Virtual Reality Treatment for Adults With Chronic Back Pain

Study Overview
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Brief Summary
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Participants with chronic back pain will complete an online eligibility questionnaire. After signing a consent form, eligible participants enter a two-week baseline period (Baseline Period) during which they complete a daily pain survey. Following the Baseline Period all participants complete an MRI scan. After the MRI, scan participants are randomized into a treatment group (Therapy Group) or a no-intervention group (Standard of Care Group or SOC Group) with a ratio of 1:1 (treatment:SOC). Therapy Group participants receive education about chronic pain. They also participate in sessions to personalize their Virtual Reality (VR) experience, and to complete training on the use of the VR hardware and software. Therapy Group participants complete the treatment for 8 weeks (Therapy Period), after which they return the VR equipment. All participants take a second MRI scan approximately 8-weeks after the first MRI; for the Therapy Group this is at the end of the Therapy Period. After the Therapy Period, Therapy Group participants continue to complete daily pain surveys during a two-week follow-up period (Follow-Up Period). All participants complete self-reported clinical outcomes and behavioral measures surveys before and after the Baseline Period, 4 weeks after the first MRI (for Therapy Group this is mid-way through the Therapy Period), and before and after the Follow-Up Period. For Therapy Group participants the study ends with the final surveys and an exit interview at the end of the Follow-up Period. Study Extension (Add-on): SOC Group participants may receive the treatment after the Follow-Up period. Those who elect to do so will complete the same set of surveys as the Therapy Group did during the treatment phase; however, since there is no comparison group, data from this study extension is not used in the main outcomes analyses.

Official Title
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Study on the Use of Virtual Reality Neuropsychological Therapy Technology (VRNT) for Chronic Back Pain

Conditions
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Chronic Pain, Back Pain Lower Back Chronic, Back Pain

Intervention / Treatment
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* Device: Virtual Reality Therapy for Chronic Pain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants aged 21 to 70 with Chronic Back Pain. Chronic Back Pain will be defined according to criteria established by recent NIH task force. Pain duration must be ≥ 3 months, with back pain being an ongoing problem for at least half the days of last 6 months; i.e., either pain every day for past 3 months, or half or more of the days for past 6+ months. Subjects must rate pain intensity at ≥ 4/10 on Brief Pain Inventory (average pain over the last week). Participants must also be comfortable and able to communicate via email, text message, or phone in English. Participants must also be comfortable using a video-conferencing service such as Zoom to complete the on-line sessions. 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).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy Group<br>Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions: An education session on the science behind chronic pain and a basic overview of the VR therapy. A session to customize the VR experience to match the participant's own pain experience. A training session on the use of the VR hardware and software. Upon completion, participants begin using the VR therapy app at home once a day, 5 times a week (minimum), for a total of 8 weeks. The VR app contains different training exercises. A workbook provides a schedule and background on each of the training sessions. Therapy Group participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes. | Device: Virtual Reality Therapy for Chronic Pain<br>* A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises<br>* Other names: Virtual Reality Neuropsychological Therapy (VRNT);|
| No Intervention: Standard of Care (SOC) Group<br>The SOC Group (no-intervention) completes a daily pain survey. SOC Group participants are asked to maintain their pain treatment regimes, and are asked to notify the research team of any changes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Intensity and Interference. | Brief Pain Inventory-short form (BPI-SF). Measured on Scale of 0 to 10, 0 = no pain, 10 = worst pain imaginable. | Change from pre-treatment to post-treatment = 8 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life. | Quality of Life (HRQoL SF-12) Questionnaire: yes / no questions and 3-point / 6-point Likert Scale questions; e.g., 1 = [negative impact] all of the time (worse outcome), 6 = [negative impact] none of the time. HRQoL results in two sub-scales / components (Physical and Mental). The mean of these was taken to result in a single value. | Baseline (average of survey data at beginning and end of a 2-week baseline period) and at the end of the 8 week therapy / control period. | 
| Change in Back Pain Disability. | Oswestry Low Back Pain Disability Questionnaire (OLBPD). 6-point Likert Scale questions on impact of pain on various life aspects; e.g., 1 = no negative impact, 6 = prevents normal activity (worse outcome). Participants completed questionnaire at the beginning and end of a 2-week baseline period and at the end of the 8 week therapy / control period. The starting values were the average of the two reported pain measures at the beginning and end of the baseline period | Change from pre-treatment to post-treatment = 8 weeks. |