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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44DA049640 | 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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This is a single-center, prospective, randomized, controlled study of the appliedVR RelieVRx headset in subjects undergoing Total Knee Arthroplasty (TKA). This study will evaluate two primary endpoints - effectiveness of a single use of RelieVRx in the reduction of acute postoperative pain by 20%; and overall effectiveness of RelieVRx as an opioid-sparing intervention, where opioid consumption is reduced by at least 20% over a 90-day postoperative period in the interventional, standard of care (SOC) plus RelieVRx group compared to the control, SOC group.
This is a single-center, prospective, randomized, controlled study of the appliedVR RelieVRx headset in subjects undergoing Total Knee Arthroplasty (TKA). Patients will be randomized to one of the two groups after study enrollment, and patients in the test arm will be educated about the device preoperatively to facilitate its use in the acute post-operative period. The goals of VR will be presented in the context of an alternate method of pain control to opioids. This study will evaluate two primary endpoints - effectiveness of a single use of RelieVRx in the reduction of acute postoperative pain by 20%; and overall effectiveness of RelieVRx as an opioid-sparing intervention, where opioid consumption is reduced by at least 20% over a 90-day postoperative period in the interventional, standard of care (SOC) plus RelieVRx group compared to the control, SOC group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care group | Active Comparator | Receive standard of care for pain management, do not receive RelieVRx headset |
|
| Standard of care + RelieVRx group | Experimental | Receive standard of care for pain management, plus RelieVRx headset |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RelieVRx headset | Device | RelieVRx is a virtual reality therapy intended as adjunctive treatment for acute surgical pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Postoperative Pain | Visual Analog Pain scale; worst 0-10 best | 90 days |
| Opioid Consumption | Morphine Milligram Equivalents (MME) | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| KOOS Jr. Score | short form of knee injury and osteoarthritis outcome score; worst 0 - 100 best | 90 days |
| Veterans RAND 12 Health Survey (VR-12) - Physical Component Score | This is a measure of quality of life. The VR-12 provides a physical component score (i.e., physical health domain) that provides larger weights for four of the domains (physical function, role-physical, bodily pain, and general health). This is a 12 items survey. VR-12 scores are standardized using a T-score metric with a mean of 50 and a standard deviation of 10. Larger values imply greater physical function and quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Michael Suk | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States | ||
| Geisinger Wyoming Valley Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care Group | Receive standard of care for pain management, do not receive RelieVRx headset multi-modality pain management: combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids |
| FG001 | Standard of Care + RelieVRx Group | Receive standard of care for pain management, plus RelieVRx headset RelieVRx headset: RelieVRx is a virtual reality therapy intended as adjunctive treatment for acute surgical pain multi-modality pain management: combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care Group | Receive standard of care for pain management, do not receive RelieVRx headset multi-modality pain management: combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids |
| BG001 | Standard of Care + RelieVRx Group |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Acute Postoperative Pain | Visual Analog Pain scale; worst 0-10 best | Posted | Mean | Standard Deviation | units on a scale | 90 days |
|
4 months for each patient
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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 | Standard of Care Group | Receive standard of care for pain management, do not receive RelieVRx headset multi-modality pain management: combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids |
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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 | Mar 17, 2020 | Nov 23, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| multi-modality pain management | Drug | combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids |
|
| 90 days |
| Wilkes-Barre |
| Pennsylvania |
| 18711 |
| United States |
| Geisinger South Wilkes Barre | Wilkes-Barre | Pennsylvania | 18765 | United States |
Receive standard of care for pain management, plus RelieVRx headset RelieVRx headset: RelieVRx is a virtual reality therapy intended as adjunctive treatment for acute surgical pain multi-modality pain management: combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Numerical Pain Rating Scale | Rating make on a scale from 0 to 10 where 0 implies no pain and 10 implies pain that is unbearable. Thus, increasing values of the Numerical Pain Rating Scale imply greater amounts of pain | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Opioid Consumption | Morphine Milligram Equivalents (MME) | Morphine milligram equivalents were measured preoperatively and postoperatively for each patient. The outcome measure reported is the median change in total MME from pre-op to Post-op | Posted | Median | Inter-Quartile Range | Morphine Milligram Equivalents (MME) | 90 days |
|
|
|
| Secondary | KOOS Jr. Score | short form of knee injury and osteoarthritis outcome score; worst 0 - 100 best | Change in KOOS Jr from Pre-surgery to post-surgery, median (IQR) | Posted | Median | Inter-Quartile Range | score on a scale | 90 days |
|
|
|
| Secondary | Veterans RAND 12 Health Survey (VR-12) - Physical Component Score | This is a measure of quality of life. The VR-12 provides a physical component score (i.e., physical health domain) that provides larger weights for four of the domains (physical function, role-physical, bodily pain, and general health). This is a 12 items survey. VR-12 scores are standardized using a T-score metric with a mean of 50 and a standard deviation of 10. Larger values imply greater physical function and quality of life. | Change in VR-12 from Pre-surgery to post-surgery, median (IQR) | Posted | Median | Inter-Quartile Range | score on a scale | 90 days |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Standard of Care + RelieVRx Group | Receive standard of care for pain management, plus RelieVRx headset RelieVRx headset: RelieVRx is a virtual reality therapy intended as adjunctive treatment for acute surgical pain multi-modality pain management: combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids | 0 | 31 | 0 | 31 | 0 | 31 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |