The aim of this randomized controlled trial (RCT) is to assess outcomes for virtual reality therapy (including pain intensity, pain interference, anxiety, depression, physical function, sleep, behavioral skills development, health outcomes and satisfaction) along with healthcare utilization and costs in participants with Chronic Low Back Pain.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
* Male and female adults aged 18-85.
* Self-reported chronic low back pain that will be confirmed with claims data when available.
* Pain duration of at least three months.
* Average pain intensity score of ≥ 4 and average pain interference score of ≥ 4 on the 0-10 Brief Pain Inventory (BPI) Pain Scale for the past month at screening.
* Fluency in English.
* Willing and able to comply with all study procedures including all required restrictions for the duration of study participation.
* Able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study.
* Access to Internet for the duration of their study participation (24 months).
* Access to a smartphone or computer for the duration of the study.
* Availability of a physical mailing address that is not a PO box address for receipt of the device.
* Completed the Baseline Survey plus at least two of the five sets of participant surveys that are administered during the 10-day pretreatment assessment period.
* Able to provide photo ID
Exclusion Criteria:
* Unable to understand the goals of the study due to cognitive difficulty.
* Any medical condition that may prevent the use of virtual reality (e.g., current, or prior diagnosis of epilepsy, seizure disorder, hypersensitivity to flashing light or motion, migraines, any medical condition predisposing participant to nausea or dizziness, dementia, absence of stereoscopic vision or severe hearing impairment).
* Injury to eyes, face, or neck that prevents comfortable use of VR.
* Index back pain is linked to a cancer-related diagnosis.
* Possible suicidal ideation as indicated by the 9th item of the Participant Health Questionnaire-9 (PHQ-9).
* Previous participation in the 2020 AVR EaseVRx pivotal study.
* Receiving worker's compensation and/or involved in any active litigation related to an injury.
* Current or recent participation (i.e., within the last 2 months) in any other research study involving a drug, device, vaccine, or other interventional treatment product; or plans to participate in another research study over the next 24 months.
* Participation of two or more members in one household
* Recent or future medical procedures scheduled related to any current diagnosis
Primary outcome measure(s)
Brief Pain Inventory (BPI) Pain Intensity Questionnaire — Day 56 (end of treatment) The BPI pain intensity questionnaire is a validated instrument with good content validity, construct validity, and reliability in participants with chronic pain. The range of scores are from 0-10 with higher values implying greater pain intensity. The BPI pain intensity measure contains a single item related to pain intensity
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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