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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 is a NA study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 245 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03187132
The ClinicalTrials.gov registry entry for NCT03187132 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 245 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 2 interventions - of which Digital Pain Reduction Kit is the first listed.
NCT03187132 reports 0 study locations.
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.
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