NCT04139564

EaseVRx for the Reduction of Chronic Pain and Opioid Use

Safety and Effectiveness of Virtual Reality Utilizing EaseVRx for the Reduction of Chronic Pain and Opioid Use

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: AppliedVR Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

EaseVRx, a software-based virtual reality (VR) medical device, is intended to offer users a prescription pain management tool that manages the symptoms associated with chronic pain and reduces or eliminates the risk of opioid dependence. The investigators will conduct a proof-of-concept randomized study to assess the feasibility and efficacy of using EaseVRx as a 56-day, VR-based, at-home program among 100 chronic low back pain patients by gathering pilot data on the efficacy of the intervention in decreasing pain, reducing opioid/non-opioid pharmacotherapy, and improving pain-related quality of life.

Detailed description

EaseVRx, a software-based virtual reality (VR) medical device, is intended to offer users a prescription pain management tool that manages the symptoms associated with chronic pain and reduces or eliminates the risk of opioid dependence. EaseVRx is based on principles of cognitive behavioral therapy, pain psychology, mindfulness-based stress reduction, biofeedback, and distraction therapy commonly used in interdisciplinary pain rehabilitation programs. The investigators will conduct a proof-of-concept randomized study to assess the feasibility and efficacy of using EaseVRx as a 56-day, VR-based, at-home program among 100 chronic low back pain patients by gathering pilot data on the efficacy of the intervention in decreasing pain, reducing opioid/non-opioid pharmacotherapy, and improving pain-related quality of life. While VR has been tested in academic medical centers and shown to be efficacious in the management of acute pain, this study will investigate the feasibility of VR use at home to manage chronic pain in preparation for a larger efficacy trial.

Conditions

• Chronic Low-back Pain

Interventions

Type	Name	Description
DEVICE	EaseVRx headset	EaseVRx is a virtual reality therapy intended to treat chronic pain
DEVICE	Active control VR sham program	VR, 2d visual wildlife scenes similar to some EaseVRx content

Timeline

• Start date: 2021-01-11
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2019-10-25
• Last updated: 2024-03-27
• Results posted: 2024-03-27

Locations

1 site across 1 country: United States