EaseVRx-8w+ for the Treatment of Chronic Lower Back Pain

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Chronic Low-back Pain, Anxiety, Depression

In brief

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.

Key facts

Study ID

NCT05263037

Run by

AppliedVR Inc.

People needed

1093

Starts

2022-01-31

Expected to finish

2026-06-01

Last updated by the study team

2025-01-29

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• AppliedVR — Van Nuys, California, United States

Full record on ClinicalTrials.gov

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