NCT03187132

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Acute
• Pain, Chronic

Interventions

Type	Name	Description
DEVICE	Digital Pain Reduction Kit	A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain.
DEVICE	Active Control	An active control TENS unit used to reduce acute localized pain.

Timeline

• Start date: 2018-04-03
• Primary completion: 2020-05-20
• Completion: 2020-05-20
• First posted: 2017-06-14
• Last updated: 2021-08-05
• Results posted: 2021-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study