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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
63
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
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
Geisinger South Wilkes Barre
Wilkes-Barre, Pennsylvania, United States
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
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