Clinical trial NCT04010266: RelieVRx for Total Knee Arthroplasty (TKA) for the Reduction of Acute Postoperative Pain and Opioid Use
Official title: Safety and Effectiveness of Virtual Reality Utilizing RelieVRx for Total Knee Arthroplasty (TKA) for the Reduction of Acute Postoperative Pain and Opioid Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Arthropathy of Knee
Pain, Postoperative
Lead sponsor: AppliedVR Inc.
Sponsor class: INDUSTRY
Collaborators: name: Geisinger Clinic
name: National Institute on Drug Abuse (NIDA)
First posted: 2019-07-08
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute Postoperative Pain
timeFrame: 90 days
measure: Opioid Consumption
timeFrame: 90 days
Secondary outcomes:
measure: KOOS Jr. Score
timeFrame: 90 days
measure: Veterans RAND 12 Health Survey (VR-12) - Physical Component Score
timeFrame: 90 days
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger South Wilkes Barre
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Dr. Michael Suk
role: PRINCIPAL_INVESTIGATOR
References: