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

NCT ID: NCT04010266

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-08-31

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.

Conditions

Opioid Use; Arthropathy of Knee; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Standard of care group

Receive standard of care for pain management, do not receive RelieVRx headset

Group Type: ACTIVE_COMPARATOR

multi-modality pain management

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

RelieVRx headset

Intervention Type: DEVICE

RelieVRx is a virtual reality therapy intended as adjunctive treatment for acute surgical pain

multi-modality pain management

Intervention Type: DRUG

combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids

Interventions

RelieVRx headset

RelieVRx is a virtual reality therapy intended as adjunctive treatment for acute surgical pain

Intervention Type: DEVICE

multi-modality pain management

combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geisinger Clinic

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

AppliedVR Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Michael Suk

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger Medical Center

Danville, Pennsylvania, United States

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, United States

Geisinger South Wilkes Barre

Wilkes-Barre, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2R44DA049640

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019-0388

Identifier Type: -

Identifier Source: org_study_id