Virtual Reality Treatment for Adults With Chronic Back Pain (VRNT)

CognifiSense

Status: Enrolling

Conditions: Chronic Back Pain; Chronic Lower Back Pain (CLBP); Chronic Pain

Treatments: Device: Skills-based Virtual Reality Therapy; Device: Distraction-based Virtual Reality Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07033195

24-0138

Details and patient eligibility

About

Participants with chronic back pain will complete an online Qualtrics eligibility survey. After signing a consent form, eligible participants enter a two-week baseline period ("Baseline Period"), during which they complete two assessments of the Primary and Secondary Outcome Measures and Potential Mediators. After the baseline period, participants are randomized into a Virtual Reality group: VR Distraction-based Therapy or VR Skills-based Therapy, with a 1:1 allocation ratio of participants to each treatment. Both groups receive education on pain neuroscience and complete training on the use of the VR hardware and software. Next, both groups complete an intervention for 8 weeks ("Treatment Period"), after which they return the VR equipment. Several surveys are administered online during the Treatment Period. After the Treatment Period, both groups complete three post-treatment surveys at weeks 8, 20, and 32.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women aged 18 to 85.
• Self-reported diagnosis of chronic low back pain without radicular symptoms.
• Chronic low back pain duration of 6 months or more, and pain at least half the days in the last 6 months.
• Lower back pain as primary chronic pain complaint (greater than pain in other bodily regions).
• Average pain intensity of 4 or more out of 10 for the past week (from BPI-SF).
• English fluency (8th grade level).
• Willing to comply with study procedures/restrictions.
• Access to Wi-Fi.
• Implicit de facto internet and computer literacy.

Exclusion criteria

• Applicants, who are pregnant, planning pregnancy, or breastfeeding
• Back pain associated with compensation / litigation within 1 year.
• Leg pain greater than back pain (suggests neuropathic pain; may be less responsive to psychological therapy).
• Chronic pain other than chronic back pain.
• Diagnoses of schizophrenia, multiple personality dissociative identity disorder.
• History of major depressive disorder not controlled with medication or other conditions that produce significant cognitive or emotional disability.
• History of substance abuse.
• Inability to undergo MRI (determined at screening; see XVI: Risks to Participants).
• Any clinically significant unstable medical abnormality or acute or chronic disease of cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonary disease), hepatic, or renal systems; including: history of cardiovascular disease or issues (e.g., recent heart attack), stroke; brain surgery, or brain tumor; Diabetes; cancer (last 12 months); diagnosis of a specific inflammatory disorder: rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus; polymyositis; or Cauda Equina syndrome.
• History of seizure disorder, epilepsy, convulsions, or increased intracranial pressure anytime except pediatric febrile seizures.
• History of vertigo, dizziness, susceptibility to motion sickness
• History of head injury within 6 months,
• Unexplained, unintended weight loss of 'â• 20 lbs in past year. Self-reported history of (digital) eye strain or computer vision syndrome. Unable or unwilling to meet study attendance requirements. MRI contraindications as determined by MRI safety screen (e.g., pregnancy, metal in body, claustrophobia, using the standard screen conducted by the MRI imaging facility).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Virtual Reality Neuropsychological Therapy

Experimental group

Description:

Participants start the treatment period with three introductory sessions: 1. A 34-minute pain education video that introduces the neuroscience of acute and chronic pain, drivers of pain chronification, pain triggers, and the scientific principles behind the VRNT. 2. A session to customize the VR experience to match the participant's experience using a display of a personalized 3-dimensional audiovisual representation of each patient's pain. 3. A training session on the use of the VR hardware. The participant will receive a workbook to guide them through each day's session. Participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes.

Treatment:

Device: Skills-based Virtual Reality Therapy

Virtual Reality Neuroscience Therapy

Active Comparator group

Description:

Participants start the treatment period with two introductory sessions: 1. A 7-minute pain education video that introduces the neuroscience of pain-focused attention, distraction, and the scientific principles behind VRNT. 2. A training session on the use of the VR hardware. The participant will receive a workbook (Attachment 'VRNT Workbook') to guide them through each day's session. Participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes.

Treatment:

Device: Distraction-based Virtual Reality Therapy