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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3AR076573-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brennan Spiegel, MD | Cedars-Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samuel Eberlein | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34130965 | Derived | 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. |
| Label | URL |
|---|---|
| Study web portal for more information and a self-assessment for eligibility | View source |
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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.
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2020 to 2024
The researcher must be part of the NIH Back Pain Consortium (BACPAC) consortium.
Of 1,213 screened participants, 413 met inclusion criteria and signed an eConsent form. Of these, only 385 successfully completed the minimum required 4 of 7 screening week surveys and were randomized to treatment.
Participants were recruited from Cedars-Sinai physician partners at outpatient pain clinic, spine center, rheumatology, community partners such as the ACPA and Saban Clinic, and/or pulled directly from the medical record database between September 2020 and October 2023. All enrollment activities were conducted remotely, by telephone and electronic survey. Recruitment spanned from 10/21/2020 to 10/17/2023. 385 total participants were recruited, producing a final analyzable sample N=360.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 difference is 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. 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 Activity Tracker: Participants among all arms were given the option to passively wear a Fitbit Charge 4 throughout their 90-day study enrollment period. The Fitbit collected biometric data such as daily steps, heart rate, hours of sleep, stages of sleep, and sleep efficiency. |
| FG001 | 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 EaseVRx, and the functionality of the user interface used to access the experiences is the same. Modifications were made to the appearance of the user interface in order to remove aspects that were added for therapeutic benefit. 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 Activity Tracker: Participants among all arms were given the option to passively wear a Fitbit Charge 4 throughout their 90-day study enrollment period. The Fitbit collected biometric data such as daily steps, heart rate, hours of sleep, stages of sleep, and sleep efficiency. |
| FG002 | 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. 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 Activity Tracker: Participants among all arms were given the option to passively wear a Fitbit Charge 4 throughout their 90-day study enrollment period. The Fitbit collected biometric data such as daily steps, heart rate, hours of sleep, stages of sleep, and sleep efficiency. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 difference is 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. 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 Activity Tracker: Participants among all arms were given the option to passively wear a Fitbit Charge 4 throughout their 90-day study enrollment period. The Fitbit collected biometric data such as daily steps, heart rate, hours of sleep, stages of sleep, and sleep efficiency. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All analyses will be performed by study arm using an Intent-to-Treat (ITT) population defined as all randomized participants across all three arms. Missing data was accounted for in the overall number of participants analyzed. | Posted | Mean | Standard Deviation | units on a scale | From baseline to day 30 |
Adverse event data were collected during participants' 12-week follow-up period.
Adverse events were collected primarily by a weekly adverse event assessment questionnaire, and events were also reported if participants indicated an adverse event during communications with study team and via other study free-text responses.
Adverse events were considered moderate if medical intervention, such as use of a medication or an outpatient visit to a medical professional, occurred. Events were considered severe if visits with medical professionals involved an overnight stay.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 difference is 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. 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 Activity Tracker: Participants among all arms were given the option to passively wear a Fitbit Charge 4 throughout their 90-day study enrollment period. The Fitbit collected biometric data such as daily steps, heart rate, hours of sleep, stages of sleep, and sleep efficiency. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment | Inpatient hospitalization for cholelithiasis from 12/30/2022 to 1/8/2023 that was unrelated to the intervention. The event was deemed severe, unexpected and was resolved with treatment. The participant discontinued use of the intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial Injury Aggravation | Injury, poisoning and procedural complications | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samuel Eberlein | Cedars-Sinai Medical Center | 310-423-6721 | samuel.eberlein@cshs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 19, 2023 | Oct 24, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 14, 2021 | Jan 22, 2025 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 27, 2022 | Nov 6, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000072936 | Fitness Trackers |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
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Participants, Providers, Primary Investigator, and Biostatistician were all blinded to allocations until the end of data collection.
