Frequently Asked Questions

What is a clinical trial?

Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (such as our VR Headset equipped with EaseVRx*) is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.

Who is AppliedVR?

AppliedVR is pioneering virtual reality (VR) therapeutics for pain. By establishing world-class research and commercial partnership, AppliedVR continues to build an infrastructure designed to establish VR as a standard of care for pain. As the most extensively used and deeply researched therapeutic VR platform in healthcare, AppliedVR is the first company to make general wellness VR widely available in clinical care.

How will I know my information will be secure?

Your survey answers will be stored initially with Curebase in a password protected, HIPAA compliant, electronic format. Data will later be encrypted with a unique identifier that will allow it to be matched to your healthcare claims data if it is available. Data, including information about your use of the VR headset, will be downloaded and stored in a secure and encrypted cloud-based software (AWS) and in password-protected databases (Excel, Google Drive, and SAS). Databases will have a participant number and no personal identifiers associated with the survey responses or healthcare utilization data.

We will do our best to make sure that your personal information collected as part of this study is kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other identifiable personal information will not be used. Organizations that may look at and/or copy your survey responses for research, quality assurance, and data analysis include: the Institutional Review Board, accrediting agencies, government and regulatory groups (such as Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), etc.), safety monitors, companies that sponsor the study, and authorized representatives of the sponsor.

As part of this study, you will be required to use two applications in addition to the AppliedVR system. Curebase will be used for data collection, including the surveys. PayPal will be used to pay the stipend. You will need to agree to the Curebase Terms of Use available at https://www.curebase.com/site/terms-of-use, and the PayPal Terms of Use available at https://www.paypal.com/us/webapps/mpp/ua/useragreement-full, to participate in this study.

How can I contact you?

Our business hours are 6:00 a.m. - 5:00 p.m. Pacific Time, Monday through Friday. We offer many ways to contact us for your convenience, including live chat, text message, phone, and email.

What is the purpose of this study?

The purpose of this study is to evaluate the effectiveness of an investigational medical device by offering an eight-week digital therapeutic program for the management of chronic lower back pain. Additionally, this study aims to understand healthcare utilization and cost for chronic lower back pain.

How will I know if I am eligible for this study?

Before you can begin this study, you will need to complete a pre-screen survey so we can ensure you meet the eligibility requirements. Afterward, you will receive confirmation from us letting you know whether or not you have met the eligibility requirements. In either case, we appreciate your interest in the study.

I’m eligible. What’s next?

Please complete the baseline and at least two out of five pre-treatment surveys during the next 10-day period to become eligible to participate in the study. If you cannot complete the baseline and pre-treatment surveys, then you will not be randomized to the different VR treatments and will be excluded from the study. The optional incentivized survey is not part of the five pre-treatment surveys. In order to receive a VR headset, you must fill out the surveys within the 10-day period. Each survey will take approximately 1-15 minutes to complete.

Why am I ineligible for this study?

Participants who meet any of the following criteria will be excluded from participating in this study:

1. Unable to understand the goals of the study due to cognitive difficulty.
2. Any medical condition that may prevent the use of virtual reality (e.g., current or prior diagnosis of epilepsy, seizure disorder, hypersensitivity to flashing light or motion, migraines, any medical condition predisposing a patient to nausea or dizziness, dementia, absence of stereoscopic vision or severe hearing impairment).
3. Injury to eyes, face or neck that prevents comfortable use of VR.
4. Back pain linked to a cancer-related diagnosis.
5. Indications of challenges related to emotional well-being.
6. Previous participation in the 2020 AVR EaseVRx* pivotal study.
7. Current or recent participation (i.e., within the last two months) in any other research study involving a drug, device, vaccine or other interventional treatment product; or plans to participate in another research study over the next 24 months.

How often will I have to complete a survey?

You will have to complete at least three pre-treatment surveys prior to the eight-week program. Once the program has started, you will complete two surveys each week for eight weeks. Each survey will take approximately 1-15 minutes to complete. You will also be asked to complete follow-up surveys. The follow-up survey intervals will be: 1-, 2-, 3-, 6-, 12-, 18- and 24-months after the conclusion of the eight-week program. You will have the option to take additional surveys for additional incentives.

