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NCT04933474 · ClinicalTrials.gov registry record · NA
Pragmatic Comparative Effectiveness Trial of Evidence-based, On-demand, Digital Behavioral Treatments for Chronic Pain
A NA study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 330
- Enrollment target
NCT04933474: Completed NA study, sponsored by Cedars-Sinai Medical Center.
NCT04933474 is a NA study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 330 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04933474, a NA study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 330 participants
- Enrollment target
Study Summary
This study compared two available, evidence-based, at-home digital pain treatment programs. The goal is to see if one approach is better than the other, and whether certain patients respond to one more than the other. Study participants will be randomly assigned to receive one of two treatment programs: Skills-Based VR or painTRAINER. VR devices and painTRAINER manuals 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 12 weeks 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
\[Alternative Title: Proportion of Participants with \>=2 Change in Average of 7 Daily Pain Intensity Questionnaires\] The change from study baseline to week 8 in daily pain intensity was measured using the standard 11-point numeric rating scale (NRS) with a 24-hour recall. Daily pain NRS was measured for 7-days during baseline and again during the final week of the study (week 8). This outcome is the baseline vs. week 8 difference-in-difference in 7-day average NRS pain intensity scores, dicho
Interventions
- BEHAVIORAL painTRAINER®
- DEVICE Skills-Based VR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2022-03-23 |
| Est. Completion | 2024-06-12 |
| Phase | NA |
What the finished NCT04933474 record still lists
NCT04933474 is an interventional study that assigns participants to a tested intervention. The registered 330 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 (76% lower).
The record links to 0 conditions, and to 2 interventions - of which painTRAINER® is the first listed.
NCT04933474 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04933474 about?
NCT04933474 is a clinical study titled "Pragmatic Comparative Effectiveness Trial of Evidence-based, On-demand, Digital Behavioral Treatments for Chronic Pain". This study compared two available, evidence-based, at-home digital pain treatment programs. The goal is to see if one approach is better than the other, and whether certain patients respond to one more than the other. Study participants will be randomly assigned to receive one of two treatment progr...
What is the current status of trial NCT04933474?
This trial is currently completed. It is a NA study. The enrollment target is 330 participants. The study started on 2022-03-23. Estimated completion is 2024-06-12.
What interventions are being tested in trial NCT04933474?
The interventions under investigation include: painTRAINER® (BEHAVIORAL), Skills-Based VR (DEVICE).
Who is sponsoring clinical trial NCT04933474?
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 NCT04933474's enrollment target sits among peer trials
330 307th of 2000 higher than 1,693 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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