Virtual Reality Therapy for Chronic Low Back Pain

Randomized-controlled Trial of Virtual Reality for Chronic Low Back Pain to Improve Patient-reported Outcomes and Physical Activity

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Device: Distraction-Based VR; Device: Activity Tracker; Device: Sham VR; Device: Skills-Based VR

Detailed Description

This is a randomized double-blind, placebo-controlled trial for individuals with chronic lower back pain. This study investigates the effect of at-home virtual reality (VR) pain reduction therapies on a set of outcome measures. The primary outcome is Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference version 8. This study will enroll 360 analyzable participants into one of three VR therapy groups. Data collection will occur at home via personal computer or smartphone (iPhone/android), with baseline data collected one week before the intervention is mailed to the patient. Participants will have the VR headset for 90 days. Patients are also sent Fitbit smartwatches to track physical activity.

• Study Type: Interventional
• Enrollment (Actual): 413
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Samuel Eberlein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Able to provide consent to participate in research
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, age 13 or older
4. 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.
5. Ability to comprehend spoken and written English
6. Owns a compatible android or iOS smartphone, or personal laptop or desktop computer (excluding tablets) to complete surveys and has access to email.

Exclusion Criteria:

1. 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
2. Are being recommended for long-term hospitalization that would require more than three-week stay in the hospital
3. Received surgical procedure within the previous 8 weeks
4. Surgery is planned within the next 3 months
5. Is currently using a spinal cord stimulator
6. 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
7. Previously participated in a virtual reality clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Distraction-Based VR; 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; 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; Other Names: EaseVRx-Distraction Software; PICO G2 4k; Device: Activity Tracker; 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.; Other Names: Fitbit Charge 4
Sham Comparator: Sham VR; 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: Activity Tracker; 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.; Other Names: Fitbit Charge 4; Device: Sham VR; 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; Other Names: PICO G2 4k; EaseVRx-Sham Software
Experimental: Skills-Based VR; 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: Activity Tracker; 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.; Other Names: Fitbit Charge 4; Device: Skills-Based VR; 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; Other Names: PICO G2 4k; EaseVRx+ Software

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 60 and Day 90	One of the secondary outcomes for this study will be self-reported pain interference (PI) 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 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 60 - baseline and Day 90 - baseline, therefore a negative difference corresponds to improvement of symptoms (reduced PI)	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.	The outcome for this study will be self-reported pain catastrophizing using the Pain Catastrophizing Survey Short Form 6 (PCS SF-6). Pain catastrophizing is a negative mental set regarding actual or anticipated pain, and includes aspects of rumination, magnification, and sense of helplessness. PCS is a 6-item short form survey that measures rates of high catastrophizing as defined by a score of ≥7. Items are rated on a 5-point Likert scale from "not at all" (0) to "all the time" (4) with a raw score calculated by a sum of the 6 items ranging from 0 to 24. The scale is positively scored, where higher scores indicate greater levels of pain catastrophizing. The difference from baseline is reported as Day 90 - baseline, therefore a negative difference corresponds to improvement of symptoms (reduced pain catastrophizing).	From baseline to end of treatment at day 90
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Day 90	The primary outcome for this study will be self-reported anxiety using Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety version 4. This scale assesses self-reported perceptions of fear, anxious misery (worry, dread), hyperarousal, and somatic symptoms related to arousal. Items are rated Items are rated on a 5-point Likert scale from "never" (1) to "always" (5), with a raw score calculated by a sum of the 4 items ranging from 4 to 20. 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-Anxiety is positively scored, where higher scores indicate worse anxiety. The difference from baseline is reported as Day 90 - baseline, therefore a negative difference corresponds to improvement of symptoms (reduced anxiety).	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	The secondary outcome for this study will be self-reported Sleep Disturbance using Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance version 6a. This scale assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Items are rated on a 5-point Likert scale from "not at all" (1) and "very much" (5), with a raw score calculated by a sum of the 6 items ranging from 6 to 30. 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-Sleep Disturbance is positively scored, where higher scores indicate worse sleep disturbance. The negative difference from baseline corresponds to improvement of symptoms (reduced sleep disturbance).	From baseline to end of treatment at day 90
Change From Baseline to Day 90 in Weekly Average Opioid Usage	The secondary outcome for the this study is the change from study baseline to Day 90 in the frequency of self-reported daily opioid use. Participants were asked at baseline and Day 90 "Are you currently taking an opioid pain medication on a daily basis? Yes, No, or Not sure" The number of "Yes" responses and the total number of responses is reported.	From baseline to end of treatment at day 90

