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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010266
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : July 15, 2020
Sponsor:
Collaborator:
Geisinger Clinic
Information provided by (Responsible Party):
AppliedVR Inc.

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.

Condition or disease Intervention/treatment Phase
Opioid Use Arthropathy of Knee Pain, Postoperative Device: RelieVRx headset Drug: multi-modality pain management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Standard of care group
Receive standard of care for pain management, do not receive RelieVRx headset
Drug: multi-modality pain management
combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids

Experimental: Standard of care + RelieVRx group
Receive standard of care for pain management, plus RelieVRx headset
Device: RelieVRx headset
RelieVRx is a virtual reality therapy intended as adjunctive treatment for acute surgical pain

Drug: multi-modality pain management
combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids




Primary Outcome Measures :
  1. acute postoperative pain [ Time Frame: 90 days ]
    Visual Analog Pain scale; worst 0-10 best

  2. opioid consumption [ Time Frame: 90 days ]
    Morphine Milligram Equivalents (MME)


Secondary Outcome Measures :
  1. Post-anesthesia care unit length of stay [ Time Frame: 1 day ]
    number of minutes in Post-anesthesia care unit

  2. Hospital length of stay [ Time Frame: 7 days ]
    number of days admitted in hospital after surgery

  3. Time to initial ambulation [ Time Frame: 7 days ]
    number of hours before patient is weight bearing

  4. KOOS Jr. score [ Time Frame: 12 months ]
    short form of knee injury and osteoarthritis outcome score; worst 0 - 100 best

  5. Veterans RAND 12 Health Survey (VR-12) physical component score [ Time Frame: 12 months ]
    patient's overall perspective of their physical health; worst 15 - 63 best

  6. Number of surgical complications [ Time Frame: 12 months ]
    Surgical complications, such as infection or delayed healing

  7. Clinic and emergency department visits [ Time Frame: 12 months ]
    Number of unscheduled clinic and emergency department visits

  8. Inpatient readmissions for uncontrolled pain [ Time Frame: 12 months ]
    Number of inpatient readmissions for uncontrolled pain



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010266


Contacts
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Contact: Todd Maddox, PhD 5129478494 tmaddox@appliedvr.io
Contact: Derek Nielsen, MS 6508628989 dnielsen@appliedvr.io

Locations
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United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Contact: Jennifer Harding    570-214-4806    orthoresearch@geisinger.edu   
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Jennifer Harding    570-214-4806    orthoresearch@geisinger.edu   
Geisinger South Wilkes Barre
Wilkes-Barre, Pennsylvania, United States, 18765
Contact: Jennifer Harding    570-214-4806    orthoresearch@geisinger.edu   
Sponsors and Collaborators
AppliedVR Inc.
Geisinger Clinic
Investigators
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Principal Investigator: Dr. Michael Suk Geisinger Clinic
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Responsible Party: AppliedVR Inc.
ClinicalTrials.gov Identifier: NCT04010266    
Other Study ID Numbers: 2019-0388
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020

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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
Additional relevant MeSH terms:
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Joint Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Musculoskeletal Diseases