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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44DA050231 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Geisinger Clinic | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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EaseVRx, a software-based virtual reality (VR) medical device, is intended to offer users a prescription pain management tool that manages the symptoms associated with chronic pain and reduces or eliminates the risk of opioid dependence. The investigators will conduct a proof-of-concept randomized study to assess the feasibility and efficacy of using EaseVRx as a 56-day, VR-based, at-home program among 100 chronic low back pain patients by gathering pilot data on the efficacy of the intervention in decreasing pain, reducing opioid/non-opioid pharmacotherapy, and improving pain-related quality of life.
EaseVRx, a software-based virtual reality (VR) medical device, is intended to offer users a prescription pain management tool that manages the symptoms associated with chronic pain and reduces or eliminates the risk of opioid dependence. EaseVRx is based on principles of cognitive behavioral therapy, pain psychology, mindfulness-based stress reduction, biofeedback, and distraction therapy commonly used in interdisciplinary pain rehabilitation programs. The investigators will conduct a proof-of-concept randomized study to assess the feasibility and efficacy of using EaseVRx as a 56-day, VR-based, at-home program among 100 chronic low back pain patients by gathering pilot data on the efficacy of the intervention in decreasing pain, reducing opioid/non-opioid pharmacotherapy, and improving pain-related quality of life. While VR has been tested in academic medical centers and shown to be efficacious in the management of acute pain, this study will investigate the feasibility of VR use at home to manage chronic pain in preparation for a larger efficacy trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EaseVRx group | Experimental | Each subject will be asked to complete a 56-day program using the EaseVRx virtual reality headset with assigned modules each week. Each week, subjects will be asked to complete 7 modules (one per day), each approximately 5 minutes in duration, for a total of 56 modules across the program. |
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| Active control group VR Sham | Active Comparator | Each subject will be asked to complete a program accessible via VR that includes 2d visual wildlife scenes similar to some EaseVRx content |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EaseVRx headset | Device | EaseVRx is a virtual reality therapy intended to treat chronic pain |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain: Numerical Pain Rating Scale | Numerical Pain Rating Scale; scale from 0 to 10 with higher numbers implying greater pain The outcome values presented below are the difference between baseline pain and pain at 12 weeks. Specifically, baseline pain score minus 12 week pain score A positive difference implies that pain was reduced | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Outcome Assessments Completed by Participant | Thirty four assessments were attempted. This measure notes the total number of assessments completed by each participant | 12 weeks |
| Patient Compliance |
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Inclusion Criteria:
Exclusion Criteria:
Exclusions based on potential medical or lifestyle confounders:
Exclusions based on potential drug-related cofounders:
Exclusions based on ability to use EaseVR effectively:
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| Name | Affiliation | Role |
|---|---|---|
| Chulhyun Ahn, MD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | EaseVRx Group | Each subject will be asked to complete a 56-day program using the EaseVRx virtual reality headset with assigned modules each week. Each week, subjects will be asked to complete 7 modules (one per day), each approximately 5 minutes in duration, for a total of 56 modules across the program. EaseVRx headset: EaseVRx is a virtual reality therapy intended to treat chronic pain |
| FG001 | Active Control Group VR Sham | Each subject will be asked to complete a program accessible via VR that includes 2d visual wildlife scenes similar to some EaseVRx content Active control VR sham program: VR, 2d visual wildlife scenes similar to some EaseVRx content |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | EaseVRx Group | Each subject will be asked to complete a 56-day program using the EaseVRx virtual reality headset with assigned modules each week. Each week, subjects will be asked to complete 7 modules (one per day), each approximately 5 minutes in duration, for a total of 56 modules across the program. EaseVRx headset: EaseVRx is a virtual reality therapy intended to treat chronic pain |
| 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, Categorical | Count of Participants |
| 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 | Pain: Numerical Pain Rating Scale | Numerical Pain Rating Scale; scale from 0 to 10 with higher numbers implying greater pain The outcome values presented below are the difference between baseline pain and pain at 12 weeks. Specifically, baseline pain score minus 12 week pain score A positive difference implies that pain was reduced | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
12 weeks
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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 | EaseVRx Group | Each subject will be asked to complete a 56-day program using the EaseVRx virtual reality headset with assigned modules each week. Each week, subjects will be asked to complete 7 modules (one per day), each approximately 5 minutes in duration, for a total of 56 modules across the program. EaseVRx headset: EaseVRx is a virtual reality therapy intended to treat chronic pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Research | AppliedVR | 13108901584 | tmaddox@appliedvr.io |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2020 | Feb 1, 2024 | Prot_SAP_000.pdf |
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| Active control VR sham program | Device | VR, 2d visual wildlife scenes similar to some EaseVRx content |
|
number of VR modules completed. For the EaseVRx group this would be the number of EaseVRx modules completed with worst 0 - 56 best. For the Active control VR Sham group this would be the number of ShamVR modules completed with worst 0 - 56 best.
| 8 weeks |
| Opioid Consumption | Morphine Milligram Equivalents (MME) | 12 weeks |
| BG001 | Active Control Group VR Sham | Each subject will be asked to complete a program accessible via VR that includes 2d visual wildlife scenes similar to some EaseVRx content Active control VR sham program: VR, 2d visual wildlife scenes similar to some EaseVRx content |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Numerical Pain Rating Scale | The scale ranges from 0 to 10 with larger numbers implying greater pain. | Mean | Standard Deviation | units on a scale from 0 to 10 |
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| Active Control Group VR Sham |
Each subject will be asked to complete a program accessible via VR that includes 2d visual wildlife scenes similar to some EaseVRx content Active control VR sham program: VR, 2d visual wildlife scenes similar to some EaseVRx content |
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| Secondary | Number of Outcome Assessments Completed by Participant | Thirty four assessments were attempted. This measure notes the total number of assessments completed by each participant | Posted | Mean | Standard Error | total number of assessments completed | 12 weeks |
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| Secondary | Patient Compliance | number of VR modules completed. For the EaseVRx group this would be the number of EaseVRx modules completed with worst 0 - 56 best. For the Active control VR Sham group this would be the number of ShamVR modules completed with worst 0 - 56 best. | Posted | Mean | Standard Deviation | modules | 8 weeks |
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| Secondary | Opioid Consumption | Morphine Milligram Equivalents (MME) | Posted | Geometric Mean | Standard Error | Morphine Milligram Equivalents(MME) | 12 weeks |
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| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Active Control Group VR Sham | Each subject will be asked to complete a program accessible via VR that includes 2d visual wildlife scenes similar to some EaseVRx content Active control VR sham program: VR, 2d visual wildlife scenes similar to some EaseVRx content | 0 | 55 | 0 | 55 | 0 | 55 |
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