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

NCT04010266 | Completed Results

• 2 other identifiers: 2019-03882R44DA049640
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 3

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.

Conditions

Opioid Use; Arthropathy of Knee; Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

• Acute Postoperative Pain

  Visual Analog Pain scale; worst 0-10 best

  90 days

• Opioid Consumption

  Morphine Milligram Equivalents (MME)

  90 days

Secondary Outcomes (2)

• KOOS Jr. Score

  90 days

• Veterans RAND 12 Health Survey (VR-12) - Physical Component Score

  90 days

Study Arms (2)

Standard of care group

ACTIVE COMPARATOR

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

Drug: multi-modality pain management

Standard of care + RelieVRx group

EXPERIMENTAL

Receive standard of care for pain management, plus RelieVRx headset

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

Interventions

RelieVRx headset DEVICE

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

Standard of care + RelieVRx group

multi-modality pain management DRUG

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

Standard of care + RelieVRx group; Standard of care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AppliedVR Inc.: lead
• Geisinger Clinic: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Geisinger South Wilkes Barre

Wilkes-Barre, Pennsylvania, 18765, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Vice President of Research
• Organization: AppliedVR

tmaddox@appliedvr.io

13108901584

Study Officials

• Dr. Michael Suk

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 8, 2019
• Study Start: March 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2023
• Last Updated: February 14, 2024
• Results First Posted: February 14, 2024

Record last verified: 2024-02

Locations

US (3)