Virtual Reality Therapy for Chronic Low Back Pain

Cedars-Sinai Medical Center

Status

Completed

Conditions

Chronic Low Back Pain

Treatments

Device: Sham VR

Device: Activity Tracker

Device: Skills-Based VR

Device: Distraction-Based VR

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04409353

Pro00000631

1UG3AR076573-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will test the efficacy of an evidence-based virtual reality (VR) therapy program as a non-pharmacological supplement for the management of chronic lower back pain. Study participants will be randomized to receive one of three VR programs: Skills-Based VR, Distraction VR, or Sham VR. In addition to a VR headset, all participants will receive a Fitbit Charge 4 watch. Study devices will be delivered to the participant's home with instructions for use via FedEx; participants will receive remote technical support. They will be followed for 90 days and complete Patient Reported Outcome (PRO) questionnaires to assess functional status, pain levels, and use of pain medications (including opioids). Participants will also be asked to provide consent/authorization to access medical records from their treating facility.

Full 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 therapies 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 analyzable 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. Participants will have the VR headset for 90 days. Patients are also sent Fitbit smartwatches to track physical activity.

Enrollment

413 patients

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Able to provide consent to participate in research
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, age 13 or older
An ongoing low 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.
Ability to comprehend spoken and written English
Owns a compatible android or iOS smartphone, or personal laptop or desktop computer (excluding tablets) to complete surveys and has access to email.

Exclusion criteria

Presents with a condition that interferes with virtual reality usage, including history of seizure, facial injury precluding safe placement of headset, significant visual or hearing impairment that impacts ability to see the virtual reality images or follow audio instructions
Are being recommended for long-term hospitalization that would require more than three-week stay in the hospital
Received surgical procedure within the previous 8 weeks
Surgery is planned within the next 3 months
Is currently using a spinal cord stimulator
Has low back pain attributable to a recognizable, specific pathology, including spinal infection, cancer, fracture, or inflammatory spondylopathies, consistent with the NIH Task force on Research Standards for chronic low back pain
Previously participated in a virtual reality clinical trial

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

413 participants in 3 patient groups

Distraction-Based VR

Active Comparator group

Description:

EaseVRx-Distraction has the same number of experiences, the same approximate duration of experiences, and the identical user interface as EaseVRx+, with a linear prescribed sequence of experiences. The key differences are the lack of an on-demand library and that instead of offering a variety of VR experiences including education, games, and breath biofeedback, EaseVRx Distraction only includes 360-degree videos - which are also present in EaseVRx+. This is intended to remove the effect of education and skills-based training, while preserving the immersive experience of 360- degree VR.

Treatment:

Device: Distraction-Based VR

Device: Activity Tracker

Sham VR

Sham Comparator group

Description:

EaseVRx-Sham software includes 2D nature footage accompanied by neutral music that is selected to be neither relaxing nor distracting, rather than 360-degree, 3D, interactive content specially selected for efficacy. The experience of using EaseVRx-Sham is similar to watching a large-screen TV, but it is not interactive or immersive. EaseVRx Sham has the same number and duration of experiences as the EaseVRx+ linear prescribed sequence but does not contain an on-demand library; the functionality of the user interface used to access the experiences is otherwise the same as EaseVRx+. Modifications were made to the appearance of the user interface in order to remove aspects that were added for therapeutic benefit.

Treatment:

Device: Activity Tracker

Device: Sham VR

Skills-Based VR

Experimental group

Description:

EaseVRx+ incorporates the evidence-based principles of CBT, mindful meditation, and physiologic biofeedback therapy using embedded biometric sensors. It combines psychoeducation, pain education, breathing training, relaxation exercises, and executive functioning games to provide a mind-body approach toward living better with chronic pain. The standardized, prescriptive, and reproducible 56-day program delivers a combination of skills training and CBT-related treatments through scheduled daily virtual experiences. EaseVRx+ also features an on-demand library, allowing users to access any of the unique video sessions as needed.

Treatment:

Device: Skills-Based VR

Device: Activity Tracker

Trial documents