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

AppliedVR

Status: Completed

Conditions: Pain, Postoperative; Opioid Use; Arthropathy of Knee

Treatments: Device: RelieVRx headset; Drug: multi-modality pain management

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04010266

2019-0388

2R44DA049640 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 2 patient groups

Standard of care group

Active Comparator group

Description:

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

Treatment:

Drug: multi-modality pain management

Standard of care + RelieVRx group

Experimental group

Description:

Receive standard of care for pain management, plus RelieVRx headset

Treatment:

Device: RelieVRx headset

Drug: multi-modality pain management