How will I receive my VR headset?

Once you have met the eligibility requirements and completed the baseline and pre-treatment surveys, our team will be notified that you are ready to receive your virtual reality headset. Once the headset is shipped, you will receive an email with further instructions, including a FedEx tracking number.

Do I have to pay for the VR headset?

No. This will be prepaid for you. You will not incur any costs during this study.

How will I return my VR kit?

Each VR kit will come with a prepaid FedEx shipping label. Please keep this in a safe place throughout the duration of the study. Using this label for shipping, you can drop off your virtual reality kit package at any FedEx Office location or schedule a pickup for free.

What should I expect when participating in the study?

Once accepted in the the eight-week trial:

• One VR session a day (range of 2-16 minutes in length)
• Answer weekly questions via convenient online surveys (2-3 min each survey)
• 1-, 2-, 3-, 6-, 12-, 18-, 24-months Follow Up Surveys (5-15 min each survey)
• Optional incentivized surveys (5-10 min each survey)

*Half of participants keep the virtual reality kits for an additional eight-weeks.

What is the process to get a VR headset?

You will receive a FedEx confirmation email with the tracking number. The VR headset should arrive within two days of the email. A prepaid FedEx shipping label will arrive with your headset. Keep the label in a safe place. Once you have received your headset, please confirm receipt by clicking on the link provided in your email. There will be an instruction guide provided with your headset along with an email detailing further instructions to start the VR program. You will have the option to connect your headset to Wi-Fi for an additional $50. This will be added to your total PayPal payment.

What are the optional incentivized surveys?

These surveys provide us with additional information to analyze for the study. They will be administered: (1) one day after you complete the baseline survey; (2) one day after the end of the eight-week VR program; (3) at these intervals: 1-, 2-, 3-, 6-, 12-, 18-, and 24-months after completing the 8-week VR program. Each optional survey will take approximately 5-6 minutes to complete. You will receive $10-15 for each optional survey you complete.

How will I be compensated?

Payment will be disbursed through PayPal. This allows us to securely and quickly deposit money into your account. Setting up a PayPal account is simple and free of charge. By creating a paypal account, you can ensure your stipend is transferred directly to your bank account without being at risk. Find out more at paypal.com. Unfortunately, we cannot support other payment methods at this time. Gift cards will not be issued for this study.

How much can I be compensated for participating in the study?

By participating in the study, you may receive up to $845. Your total compensation will be based on the number of surveys you complete and returning the virtual reality kit in good condition.

Please review the compensation breakdown:

• Minimum Stipend 100% Completion Required Activities: Compensation $670
• Optional Weekly Activities Completion: Compensation $10-$15 each, totalling $125
• Optional WiFi Connection: Compensation $50
• Maximum Stipend 100% Completion Required & Optional Activities: Compensation up to $845
• Stipend will be distributed in nine separate payments: following your baseline survey, your completion of the eight-week program, and following each follow-up survey. You will not receive payments 2-9 until you return your device.

What do I need to know if I’m in the eight-week long virtual reality treatment group(s)?

Please note the following important points:

• Complete only (1) ONE VR program per day (2-16 minutes)
• Complete surveys every 3-4 days (twice per week, 1-3 minutes each)
• Check email for weekly updates

What comes after the eight-week long virtual reality treatment?

After eight-weeks with the VR program, follow-up surveys will be administered at 1-, 2-, 3-, 6-, 12-, 18-, and 24-months after the initial eight-week VR program for everyone. For the people in the sixteen-week VR program, the 1- and 2-months follow-up surveys will fall in the second eight-week on demand access portion.

What do I need to know if I’m in the sixteen-week long virtual reality treatment group(s)?

After the eight-week program, you will have on-demand access to all of the VR programs that you experienced throughout the study. You may use the VR headset as frequently as you wish for eight weeks following the study. For the second eight-week period with the on-demand access, there will only be monthly surveys.

Do I need to connect my VR headset to WiFi?

A WiFi or internet connection is only required to complete the surveys, but is not required to use the headset. However, you can earn an additional one-time payment of $50 for connecting your VR headset to WiFi.