Virtual Reality Therapy for Chronic Low Back Pain
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- STATUS
- Recruiting
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- End date
- Dec 30, 2023
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- participants needed
- 360
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- sponsor
- Cedars-Sinai Medical Center
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.
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.
Details
| Condition | Chronic Lower Back Pain |
|---|---|
| Treatment | PICO G2 4k |
| Clinical Study Identifier | NCT04409353 |
| Sponsor | Cedars-Sinai Medical Center |
| Last Modified on | 21 April 2022 |
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