Trial Outcomes & Findings for RelieVRx for Total Knee Arthroplasty (TKA) for the Reduction of Acute Postoperative Pain and Opioid Use (NCT NCT04010266)
NCT ID: NCT04010266
Last Updated: 2024-02-14
Results Overview
Visual Analog Pain scale; worst 0-10 best
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
90 days
Results posted on
2024-02-14
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
|
Overall Study
COMPLETED
|
24
|
18
|
|
Overall Study
NOT COMPLETED
|
8
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RelieVRx for Total Knee Arthroplasty (TKA) for the Reduction of Acute Postoperative Pain and Opioid Use
Baseline characteristics by cohort
| Measure |
Standard of Care Group
n=32 Participants
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
|
Standard of Care + RelieVRx Group
n=31 Participants
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
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
51.4 years
STANDARD_DEVIATION 13.8 • n=107 Participants
|
50.9 years
STANDARD_DEVIATION 13.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Numerical Pain Rating Scale
|
5.78 units on a scale
STANDARD_DEVIATION 1.54 • n=99 Participants
|
5.76 units on a scale
STANDARD_DEVIATION 1.34 • n=107 Participants
|
5.77 units on a scale
STANDARD_DEVIATION 1.44 • n=206 Participants
|
PRIMARY outcome
Timeframe: 90 daysVisual Analog Pain scale; worst 0-10 best
Outcome measures
| Measure |
Standard of Care Group
n=32 Participants
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
|
Standard of Care + RelieVRx Group
n=31 Participants
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
|
|---|---|---|
|
Acute Postoperative Pain
|
5.13 units on a scale
Standard Deviation 1.79
|
4.42 units on a scale
Standard Deviation 1.17
|
PRIMARY outcome
Timeframe: 90 daysPopulation: 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
Morphine Milligram Equivalents (MME)
Outcome measures
| Measure |
Standard of Care Group
n=24 Participants
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
|
Standard of Care + RelieVRx Group
n=18 Participants
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
|
|---|---|---|
|
Opioid Consumption
|
-28.0 Morphine Milligram Equivalents (MME)
Interval -35.0 to -23.5
|
-34.8 Morphine Milligram Equivalents (MME)
Interval -37.0 to -23.5
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Change in KOOS Jr from Pre-surgery to post-surgery, median (IQR)
short form of knee injury and osteoarthritis outcome score; worst 0 - 100 best
Outcome measures
| Measure |
Standard of Care Group
n=24 Participants
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
|
Standard of Care + RelieVRx Group
n=18 Participants
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
|
|---|---|---|
|
KOOS Jr. Score
|
27.6 score on a scale
Interval 17.5 to 38.0
|
32.2 score on a scale
Interval 21.2 to 42.0
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Change in VR-12 from Pre-surgery to post-surgery, median (IQR)
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.
Outcome measures
| Measure |
Standard of Care Group
n=24 Participants
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
|
Standard of Care + RelieVRx Group
n=18 Participants
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
|
|---|---|---|
|
Veterans RAND 12 Health Survey (VR-12) - Physical Component Score
|
7.2 score on a scale
Interval 2.0 to 11.4
|
9.5 score on a scale
Interval 4.0 to 12.8
|
Adverse Events
Standard of Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care + RelieVRx Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place