Efficacy of the RelieVRx™ program
The RelieVRx program—Now approved for patients with cLBP
The RelieVRx program is indicated as adjunctive treatment for patients with moderate to severe cLBP lasting longer than 3 months.1
Clinically evaluated1,2
The efficacy and safety of the RelieVRx program were evaluated in a randomized, controlled, double-blind trial in patients with cLBP vs a non-immersive control (ShamVR).
In the 8-week clinical trial, 188 participants from 40 states took part in 56 daily VR sessions.
After completing a baseline survey, and at least 1 of 3 pain surveys during the 2-week pre-treatment period, participants were randomized 1:1 to the RelieVRx program orShamVR treatment groups.
(n=94)
Multimodal, skills-based, self-management VR program
Inclusion criteria1,2
Participants ranged in age from 18-85 years with self-reported non-malignant chronic lower back pain for at least 3 months' duration and with an average pain intensity of >4/10 over the past month based on the Defense and Veterans Pain Rating Scale*
Baseline characteristics2
Proven pain reduction
At the end of the 8-week program, significant pain reduction was seen by those who used RelieVRx compared to the non-immersive headset.1,2
Nearly 2 out of 3 patients (65%) in the treatment group had a clinically meaningful* reduction in pain intensity2
Nearly half of patients (46%) in the treatment group experienced a 71% reduction in pain intensity on average2†
Calculated from a group with ≥50% reduction in pain intensity.2
Lasting pain relief over time
Significant pain relief was sustained at 3 months3
No serious adverse events were reported with the RelieVRx2 program
A non-significant difference (P=.50) in nausea and motion sickness was reported between the 2 treatment groups:
• 7/72 (9.7%) from the RelieVRx group
• 5/75 (6.7%) from the Sham VR group
Guidance for managing any side effects is provided in the RelieVRx Information for Use.
Patients rated the RelieVRx program as engaging and easy to use
Engagement and satisfaction
Participants were highly engaged, completing 77% or more of the RelieVRx program and Sham VR programs2
Participants were very satisfied with the RelieVRx program, with a 4.32 satisfaction rating on a 5-point scale2
85% of participants expressed a desire to continue with the program after treatment3
Ease of use
The RelieVRx program was rated 84.33/100 on the System Usability Scale which is considered an A+ in usability according to industry benchmarks2
It was ranked as easier to use than a bank ATM4
Medication use
Over-the-counter analgesics were 18% lower for the RelieVRx program but not for Sham VR (P=.01)2
Learn about the RelieVRx device and established curriculum.
Discover RelieVRx TherapyIndication for Use
The RelieVRx program is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on cognitive behavioral therapy skills and other evidence-based behavioral methods for patients (age 18 and older) with a diagnosis of chronic lower back-pain (defined as moderate to severe pain lasting longer than three months). The device is intended for in-home use for the reduction of pain and pain interference associated with chronic lower back pain.
Contraindications
There are no known contraindications.
References
- RelieVRx [instructions for use]. Van Nuys, CA: AppliedVR, Inc.; 2021.
- Garcia LM, Birckhead BJ, Krishnamurthy P, et al. An 8-week self-administered at-home behavioral skills-based virtual reality program for chronic low back pain: double-blind, randomized, placebo-controlled trial conducted during COVID-19. J Med Internet Res. 2021;23(2):e26292. doi:10.2196/26292
- Garcia LM, Birckhead BJ, Krishnamurthy P, et al. Three-month follow-up results of a double-blind, randomized placebo-controlled trial of 8-week self-administered at-home behavioral skills-based virtual reality (VR) for chronic low back pain. J Pain. 2021.
- AppliedVR Press Release. Accessed January 18, 2022.
RelieVRx was formerly known as EaseVRx.