NCT05263037

EaseVRx-8w+ for the Treatment of Chronic Lower Back Pain

A Decentralized, Randomized, Controlled Trial to Study Health Outcomes of EaseVRx-8w+ for the Treatment of Chronic Lower Back Pain

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,093 (actual)
• Sponsor: AppliedVR Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The aim of this randomized controlled trial (RCT) is to assess outcomes for virtual reality therapy (including pain intensity, pain interference, anxiety, depression, physical function, sleep, behavioral skills development, health outcomes and satisfaction) along with healthcare utilization and costs in participants with Chronic Low Back Pain.

Detailed description

This is a decentralized, randomized controlled trial with four parallel study arms comparing change from pre-treatment to end-of-treatment to 12-months posttreatment in the EaseVRx-8w, EaseVRx-8w plus extended on-demand and Control groups. After consenting to join the study, participants will be randomized and allocated to one of four treatment programs. Study devices will be delivered to the participant's home with instructions for use via FedEx with complementary remote technical support. * participants in the EaseVRx-8w arm will participate in an 8-week interventional program and continue to be followed for 24 months after completion of treatment * participants in the EaseVRx-8w plus extended on-demand arm will enroll in an 8-week interventional program and be offered an extended 8-week ondemand period, and continue to be followed for 24 months after the completion of treatment.• participants in the first control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and continue to be followed for 24 months after the completion of treatment * participants in the second control arm will receive 2D Sham VR virtual reality content during the 8-week interventional program and be offered an extended 8-week on-demand period, after which they will continue to be followed for 24 months after the completion of treatment All trial participants will be monitored for pain intensity and pain interference, physical function, behavioral skills development, health outcomes and satisfaction. Additionally, to assess resource use associated with CLBP, participant data will be run through a secure Datavant matching process to be linked to their healthcare claims data if it is available in the Komodo data set. The claims will provide descriptive characterizations of resource use and healthcare costs associated with CLBP. For participant-level changes in resource use, and for comparisons between study arms, only the participants with complete claims files will be assessed. Claims matched data will capture all interactions with the healthcare system that generate an insurance claim record, which includes such things as physician visits, interventions such as steroid injections, surgery or physical therapy, emergent use of services, medications, and diagnostic procedures. Claims adjudication often lags a few months, so the most robust analyses of utilization will be performed about 6 months after the time point of interest. Health economic modeling will be performed after 1 year to assess the cost and economic outcomes of the EaseVRx intervention.

Conditions

• Chronic Low-back Pain
• Anxiety
• Depression

Interventions

Type	Name	Description
DEVICE	EaseVRx	VR software with interactive content
DEVICE	Sham VR	VR with neutral non-interactive content

Timeline

• Start date: 2022-01-31
• Primary completion: 2022-10-13
• Completion: 2026-06-01
• First posted: 2022-03-02
• Last updated: 2025-01-29
• Results posted: 2023-12-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study