RelieVRx for Total Knee Arthroplasty (TKA) for the Reduction of Acute Postoperative Pain and Opioid Use

Safety and Effectiveness of Virtual Reality Utilizing RelieVRx for Total Knee Arthroplasty (TKA) for the Reduction of Acute Postoperative Pain and Opioid Use

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Arthropathy of Knee; Opioid Use
• Intervention / Treatment: Drug: multi-modality pain management; Device: RelieVRx headset

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Geisinger Wyoming Valley Medical Center
    • Wilkes-Barre, Pennsylvania, United States, 18765
      • Geisinger South Wilkes Barre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care group; Receive standard of care for pain management, do not receive RelieVRx headset	Drug: multi-modality pain management; combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids
Experimental: Standard of care + RelieVRx group; Receive standard of care for pain management, plus RelieVRx headset	Drug: multi-modality pain management; combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids; Device: RelieVRx headset; RelieVRx is a virtual reality therapy intended as adjunctive treatment for acute surgical pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Postoperative Pain	Visual Analog Pain scale; worst 0-10 best	90 days
Opioid Consumption	Morphine Milligram Equivalents (MME)	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KOOS Jr. Score	short form of knee injury and osteoarthritis outcome score; worst 0 - 100 best	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.	90 days

Collaborators and Investigators

• Sponsor: AppliedVR Inc.
• Collaborators: National Institute on Drug Abuse (NIDA); Geisinger Clinic
• Investigators: Principal Investigator: Dr. Michael Suk, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 10, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2019-0388; 2R44DA049640 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No