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

Primary Purpose

Opioid Use, Arthropathy of Knee, Pain, Postoperative

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RelieVRx headset
multi-modality pain management
Sponsored by
AppliedVR Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Opioid Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Geisinger Medical Center
  • Geisinger Wyoming Valley Medical Center
  • Geisinger South Wilkes Barre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of care group

Standard of care + RelieVRx group

Arm Description

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

Receive standard of care for pain management, plus RelieVRx headset

Outcomes

Primary Outcome Measures

acute postoperative pain
Visual Analog Pain scale; worst 0-10 best
opioid consumption
Morphine Milligram Equivalents (MME)

Secondary Outcome Measures

Post-anesthesia care unit length of stay
number of minutes in Post-anesthesia care unit
Hospital length of stay
number of days admitted in hospital after surgery
Time to initial ambulation
number of hours before patient is weight bearing
KOOS Jr. score
short form of knee injury and osteoarthritis outcome score; worst 0 - 100 best
Veterans RAND 12 Health Survey (VR-12) physical component score
patient's overall perspective of their physical health; worst 15 - 63 best
Number of surgical complications
Surgical complications, such as infection or delayed healing
Clinic and emergency department visits
Number of unscheduled clinic and emergency department visits
Inpatient readmissions for uncontrolled pain
Number of inpatient readmissions for uncontrolled pain

Full Information

First Posted
July 3, 2019
Last Updated
December 18, 2022
Sponsor
AppliedVR Inc.
Collaborators
Geisinger Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04010266
Brief Title
RelieVRx for Total Knee Arthroplasty (TKA) for the Reduction of Acute Postoperative Pain and Opioid Use
Official Title
Safety and Effectiveness of Virtual Reality Utilizing RelieVRx for Total Knee Arthroplasty (TKA) for the Reduction of Acute Postoperative Pain and Opioid Use
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AppliedVR Inc.
Collaborators
Geisinger Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Arthropathy of Knee, Pain, Postoperative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of care group
Arm Type
Active Comparator
Arm Description
Receive standard of care for pain management, do not receive RelieVRx headset
Arm Title
Standard of care + RelieVRx group
Arm Type
Experimental
Arm Description
Receive standard of care for pain management, plus RelieVRx headset
Intervention Type
Device
Intervention Name(s)
RelieVRx headset
Intervention Description
RelieVRx is a virtual reality therapy intended as adjunctive treatment for acute surgical pain
Intervention Type
Drug
Intervention Name(s)
multi-modality pain management
Intervention Description
combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids
Primary Outcome Measure Information:
Title
acute postoperative pain
Description
Visual Analog Pain scale; worst 0-10 best
Time Frame
90 days
Title
opioid consumption
Description
Morphine Milligram Equivalents (MME)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Post-anesthesia care unit length of stay
Description
number of minutes in Post-anesthesia care unit
Time Frame
1 day
Title
Hospital length of stay
Description
number of days admitted in hospital after surgery
Time Frame
7 days
Title
Time to initial ambulation
Description
number of hours before patient is weight bearing
Time Frame
7 days
Title
KOOS Jr. score
Description
short form of knee injury and osteoarthritis outcome score; worst 0 - 100 best
Time Frame
12 months
Title
Veterans RAND 12 Health Survey (VR-12) physical component score
Description
patient's overall perspective of their physical health; worst 15 - 63 best
Time Frame
12 months
Title
Number of surgical complications
Description
Surgical complications, such as infection or delayed healing
Time Frame
12 months
Title
Clinic and emergency department visits
Description
Number of unscheduled clinic and emergency department visits
Time Frame
12 months
Title
Inpatient readmissions for uncontrolled pain
Description
Number of inpatient readmissions for uncontrolled pain
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Michael Suk
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Geisinger Wyoming Valley Medical Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
Geisinger South Wilkes Barre
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18765
Country
United States

12. IPD Sharing Statement

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

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