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Development and Validation of a Digital Pain-Reduction Kit for Musculoskeletal Injuries

Pain, Acute Clinical Trial

Official title:
Development and Validation of a Digital Pain-Reduction Kit for Musculoskeletal Injuries

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03187132
Study type Interventional
Source Cedars-Sinai Medical Center
Contact
Status Completed
Phase N/A
Start date April 3, 2018
Completion date May 20, 2020
View Details
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