NCT04468074

Virtual Reality Treatment for Adults With Chronic Back Pain

Study on the Use of Virtual Reality Neuropsychological Therapy Technology (VRNT) for Chronic Back Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: CognifiSense Inc. · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Participants with chronic back pain will complete an online eligibility questionnaire. After signing a consent form, eligible participants enter a two-week baseline period ("Baseline Period") during which they complete a daily pain survey. Following the Baseline Period all participants complete an MRI scan. After the MRI, scan participants are randomized into a treatment group ("Therapy Group") or a no-intervention group ("Standard of Care Group" or "SOC Group") with a ratio of 1:1 (treatment:SOC). Therapy Group participants receive education about chronic pain. They also participate in sessions to personalize their Virtual Reality (VR) experience, and to complete training on the use of the VR hardware and software. Therapy Group participants complete the treatment for 8 weeks ("Therapy Period"), after which they return the VR equipment. All participants take a second MRI scan approximately 8-weeks after the first MRI; for the Therapy Group this is at the end of the Therapy Period. After the Therapy Period, Therapy Group participants continue to complete daily pain surveys during a two-week follow-up period ("Follow-Up Period"). All participants complete self-reported clinical outcomes and behavioral measures surveys before and after the Baseline Period, 4 weeks after the first MRI (for Therapy Group this is mid-way through the Therapy Period), and before and after the Follow-Up Period. For Therapy Group participants the study ends with the final surveys and an exit interview at the end of the Follow-up Period. Study Extension (Add-on): SOC Group participants may receive the treatment after the Follow-Up period. Those who elect to do so will complete the same set of surveys as the Therapy Group did during the treatment phase; however, since there is no comparison group, data from this study extension is not used in the main outcomes analyses.

Conditions

• Chronic Pain
• Back Pain Lower Back Chronic
• Back Pain

Interventions

Type	Name	Description
DEVICE	Virtual Reality Therapy for Chronic Pain	1. A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy 2. Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises

Timeline

• Start date: 2020-06-09
• Primary completion: 2021-04-13
• Completion: 2021-06-14
• First posted: 2020-07-13
• Last updated: 2022-06-23
• Results posted: 2022-06-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study