Virtual Reality Therapy for Chronic Low Back Pain

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    360
  • sponsor
    Cedars-Sinai Medical Center
Updated on 21 April 2022
analgesics
opioid
low back pain

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 IdentifierNCT04409353
SponsorCedars-Sinai Medical Center
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, above the age of 13
A back pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months
English speaking
The participant has either a personal computer or a smartphone (android/iphone) to the web-based complete surveys

Exclusion Criteria

Are presenting with a condition that interferes with virtual reality usage (e.g., history of seizure, facial injury precluding safe placement of headset, visual impairment, significant hearing impairment impact ability to follow audio instructions)
Are being recommended for long-term hospitalization that would require more than three-week stay inside the hospital
Received recent surgery within the previous 8 weeks
Any planned surgeries in the next 3 months
Are currently using a spinal cord stimulator
Have lower back pain attributable to a recognizable, specific pathology, such as infection, tumor, fracture, or inflammatory spondylopathy
Previously participated in a virtual reality clinical trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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