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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 is a NA study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 413 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04409353
The ClinicalTrials.gov registry entry for NCT04409353 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 413 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Sham VR is the first listed.
NCT04409353 reports 0 study locations.
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.
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