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| 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. |
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| 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. |
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| 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. |
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| 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 |
| 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 |
| Major surgery during participation window |
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| Life event occurred during participation window |
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| Lack of Efficacy |
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| Adverse Event |
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| Disease burden - unable to participate |
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| Intervention too complicated |
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| BG001 | 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 EaseVRx, and the functionality of the user interface used to access the experiences is the same. Modifications were made to the appearance of the user interface in order to remove aspects that were added for therapeutic benefit. 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 Activity Tracker: Participants among all arms were given the option to passively wear a Fitbit Charge 4 throughout their 90-day study enrollment period. The Fitbit collected biometric data such as daily steps, heart rate, hours of sleep, stages of sleep, and sleep efficiency. |
| BG002 | 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. 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 Activity Tracker: Participants among all arms were given the option to passively wear a Fitbit Charge 4 throughout their 90-day study enrollment period. The Fitbit collected biometric data such as daily steps, heart rate, hours of sleep, stages of sleep, and sleep efficiency. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Employment | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Income | Count of Participants | Participants |
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| Average of daily back pain assessments | Baseline measure refers to the average of daily assessments for self-reported back pain on an 11-point scale from 0 (No Pain) to 10 (Pain as bad as you can imagine) over a 7-day screener week for 385 participants. Participants were asked to report their pain scores each day for the. Each participant provided at least 4 of the 7 assessments to qualify for the study. The average of all available measurements for each participant was computed, then averages of averages were computed by arm. Higher scores indicate worse pain. | Mean | Standard Deviation | units on a scale |
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| Average low-back pain in past 7 days | Baseline measure refers to the average self-reported back pain on an 11-point scale from 0 (No Pain) to 10 (Pain as bad as you can imagine) for 385 participants. Participants were asked to recall and report their average back pain in the past 7 days during a single measurement during the 7-day screener week. Averages were computed by arm. Higher scores indicate worse pain. | Mean | Standard Deviation | units on a scale |
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| Opioid Use | Measure of the number of participants who self-report opioid use at the start of the trial, collected during 7-day screener week prior to randomization. | Count of Participants | Participants |
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| Back Pain Severity | Measure of the number of participants who self-reported that their lower back pain was more severe than pain in other parts of their body. Collected during 7-day screener week prior to randomization. | Count of Participants | Participants |
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| Back Pain Operation | Measure of the number of participants who self-reported their previous surgical history for their lower back. Collected during 7-day screener week prior to randomization. | Count of Participants | Participants |
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| Chronic Pain | Participants were asked to affirm or deny chronic pain in different locations of the body (head or face, right hand arm or shoulder, left hand arm or shoulder, right buttock leg or foot, left buttock leg or foot, chest abdomen or pelvis, neck or upper back). These values were combined to determine a total raw score for Chronic Pain. Raw scores range from 0-6, with higher scores indicating chronic pain that's spread out compared to low scores that indicate localized pain. | Mean | Standard Deviation | units on a scale |
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| ITQ score | The Immersive Tendency Questionnaire is scored by using a scale of 1 (never) to 7 (often) to answer 18 questions that assesses a person's emotional engagement, how often they use digital devices, and how much attention they give to an activity to the point of neglecting their surroundings. Scores can range from 18-126 - higher scores indicate that a person's sense of immersion is intense. ITQ is asked once during the screening week. | Mean | Standard Deviation | units on a scale |
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| Patient Health Questionnaire-2 (PHQ-2) | PHQ-2 is a two-question screening tool that measures the likelihood of depression. Respondents rate how often they have experienced depressed mood or anhedonia (lack of pleasure in activities) over the past two weeks. Responses to each question are recorded on a Likert scale from 0 to 3, with 0 indicating "not at all" and 3 indicating "nearly every day". A score of 3 or higher indicates a likelihood of major depressive disorder. The total score is the sum of the two responses, ranging from 0 to 6. Questionnaire was sent to participants once during 7-day screening week. | Mean | Standard Deviation | units on a scale |
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| Secondary | 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) | All analyses will be performed by study arm using an Intent-to-Treat (ITT) population defined as all randomized participants across all three arms. Missing data was accounted for in the overall number of participants analyzed. | Posted | Mean | Standard Deviation | units on a scale | From baseline to day 60, from baseline to end of treatment at day 90 |
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| Secondary | 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). | All analyses will be performed by study arm using an Intent-to-Treat (ITT) population defined as all randomized participants. Missing data was accounted for in the overall number of participants analyzed. | Posted | Mean | Standard Deviation | units on a scale | From baseline to end of treatment at day 90 |
