Arthropathy of Knee, Opioid Use, Pain, Postoperative
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICERelieVRx headset
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
Sponsors
Geisinger Clinic
National Institute on Drug Abuse (NIDA)
AppliedVR Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is ≥ 18 years old 2. Subject is willing and able to read, comprehend, and sign the study informed consent form in English prior to study specific procedure 3. Subject is scheduled for Total Knee Arthroplasty (TKA) surgery 4. Subject has a score of 1-3 based on the American Society of Anesthesiologists Physical Status Classification System 5. Subject attended the pre-op Total Joint Arthroplasty Patient Education class (Proven Recovery Program©) 6. Subject agrees to be enrolled in Force Therapeutics, a web-based, digital rehabilitation and education program 7. Subject has family member or community support during post-surgical recovery period
Exclusion criteria
1. Diagnosed with chronic pain syndrome 2. Body Mass Index (BMI) ≥ 40 3. Current tobacco user at time of surgery 4. Uncontrolled sleep apnea 5. Bilateral TKA 6. Current or recent history (in past year) of substance abuse disorder 7. Uncontrolled diabetes (HbA1c ≥ 7.0) 7.8 at time of surgery 8. History of Pulmonary Embolism (PE) or Deep Vein Thrombosis (DVT) 9. Currently being treated with blood thinners at time of surgery 10. Diagnosis of Rheumatoid Arthritis (RA) 11. Has Methicillin-resistant Staphylococcus aureus (MRSA) 12. Currently pregnant/breastfeeding or planning to in the next 3 months 13. Comorbidities including neurological, psychosocial, sensory, or other disorders that may impact pain perception 14. Diagnosis of epilepsy, dementia, migraines, or other neurological disorders that may prevent VR usage, and/or other medical conditions predisposed to nausea and dizziness 15. Hypersensitivity to flashing lights or motion 16. Claustrophobia 17. Lack of stereoscopic vision 18. Severe hearing impairment 19. Injury to eyes, face, or neck that prevents comfortable VR usage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Postoperative Pain | 90 days | Visual Analog Pain scale; worst 0-10 best |
| Opioid Consumption | 90 days | Morphine Milligram Equivalents (MME) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KOOS Jr. Score | 90 days | short form of knee injury and osteoarthritis outcome score; worst 0 - 100 best |
| Veterans RAND 12 Health Survey (VR-12) - Physical Component Score | 90 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 32 |
| 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 | 31 |
| Total | 63 |
Baseline characteristics
| Characteristic | Standard of Care Group | Standard of Care + RelieVRx Group | Total |
|---|---|---|---|
| Age, Continuous | 50.3 years STANDARD_DEVIATION 12.5 | 51.4 years STANDARD_DEVIATION 13.8 | 50.9 years STANDARD_DEVIATION 13.2 |
| Numerical Pain Rating Scale | 5.78 units on a scale STANDARD_DEVIATION 1.54 | 5.76 units on a scale STANDARD_DEVIATION 1.34 | 5.77 units on a scale STANDARD_DEVIATION 1.44 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 30 Participants | 29 Participants | 59 Participants |
| Sex: Female, Male Female | 15 Participants | 14 Participants | 29 Participants |
| Sex: Female, Male Male | 17 Participants | 17 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 31 |
| other Total, other adverse events | 0 / 32 | 0 / 31 |
| serious Total, serious adverse events | 0 / 32 | 0 / 31 |
Outcome results
Primary
Acute Postoperative Pain
Visual Analog Pain scale; worst 0-10 best
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care Group | Acute Postoperative Pain | 5.13 units on a scale | Standard Deviation 1.79 |
| Standard of Care + RelieVRx Group | Acute Postoperative Pain | 4.42 units on a scale | Standard Deviation 1.17 |
Primary
Opioid Consumption
Morphine Milligram Equivalents (MME)
Time frame: 90 days
Population: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care Group | Opioid Consumption | -28.0 Morphine Milligram Equivalents (MME) |
| Standard of Care + RelieVRx Group | Opioid Consumption | -34.8 Morphine Milligram Equivalents (MME) |
Secondary
KOOS Jr. Score
short form of knee injury and osteoarthritis outcome score; worst 0 - 100 best
Time frame: 90 days
Population: Change in KOOS Jr from Pre-surgery to post-surgery, median (IQR)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care Group | KOOS Jr. Score | 27.6 score on a scale |
| Standard of Care + RelieVRx Group | KOOS Jr. Score | 32.2 score on a scale |
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.
Time frame: 90 days
Population: Change in VR-12 from Pre-surgery to post-surgery, median (IQR)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care Group | Veterans RAND 12 Health Survey (VR-12) - Physical Component Score | 7.2 score on a scale |
| Standard of Care + RelieVRx Group | Veterans RAND 12 Health Survey (VR-12) - Physical Component Score | 9.5 score on a scale |