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EaseVRx for Chronic Lower Back Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Chronic Lower Back Pain+2 MoreEaseVRx - Device
Eligibility
18 - 85
All Sexes
What conditions do you have?
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Study Summary

This trial will compare outcomes for people with chronic low back pain who receive virtual reality therapy against those who don't.

Eligible Conditions
  • Chronic Lower Back Pain
  • Depression
  • Anxiety

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 4 Secondary · Reporting Duration: The outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment

Day 56
Brief Pain Inventory (BPI) questionnaire
Month 24
Oswestry Disability Index score (ODI v2.1b)
PROMIS Anxiety
PROMIS Depression
PROMIS Sleep Disturbance

Trial Safety

Safety Progress

1 of 3

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1
Web-module for patient education and planning
3
duloxetine
3
Duloxetine

Trial Design

4 Treatment Groups

56-day skills-based VR program
1 of 4
56-day skills-based VR program followed by an extended 56-day on-demand period
1 of 4
56-day control (Sham VR)
1 of 4
• 56-day control (Sham VR plus 8w extended on-demand)
1 of 4

Experimental Treatment

Non-Treatment Group

1000 Total Participants · 4 Treatment Groups

Primary Treatment: EaseVRx · Has Placebo Group · N/A

56-day skills-based VR program
Device
Experimental Group · 1 Intervention: EaseVRx · Intervention Types: Device
56-day skills-based VR program followed by an extended 56-day on-demand period
Device
Experimental Group · 1 Intervention: EaseVRx · Intervention Types: Device
56-day control (Sham VR)
Device
ShamComparator Group · 1 Intervention: Sham VR · Intervention Types: Device
• 56-day control (Sham VR plus 8w extended on-demand)
Device
ShamComparator Group · 1 Intervention: Sham VR · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: the outcome measure is administered at baseline, day 56 (end of treatment), and 1, 2, 3, 6, 12, 18, 24 months post treatment

Who is running the clinical trial?

AppliedVR Inc.Lead Sponsor
10 Previous Clinical Trials
2,028 Total Patients Enrolled
Todd Maddox, Ph.D.Principal InvestigatorAppliedVR Inc.

Eligibility Criteria

Age 18 - 85 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a male or female adult aged 18-85.
You have self-reported chronic low back pain that will be confirmed with claims data when available.
You are able to give voluntary, written informed consent to participate in this study.
You have access to the Internet for the duration of your study participation.
You have access to a smartphone or computer for the duration of the study.
You must have a physical mailing address that is not a PO box address for receipt of the device.
You have average pain intensity score of ≥ 4 and average pain interference score of ≥ 4 on the 0-10 Brief Pain Inventory (BPI) Pain Scale for the past month at screening.
You are willing and able to comply with all study procedures including all required restrictions for the duration of study participation.
You must be able to communicate in English.
References

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