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| Secondary | 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). | All analyses will be performed by study arm using an Intent-to-Treat (ITT) population defined as all randomized participants across all three arms. Missing data was accounted for in the overall number of participants analyzed. | Posted | Mean | Standard Deviation | units on a scale | From baseline to end of treatment at day 90 |
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| Secondary | 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). | All analyses will be performed by study arm using an Intent-to-Treat (ITT) population defined as all randomized participants across all three arms. Missing data was accounted for in the overall number of participants analyzed. | Posted | Mean | Standard Deviation | units on a scale | From baseline to end of treatment at day 90 |
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| Secondary | 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. | Responses marked as "Not sure" or missing were excluded from the number analyzed. | Posted | Count of Participants | Participants | From baseline to end of treatment at day 90 |
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| Other Pre-specified | 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. | All analyses will be performed by study arm using an Intent-to-Treat (ITT) population defined as all randomized participants across all three arms. Missing data was accounted for in the overall number of participants analyzed. | Posted | Mean | Standard Deviation | units on a scale | From baseline to end of treatment at day 90 |
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| Other Pre-specified | 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). | All analyses will be performed by study arm using an Intent-to-Treat (ITT) population defined as all randomized participants across all three arms. Missing data was accounted for in the overall number of participants analyzed. | Posted | Mean | Standard Deviation | units on a scale | From baseline to end of treatment at day 90 |
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | steps per day | From day 1 to end of treatment at day 90 |
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | units on a scale | From day 1 to end of treatment at day 90 |
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| Other Pre-specified | 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. | All analyses will be performed by study arm using an Intent-to-Treat (ITT) population defined as all randomized participants across all three arms. Missing data was accounted for in the overall number of participants analyzed. | Posted | Count of Participants | Participants | Measured at end of treatment at day 90 |
|
|
|
|
| 0 |
| 127 |
| 3 |
| 127 |
| 25 |
| 127 |
| EG001 | 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 EaseVRx, and the functionality of the user interface used to access the experiences is the same. Modifications were made to the appearance of the user interface in order to remove aspects that were added for therapeutic benefit. 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 Activity Tracker: Participants among all arms were given the option to passively wear a Fitbit Charge 4 throughout their 90-day study enrollment period. The Fitbit collected biometric data such as daily steps, heart rate, hours of sleep, stages of sleep, and sleep efficiency. | 0 | 127 | 1 | 127 | 19 | 127 |
| EG002 | 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. 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 Activity Tracker: Participants among all arms were given the option to passively wear a Fitbit Charge 4 throughout their 90-day study enrollment period. The Fitbit collected biometric data such as daily steps, heart rate, hours of sleep, stages of sleep, and sleep efficiency. | 0 | 131 | 3 | 131 | 35 | 131 |
|
| Cardiac Arrest and Sepsis | Cardiac disorders | Non-systematic Assessment | Cardiac arrest and sepsis from 8/20/2023 to 8/25/2023. Event was unrelated to intervention, unexpected, severe and resolved with treatment. Participant continued to use the intervention. |
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| Unexpected fall and fever | Infections and infestations | Non-systematic Assessment | Participant was hospitalized after fall and fever from 5/6/2021 to 5/8/2021. Event was unrelated to intervention, marked as severe, unexpected and resolved with treatment. Participant continued use of intervention. |
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| Hand Infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Hospitalization due to bacterial infection of the hand from 3/11/2021 to 3/19/2021. Event was unrelated to the intervention, severe, unexpected and resolved with treatment. Participant continued use of the intervention. |
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| Acute-on-chronic Low Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Participant was hospitalized for intractable, acute-on-chronic low back pain. Event was unrelated to intervention, marked as severe, unexpected and resolved with treatment. Participant continued use of intervention. |
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| Confusion | Psychiatric disorders | Non-systematic Assessment | Participant was hospitalized from 3/17/2023 to 3/23/2023. Event was unrelated to intervention, marked as severe, unexpected and resolved with treatment. Participant continued use of intervention. |
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| Cervical fusion | Surgical and medical procedures | Non-systematic Assessment | Cervical fusion during the study requiring inpatient rehab hospitalization from 4/17/2023 to 4/27/2023. Event was unrelated to intervention, marked as severe, unexpected and resolved with treatment. Participant continued use of intervention. |
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| Skin Allergic Reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Blurry Vision | Eye disorders | Non-systematic Assessment |
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| Corneal Irritation | Eye disorders | Non-systematic Assessment |
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| Cybersickness | Product Issues | Non-systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Discomfort | Product Issues | Non-systematic Assessment |
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| Dizziness | Ear and labyrinth disorders | Non-systematic Assessment |
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| Eye Hemorrhage | Eye disorders | Non-systematic Assessment |
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| Eye Strain | Eye disorders | Non-systematic Assessment |
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| Difficulty Focusing | Nervous system disorders | Non-systematic Assessment |
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| Face Pain | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Heart Palpitations | Cardiac disorders | Non-systematic Assessment |
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| Flu | Infections and infestations | Non-systematic Assessment |
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| Insomnia | Nervous system disorders | Non-systematic Assessment |