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 6b at Day 90	The exploratory outcome for this study will be self-reported physical function using Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 6b. The 6-item PROMIS Physical Function scale measures measures self-reported functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living. Items are rated on a 5-point Likert scale from "Cannot do" (1) to "Not at all" (5), with a raw score calculated by a sum of the 6 items ranging from 6 to 30.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-Physical Function is positively scored, where higher T-scores indicate better physical function. The difference from baseline is reported as Day 90 - baseline, with positive differences indicating better physical function.	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	The exploratory outcome for this study will be self-reported depression using Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 4 scale. The 4-item PROMIS Depression scale measures self-reported negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Items are rated on a 5-point Likert scale from "never" (1) to "always" (5), with a raw score calculated by a sum of the 4 items ranging from 4 to 20. 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 more severe depression. The negative difference from baseline corresponds to improvement of symptoms (reduced depression symptoms).	From baseline to end of treatment at day 90
Biometric Data From Fitbit Charge 4 - Change in Average Daily Steps	The change in average daily steps, as measured by FitBit, is an exploratory endpoint to measure the change in daily physical activity of study participants throughout the duration of study participation. For example, higher number of steps across individuals may indicate greater physical activity, and increasing number of steps throughout the study may indicate improving physical activity. Data from Fitbit devices were aggregated by Fitabase during a designated window of enrollment. Daily steps were averaged over 7-day periods account for variation in Fitbit adherence, i.e. wearing the device. The average of daily steps taken over the first week of study participation is used as the baseline measurement because Fitbit devices were provisioned to participants after baseline measurements were recorded (e.g. start of treatment). Similarly, an average of daily steps recorded over the final seven days of treatment (to day 90) were measured.	From day 1 to end of treatment at day 90
Biometric Data From Fitbit Charge 4 - Change in Average Sleep Score	The change in average sleep score, as measured by FitBit, is an exploratory endpoint to measure the change of sleep quality throughout the duration of study participation. A higher change in sleep score may indicate improvement in the quality of sleep. Fitbit calculates sleep score using an algorithm which takes into account heart rate, total time asleep, and stages of sleep. Sleep scores range from 0-100, with the following categories: Excellent: 90-100 Good: 80-89 Fair: 60-79 Poor: Less than 60 The average score ranges from 72 to 83. Data from Fitbit devices were aggregated by Fitabase during a designated window of enrollment. Sleep scores were averaged over 7-day periods account for variation in Fitbit adherence, i.e. wearing the device. The average of sleep scores recorded over the first week of study participation is used as the baseline. Similarly, an average of sleep scores recorded over the final seven days of treatment (to day 90) was measured.	From day 1 to end of treatment at day 90
Change in Overall Effect of Treatment From Baseline to Day 90 Measured by Patient's Global Impression of Change (PGIC)	The overall effect of the treatment from study baseline to Day 90, measured by the Patients' Global Impression of Change (PGIC) is an exploratory endpoint to assess the efficacy of Skills-based and Distraction VR. This scale measures self-reported belief regarding efficacy of treatment. At Day 90, participants are asked "Since the start of the study, my overall pain is..." with responses on a 7-point Likert scale from "Very much improved" (1) to "Very much worse" (7). Based on the PGIC assessment, a dichotomous scale of "Yes" or "No" was derived. A favorable response of 1-4 on the PGIC indicates "Yes, significant improvement occurred over the course of the study". An unfavorable response of 5-7 indicates "No, significant improvement did not occur over the course of the study". Number of participants who scored between 1-4, therefore indicating a significant improvement in their pain levels over the course of the study ("Number of participants with "Yes"), are reported below.	Measured at end of treatment at day 90

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Brennan Spiegel, MD, Cedars-Sinai

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Actual): October 17, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Estimated): October 31, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Analgesia; Virtual Reality; Chronic Low Back Pain
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Equipment and Supplies; Electrical Equipment and Supplies; Diagnostic Equipment; Wearable Electronic Devices; Fitness Trackers
• Other Study ID Numbers: Pro00000631; 1UG3AR076573-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This study is part of the NIH Helping to End Addiction Long-term (HEAL) Initiative focused on understanding and developing new treatments for addiction and pain. Deidentified patient data, including demographics and longitudinal patient reported outcomes (PROs) are uploaded to the Back Pain Consortium (BACPAC) Data Portal.
• IPD Sharing Time Frame: 2020 to 2024
• IPD Sharing Access Criteria: The researcher must be part of the NIH Back Pain Consortium (BACPAC) consortium.

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: p2cs-sdtm

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes