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NCT04468074 · ClinicalTrials.gov registry record · NA
Virtual Reality Treatment for Adults With Chronic Back Pain
A NA study, sponsored by CognifiSense.
- Completed
- Registry status
- NA
- Development phase
- 72
- Enrollment target
NCT04468074: Completed NA study, sponsored by CognifiSense.
NCT04468074 is a NA study that has completed, run by CognifiSense. The registered enrollment target is 72 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04468074, a NA study, has completed, sponsored by CognifiSense.
- COMPLETED
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
Study 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.
Primary Outcome
Brief Pain Inventory-short form (BPI-SF). Measured on Scale of 0 to 10, 0 = no pain, 10 = worst pain imaginable.
Interventions
- DEVICE Virtual Reality Therapy for Chronic Pain
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2020-06-09 |
| Est. Completion | 2021-06-14 |
| Phase | NA |
What the finished NCT04468074 record still lists
NCT04468074 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Virtual Reality Therapy for Chronic Pain is the first listed.
NCT04468074 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04468074 about?
NCT04468074 is a clinical study titled "Virtual Reality Treatment for Adults With Chronic Back Pain". 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 M...
What is the current status of trial NCT04468074?
This trial is currently completed. It is a NA study. The enrollment target is 72 participants. The study started on 2020-06-09. Estimated completion is 2021-06-14.
What interventions are being tested in trial NCT04468074?
The interventions under investigation include: Virtual Reality Therapy for Chronic Pain (DEVICE).
Who is sponsoring clinical trial NCT04468074?
This trial is sponsored by CognifiSense, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04468074's enrollment target sits among peer trials
72 1089th of 2000 higher than 899 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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