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| Lightheadedness | Ear and labyrinth disorders | Non-systematic Assessment |
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| Migraines | Nervous system disorders | Non-systematic Assessment |
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| Motion Sickness | Ear and labyrinth disorders | Non-systematic Assessment |
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| Upper back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Bacterial Infection | General disorders | Non-systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Vertigo | Nervous system disorders | Non-systematic Assessment |
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| Knee Injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Day 90 - baseline |
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| Other |
The inference will be based on the treatment comparison of least squares means for Day 60, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero. |
| The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate. | Mixed Models Analysis | 0.6328 | A two-sided test performed at the 0.05 level of significance. | Difference in Least Squares Means | -0.42 | 2-Sided | 95 | -2.13 | 1.30 | Skills-Based VR - Sham VR | Other | The inference will be based on the treatment comparison of least squares means for Day 60, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero. |
| The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate. | Mixed Models Analysis | 0.1260 | A two-sided test performed at the 0.05 level of significance. | Difference in Least Squares Means | 1.16 | 2-Sided | 95 | -0.33 | 2.64 | Distraction-Based VR - Sham VR | Other | The inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero. |
| The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate. | Mixed Models Analysis | 0.5150 | A two-sided test performed at the 0.05 level of significance. | Difference in Least Squares Means | -0.51 | 2-Sided | 95 | -2.05 | 1.03 | Skills-Based VR - Sham VR | Other | The inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero. |
| Other |
Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero. |
| The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PCS SF-6 score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PCS SF-6 t-score as a continuous covariate. | Mixed Models Analysis | 0.5742 | A two-sided test performed at the 0.05 level of significance. | Difference in Least Squares Means | -0.33 | 2-Sided | 95 | -1.48 | 0.82 | Skills-Based VR - Sham VR | Other | Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero. |
| Other |
Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero. |
| The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Anxiety score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Anxiety t-score as a continuous covariate. | Mixed Models Analysis | 0.5279 | A two-sided test performed at the 0.05 level of significance. | Difference in Least Squares Means | 0.63 | 2-Sided | 95 | -1.34 | 2.60 | Skills-Based VR - Sham VR | Other | Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero. |
| Other |
Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero. |
| The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Sleep Disturbance score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Sleep Disturbance t-score as a continuous covariate. | Mixed Models Analysis | 0.7006 | A two-sided test performed at the 0.05 level of significance. | Difference in Least Squares Means | -0.33 | 2-Sided | 95 | -2.04 | 1.37 | Skills-Based VR - Sham VR | Other | Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero. |
| Day 90 |
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| The Cochran-Mantel-Haenszel (CMH) test was used to compare the association between time (baseline and day 90) and response (yes or no) while stratifying for the treatment groups. The null hypothesis is that the common odds ratio of the association between time and response across the treatment groups is equal to 1, versus the alternative hypothesis that the common odds ratio is not equal to 1. | Cochran-Mantel-Haenszel | 0.3670 | A two-sided test performed at the 0.05 level of significance without the continuity correction. | Common Odds Ratio | 0.83 | 2-Sided | 95 | 0.55 | 1.24 | Other |
| Other |
Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero. |
| The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS- PF score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PF t-score as a continuous covariate. | Mixed Models Analysis | 0.9569 | A two-sided test performed at the 0.05 level of significance. | Difference in Least Squares Means | -0.04 | 2-Sided | 95 | -1.31 | 1.24 | Skills-Based VR - Sham VR | Other | Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero. |
| Other |
Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero. |
| The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Depression score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Depression t-score as a continuous covariate. | Mixed Models Analysis | 0.6427 | A two-sided test performed at the 0.05 level of significance. | Difference in Least Squares Means | 0.43 | 2-Sided | 95 | -1.40 | 2.26 | Skills-Based VR - Sham VR | Other | Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero. |
| Other |
The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly steps between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero. |
| The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly steps obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline average weekly steps as a continuous covariate. | Mixed Models Analysis | 0.4842 | A two-sided test performed at the 0.05 level of significance. | Difference in Least Squares Means | 405.68 | 2-Sided | 95 | -741.79 | 1553.15 | Skills-Based VR - Sham VR | Other | The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly steps between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero. |
| Other |
The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly sleep scores between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero. |
| The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly sleep scores obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline sleep score as a continuous covariate. | Mixed Models Analysis | 0.8363 | A two-sided test performed at the 0.05 level of significance. | Difference in Least Squares Means | -0.28 | 2-Sided | 95 | -2.92 | 2.37 | Skills-Based VR - Sham VR | Other | The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly sleep scores between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero. |
| Responder status ("Yes" vs. "No") will be analyzed as the dependent variable using logistic regression, with terms for treatment groups and baseline PROMIS-PI as predictors. The null hypothesis is that there is no difference between the treatment groups, versus the alternative hypothesis that there a difference exists between the treatment groups. | Regression, Logistic | 0.280 | A two-sided test performed at the 0.05 level of significance. | Odds Ratio (OR) | 1.35 | 2-Sided | 95 | 0.78 | 2.36 | Sham VR as the reference group. | Other |