Opioid UseNCT04010266
RelieVRx for Total Knee Arthroplasty (TKA) for the Reduction of Acute Postoperative Pain and Opioid Use
A study testing RelieVRx headset and multi-modality pain management in people with Opioid Use and Arthropathy of Knee, run by AppliedVR Inc. at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Arthropathy of Knee, Pain, Postoperative
- What is being tested?
- RelieVRx headset and multi-modality pain management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Mar 2021to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Geisinger Medical Center
Danville, Pennsylvania, 17822
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711
Geisinger South Wilkes Barre
Wilkes-Barre, Pennsylvania, 18765
About this study
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
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.
Read the 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.
- Conditions
- Opioid Use, Arthropathy of Knee, Pain, Postoperative
- Being tested
- RelieVRx headset, multi-modality pain management
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RelieVRx headsetDevice
RelieVRx is a virtual reality therapy intended as adjunctive treatment for acute surgical pain
multi-modality pain managementDrug
combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids
| Study group | Role | What they receive |
|---|---|---|
| Standard of care group | Active comparator | Receive standard of care for pain management, do not receive RelieVRx headset Receives: Drug: multi-modality pain management |
| Standard of care + RelieVRx group | Experimental | Receive standard of care for pain management, plus RelieVRx headset Receives: Device: RelieVRx headset; Drug: multi-modality pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Postoperative Pain
Visual Analog Pain scale; worst 0-10 best
Measured: 90 days
Opioid Consumption
Morphine Milligram Equivalents (MME)
Measured: 90 days
Secondary outcomes (2)
KOOS Jr. Score
short form of knee injury and osteoarthritis outcome score; worst 0 - 100 best
Measured: 90 days
Veterans RAND 12 Health Survey (VR-12) - Physical Component Score
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start1 Mar 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- AppliedVR Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Geisinger Clinic, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Dr. Michael Suk, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010266
- Sponsor's protocol ID
- 2019-0388
- Other IDs
- 2R44DA049640
- Status last verified
- Feb 2024
- First submitted
- 3 Jul 2019
- Last updated
- 14 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04010266
- Acronym / sponsor ID
- 2019-0388
- Conditions
- Opioid Use, Arthropathy of Knee, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- AppliedVR Inc.Industry (pharma, biotech, devices)
- Collaborators
- Geisinger Clinic, National Institute on Drug Abuse (NIDA)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Posted 14 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care group | Active comparator | Drug: multi-modality pain managementReceive standard of care for pain management, do not receive RelieVRx headset |
| Standard of care + RelieVRx group | Experimental | Device: RelieVRx headset, Drug: multi-modality pain managementReceive standard of care for pain management, plus RelieVRx headset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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©)
Key exclusion criteria (19 listed)
- Diagnosed with chronic pain syndrome
- Body Mass Index (BMI) ≥ 40
- Current tobacco user at time of surgery
- Uncontrolled sleep apnea
- Bilateral TKA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RelieVRx headsetRelieVRx is a virtual reality therapy intended as adjunctive treatment for acute surgical pain | Device | Standard of care + RelieVRx group |
| multi-modality pain managementcombination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids | Drug | Standard of care + RelieVRx group, Standard of care group |
Primary outcome
Acute Postoperative Pain
Time frame: 90 days
Visual Analog Pain scale; worst 0-10 best
Opioid Consumption
Time frame: 90 days
Morphine Milligram Equivalents (MME)
2 secondary outcomes
KOOS Jr. Score
Time frame: 90 days
Veterans RAND 12 Health Survey (VR-12) - Physical Component Score
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Opioid Use
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Michael Suk principal investigator
Geisinger Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RelieVRx headset and multi-modality pain management in people with Opioid Use and Arthropathy of Knee, run by AppliedVR Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Postoperative Pain (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.