An interventional study of RelieVRx headset and multi-modality pain management in Opioid Use, Arthropathy of Knee and Pain, Postoperative, sponsored by AppliedVR Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-14.
Sponsored by AppliedVR Inc. · Not applicable, Interventional, and Supportive care
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 63 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →AppliedVR Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Receive standard of care for pain management, do not receive RelieVRx headset
Drug: multi-modality pain management
Receive standard of care for pain management, plus RelieVRx headset
Device: RelieVRx headset · Drug: multi-modality pain management
RelieVRx is a virtual reality therapy intended as adjunctive treatment for acute surgical pain
combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids
Acute Postoperative Pain
Visual Analog Pain scale; worst 0-10 best
Time frame: 90 days
Opioid Consumption
Morphine Milligram Equivalents (MME)
Time frame: 90 days
KOOS Jr. Score
short form of knee injury and osteoarthritis outcome score; worst 0 - 100 best
Time frame: 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.
Time frame: 90 days
| Milestone | Standard of Care Group | Standard of Care + RelieVRx Group |
|---|---|---|
| Started | 32 | 31 |
| Completed | 24 | 18 |
| Not completed | 8 | 13 |
Visual Analog Pain scale; worst 0-10 best
| units on a scale | Standard of Care Group | Standard of Care + RelieVRx Group |
|---|---|---|
| Acute Postoperative Pain | 5.13 ± 1.79 | 4.42 ± 1.17 |
Morphine Milligram Equivalents (MME)
| Morphine Milligram Equivalents (MME) | Standard of Care Group | Standard of Care + RelieVRx Group |
|---|---|---|
| Opioid Consumption | -28.0 (-35.0 to -23.5) | -34.8 (-37.0 to -23.5) |
short form of knee injury and osteoarthritis outcome score; worst 0 - 100 best
| score on a scale | Standard of Care Group | Standard of Care + RelieVRx Group |
|---|---|---|
| KOOS Jr. Score | 27.6 (17.5 to 38.0) | 32.2 (21.2 to 42.0) |
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.
| score on a scale | Standard of Care Group | Standard of Care + RelieVRx Group |
|---|---|---|
| Veterans RAND 12 Health Survey (VR-12) - Physical Component Score | 7.2 (2.0 to 11.4) | 9.5 (4.0 to 12.8) |
Collected over 4 months for each patient. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care Group | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Standard of Care + RelieVRx Group | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Age, Continuous(years) | Standard of Care Group | Standard of Care + RelieVRx Group | Total |
|---|---|---|---|
| Mean | 50.3 ± 12.5 | 51.4 ± 13.8 | 50.9 ± 13.2 |
| Sex: Female, Male(Participants) | Standard of Care Group | Standard of Care + RelieVRx Group | Total |
|---|---|---|---|
| Female | 15 | 14 | 29 |
| Male | 17 | 17 | 34 |
| Race (NIH/OMB)(Participants) | Standard of Care Group | Standard of Care + RelieVRx Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 30 | 29 | 59 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Numerical Pain Rating Scale(units on a scale) | Standard of Care Group | Standard of Care + RelieVRx Group | Total |
|---|---|---|---|
| Mean | 5.78 ± 1.54 | 5.76 ± 1.34 | 5.77 ± 1.44 |
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AppliedVR Inc.