Status:
ACTIVE_NOT_RECRUITING
EaseVRx-8w+ for the Treatment of Chronic Lower Back Pain
Lead Sponsor:
AppliedVR Inc.
Conditions:
Chronic Low-back Pain
Anxiety
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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, behavio...
Detailed Description
This is a decentralized, randomized controlled trial with four parallel study arms comparing change from pre-treatment to end-of-treatment to 12-months posttreatment in the EaseVRx-8w, EaseVRx-8w plus...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
1093 Patients enrolled
Trial Details
Trial ID
NCT05263037
Start Date
January 31 2022
End Date
June 1 2026
Last Update
January 29 2025
Active Locations (1)
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1
AppliedVR
Van Nuys, California, United States, 91406