sham software. The Pico G2 4K is a standalone VR headset that comes with an orientation-tracked controller. It does not require a smartphone or personal computer to operate. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view. The headset battery requires recharging after approximately 2.5 hours of use. https://www.pico-interactive.com/us/G2\_4K.html

Also known as: EaseVRx-Sham Software, PICO G2 4k

Sham VR

Skills-Based VR DEVICE

Participants will use the Pico G2 4K VR audio and visual head-mounted device, loaded with the EaseVRx+ software. The Pico G2 4K is a standalone VR headset that comes with an orientation-tracked controller. It does not require a smartphone or personal computer to operate. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view. The headset battery requires recharging after approximately 2.5 hours of use. https://www.pico-interactive.com/us/G2\_4K.html

Also known as: EaseVRx+ Software, PICO G2 4k

Skills-Based VR

Activity Tracker DEVICE

Participants among all arms will be provided the option to passively wear a Fitbit Charge 4 throughout their 90-day study enrollment period. The Fitbit collects biometric data such as daily steps, heart rate, hours of sleep, stages of sleep, and sleep efficiency.

Also known as: Fitbit Charge 4

Distraction-Based VR; Sham VR; Skills-Based VR

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide consent to participate in research
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, age 13 or older
• An ongoing low back-pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months.
• Ability to comprehend spoken and written English
• Owns a compatible android or iOS smartphone, or personal laptop or desktop computer (excluding tablets) to complete surveys and has access to email.

You may not qualify if:

• Presents with a condition that interferes with virtual reality usage, including history of seizure, facial injury precluding safe placement of headset, significant visual or hearing impairment that impacts ability to see the virtual reality images or follow audio instructions
• Are being recommended for long-term hospitalization that would require more than three-week stay in the hospital
• Received surgical procedure within the previous 8 weeks
• Surgery is planned within the next 3 months
• Is currently using a spinal cord stimulator
• Has low back pain attributable to a recognizable, specific pathology, including spinal infection, cancer, fracture, or inflammatory spondylopathies, consistent with the NIH Task force on Research Standards for chronic low back pain
• Previously participated in a virtual reality clinical trial

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Samuel Eberlein

Los Angeles, California, 90048, United States

Location

Related Publications (1)

• Birckhead B, Eberlein S, Alvarez G, Gale R, Dupuy T, Makaroff K, Fuller G, Liu X, Yu KS, Black JT, Ishimori M, Venuturupalli S, Tu J, Norris T, Tighiouart M, Ross L, McKelvey K, Vrahas M, Danovitch I, Spiegel B. Home-based virtual reality for chronic pain: protocol for an NIH-supported randomised-controlled trial. BMJ Open. 2021 Jun 15;11(6):e050545. doi: 10.1136/bmjopen-2021-050545.

  PMID: 34130965 DERIVED

Related Links

• Study web portal for more information and a self-assessment for eligibility

MeSH Terms

Conditions

Agnosia

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Limitations and Caveats

Survey responses contained 2-week response windows, so responses at a point in time do not necessarily reflect the actual difference in days. Variation exists in day difference between baseline measurements and start of study intervention due to variation and delays in the shipping of study devices to participants' homes and the availability of participants to complete protocolized onboarding phone calls. Only 5 of the 7 baseline daily pain scores were required to be randomized into the study.

Results Point of Contact

• Title: Samuel Eberlein
• Organization: Cedars-Sinai Medical Center

samuel.eberlein@cshs.org

310-423-6721

Study Officials

• Brennan Spiegel, MD

  Cedars-Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, Providers, Primary Investigator, and Biostatistician were all blinded to allocations until the end of data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician III

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: June 1, 2020
• Study Start: September 21, 2020
• Primary Completion: October 17, 2023
• Study Completion: February 1, 2024
• Last Updated: October 31, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: 2020 to 2024
• Access Criteria: The researcher must be part of the NIH Back Pain Consortium (BACPAC) consortium.

Locations

US (1)