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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04010266
• Other study ID #: 2019-0388
• Secondary ID: 2R44DA049640
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2024
• Source: AppliedVR Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy of Knee
• Opioid Use
• Pain, Postoperative

Intervention

Device:
• RelieVRx headset
RelieVRx is a virtual reality therapy intended as adjunctive treatment for acute surgical pain

Drug:
• multi-modality pain management
combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids

Locations

Country	Name	City	State
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Geisinger South Wilkes Barre	Wilkes-Barre	Pennsylvania
United States	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
AppliedVR Inc.	Geisinger Clinic, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Postoperative Pain	Visual Analog Pain scale; worst 0-10 best	90 days
Primary	Opioid Consumption	Morphine Milligram Equivalents (MME)	90 days
Secondary	KOOS Jr. Score	short form of knee injury and osteoarthritis outcome score; worst 0 - 100 best	90 days
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.	90 days