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NCT03187132 · ClinicalTrials.gov registry record · NA
Development and Validation of a Digital Pain-Reduction Kit for Musculoskeletal Injuries
A NA study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 245
- Enrollment target
NCT03187132: Completed NA study, sponsored by Cedars-Sinai Medical Center.
NCT03187132 is a NA study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 245 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03187132, a NA study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 245 participants
- Enrollment target
Study Summary
This study will test the effectiveness of an evidence-based, multi-modal, "digital pain-reduction kit" as a non-pharmacological supplement to managing patients with pain due to musculoskeletal injuries. Outpatients will be randomized to receive either the pain reduction kit or active control. The kit will contain a virtual reality (VR) headset, therapeutic VR visualization software, and a low-cost wearable transcutaneous electrical nerve stimulation (TENS) unit. Clinical staff will monitor progress and provide scheduled coaching and outreach to patients in the intervention group. The control group will receive the low-cost wearable transcutaneous electrical nerve stimulation (TENS) unit alone; they will not receive VR or remote coaching. Study devices will be delivered to the patient's home with instructions for use; patients will receive remote clinical and technical support. Patients will be followed for 60 days and monitored for functional status, pain levels, use of pain medications (including opioids), satisfaction with care, and time to returning to work.
Primary Outcome
PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. A single Physical Function capability score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Physical Function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
Interventions
- DEVICE Digital Pain Reduction Kit
- DEVICE Active Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2018-04-03 |
| Est. Completion | 2020-05-20 |
| Phase | NA |
What the finished NCT03187132 record still lists
NCT03187132 is an interventional study that assigns participants to a tested intervention. The registered 245 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 (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Digital Pain Reduction Kit is the first listed.
NCT03187132 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03187132 about?
NCT03187132 is a clinical study titled "Development and Validation of a Digital Pain-Reduction Kit for Musculoskeletal Injuries". This study will test the effectiveness of an evidence-based, multi-modal, "digital pain-reduction kit" as a non-pharmacological supplement to managing patients with pain due to musculoskeletal injuries. Outpatients will be randomized to receive either the pain reduction kit or active control. The ki...
What is the current status of trial NCT03187132?
This trial is currently completed. It is a NA study. The enrollment target is 245 participants. The study started on 2018-04-03. Estimated completion is 2020-05-20.
What interventions are being tested in trial NCT03187132?
The interventions under investigation include: Digital Pain Reduction Kit (DEVICE), Active Control (DEVICE).
Who is sponsoring clinical trial NCT03187132?
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 NCT03187132's enrollment target sits among peer trials
245 436th of 2000 higher than 1,563 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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