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NCT04409353 · ClinicalTrials.gov registry record · NA
Virtual Reality Therapy for Chronic Low Back Pain
A NA study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 413
- Enrollment target
NCT04409353: Completed NA study, sponsored by Cedars-Sinai Medical Center.
NCT04409353 is a NA study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 413 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04409353, a NA study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 413 participants
- Enrollment target
Study Summary
This study will test the efficacy of an evidence-based virtual reality (VR) therapy program as a non-pharmacological supplement for the management of chronic lower back pain. Study participants will be randomized to receive one of three VR programs: Skills-Based VR, Distraction VR, or Sham VR. In addition to a VR headset, all participants will receive a Fitbit Charge 4 watch. Study devices will be delivered to the participant's home with instructions for use via FedEx; participants will receive remote technical support. They will be followed for 90 days and complete Patient Reported Outcome (PRO) questionnaires to assess functional status, pain levels, and use of pain medications (including opioids). Participants will also be asked to provide consent/authorization to access medical records from their treating facility.
Primary Outcome
The primary outcome for this study will be self-reported pain interference using Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) version 8a. The pain interference scale measures the consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Items are rated on a 5-point Likert scale from "not at all" (1) to "very much" (5) with a
Interventions
- DEVICE Sham VR
- DEVICE Activity Tracker
- DEVICE Skills-Based VR
- DEVICE Distraction-Based VR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 413 participants |
| Start Date | 2020-09-21 |
| Est. Completion | 2024-02-01 |
| Phase | NA |
What the finished NCT04409353 record still lists
NCT04409353 is an interventional study that assigns participants to a tested intervention. The registered 413 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 4 interventions - of which Sham VR is the first listed.
NCT04409353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04409353 about?
NCT04409353 is a clinical study titled "Virtual Reality Therapy for Chronic Low Back Pain". This study will test the efficacy of an evidence-based virtual reality (VR) therapy program as a non-pharmacological supplement for the management of chronic lower back pain. Study participants will be randomized to receive one of three VR programs: Skills-Based VR, Distraction VR, or Sham VR. In ad...
What is the current status of trial NCT04409353?
This trial is currently completed. It is a NA study. The enrollment target is 413 participants. The study started on 2020-09-21. Estimated completion is 2024-02-01.
What interventions are being tested in trial NCT04409353?
The interventions under investigation include: Sham VR (DEVICE), Activity Tracker (DEVICE), Skills-Based VR (DEVICE), Distraction-Based VR (DEVICE).
Who is sponsoring clinical trial NCT04409353?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04409353's enrollment target sits among peer trials
413 241st of 2000 higher than 1,760 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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