Virtual Reality Therapy for Chronic Low Back Pain

Status Completed

Clinical Trial Summary

This study will test the effectiveness of an evidence-based virtual reality therapy program as a non-pharmacological supplement to managing patients with pain due to chronic lower back pain. Outpatients will be randomized to receive one of three virtual reality (VR) programs: skills-based VR, distraction VR, or sham VR. All patients will receive a VR headset and Fitbit Charge 4 watch. Study devices will be delivered to the patient's home with instructions for use via FedEx; patients will receive remote technical support. Patients will be followed for 90 days and monitored for functional status, pain levels, use of pain medications (including opioids). Participants will also be asked to consent/authorization to access medical records from their treating facility.

Clinical Trial Description

This is a randomized double-blind, placebo-controlled trial for individuals with chronic lower back pain. This study investigates the effect of at-home virtual reality (VR) pain reduction therapy on a set of outcome measures. The primary outcome is Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference version 8. This study will enroll 360 participants into one of three VR therapy groups. Data collection will occur at home via personal computer or smartphone (iphone/android), with baseline data collected one week before the intervention is mailed to the patient. The patient will have the VR headset for 90 days. A post-study survey will be sent to patients 30 days after the end of the study. To learn more about the study and to assess your eligibility, please visit our study website at https://virtualmedicine.org/research/current/vr4backpain ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04409353
Study type	Interventional
Source	Cedars-Sinai Medical Center
Contact
Status	Completed
Phase	N/A
Start date	September 21, 2020
Completion date	February 1, 2024

View Details

See also
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