Ignite Creation Date:
2024-05-06 @ 2:42 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04409353
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2020-05-14
Brief Title:
Virtual Reality Therapy for Chronic Low Back Pain
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
Randomized-controlled Trial of Virtual Reality for Chronic Low Back Pain to Improve Patient-reported Outcomes and Physical Activity
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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 consentauthorization to access medical records from their treating facility
Detailed 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 iphoneandroid 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 httpsvirtualmedicineorgresearchcurrentvr4backpain
To learn more about the study and to assess your eligibility please visit our study website at httpsvirtualmedicineorgresearchcurrentvr4backpain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1UG3AR076573-01 | NIH | None | httpsreporternihgovquickSearch1UG3AR076573-01 |