N/A
Completed N=63
RelieVRx for Total Knee Arthroplasty (TKA) for the Reduction of Acute Postoperative Pain and Opioid Use
Opioid Use Disorder · Arthropathy of Knee · Pain, Postoperative
Source: ClinicalTrials.gov NCT04010266 ↗
Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Acute Postoperative Pain — 5.13; 4.42 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Postoperative Pain |
5.13; 4.42 | — |
| PRIMARY Opioid Consumption |
-28.0; -34.8 | — |
| SECONDARY KOOS Jr. Score |
27.6; 32.2 | — |
| SECONDARY Veterans RAND 12 Health Survey (VR-12) - Physical Component Score |
7.2; 9.5 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is ≥ 18 years old
- Subject is willing and able to read, comprehend, and sign the study informed consent form in English prior to study specific procedure
- Subject is scheduled for Total Knee Arthroplasty (TKA) surgery
- Subject has a score of 1-3 based on the American Society of Anesthesiologists Physical Status Classification System
- Subject attended the pre-op Total Joint Arthroplasty Patient Education class (Proven Recovery Program©)
- Subject agrees to be enrolled in Force Therapeutics, a web-based, digital rehabilitation and education program
- Subject has family member or community support during post-surgical recovery period
Exclusion Criteria
- Diagnosed with chronic pain syndrome
- Body Mass Index (BMI) ≥ 40
- Current tobacco user at time of surgery
- Uncontrolled sleep apnea
- Bilateral TKA
- Current or recent history (in past year) of substance abuse disorder
- Uncontrolled diabetes (HbA1c ≥ 7.0) 7.8 at time of surgery
- History of Pulmonary Embolism (PE) or Deep Vein Thrombosis (DVT)
- Currently being treated with blood thinners at time of surgery
- Diagnosis of Rheumatoid Arthritis (RA)
- Has Methicillin-resistant Staphylococcus aureus (MRSA)
- Currently pregnant/breastfeeding or planning to in the next 3 months
- Comorbidities including neurological, psychosocial, sensory, or other disorders that may impact pain perception
- Diagnosis of epilepsy, dementia, migraines, or other neurological disorders that may prevent VR usage, and/or other medical conditions predisposed to nausea and dizziness
- Hypersensitivity to flashing lights or motion
- Claustrophobia
- Lack of stereoscopic vision
- Severe hearing impairment
- Injury to eyes, face, or neck that prevents comfortable VR usage
Data sourced from ClinicalTrials.gov (NCT04010266). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.