NCT04010266

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

Completed NA Results posted Last updated 14 February 2024

What this trial tests

NA trial testing RelieVRx headset in Opioid Use in 63 participants. Completed in 31 August 2023.

Timeline

1 March 2021

Primary endpoint
31 August 2022

31 August 2023

Quick facts

Lead sponsor	AppliedVR Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	63
Start date	1 March 2021
Primary completion	31 August 2022
Estimated completion	31 August 2023
Sites	3 locations across United States

Drugs / interventions tested

• RelieVRx headset
• multi-modality pain management — full drug profile →

Conditions studied

• Opioid Use — all drugs for Opioid Use →
• Arthropathy of Knee — all drugs for Arthropathy of Knee →
• Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

AppliedVR Inc. — full company profile →

Who can join

18 and older, any sex, with Opioid Use or Arthropathy of Knee. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Acute Postoperative Pain Primary · 90 days

Visual Analog Pain scale; worst 0-10 best

Group	Value	95% CI
Standard of Care Group	5.13	± 1.79
Standard of Care + RelieVRx Group	4.42	± 1.17

Opioid Consumption Primary · 90 days

Morphine Milligram Equivalents (MME)

Group	Value	95% CI
Standard of Care Group	-28.0	-35.0 – -23.5
Standard of Care + RelieVRx Group	-34.8	-37.0 – -23.5

KOOS Jr. Score Secondary · 90 days

short form of knee injury and osteoarthritis outcome score; worst 0 - 100 best

Group	Value	95% CI
Standard of Care Group	27.6	17.5 – 38.0
Standard of Care + RelieVRx Group	32.2	21.2 – 42.0

Veterans RAND 12 Health Survey (VR-12) - Physical Component Score Secondary · 90 days

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.

Group	Value	95% CI
Standard of Care Group	7.2	2.0 – 11.4
Standard of Care + RelieVRx Group	9.5	4.0 – 12.8

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Adjunct Digital Interventions Improve Opioid-Based Pain Management: Impact of Virtual Reality and Mobile Applications on Patient-Centered Pharmacy Care.
   Giravi HY, Biskupiak Z, Tyler LS, Bulaj G. · · 2022 · cited 12× · PMID 35770137 · DOI 10.3389/fdgth.2022.884047