Chronic Back Pain, Chronic Lower Back Pain (CLBP), Chronic Pain
Conditions
Keywords
chronic pain relief, back pain, chronic back pain, chronic lower back pain
Brief summary
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.
Interventions
DEVICESkills-based Virtual Reality Therapy
1. A 34-minute education video session on the science behind chronic pain and the scientific principles of the therapy. 2. VR skills-based therapy: a virtual reality therapy consisting of different psychological training exercises
DEVICEDistraction-based Virtual Reality Therapy
1\. A 7-minute education video session on the science behind pain-focused attention and distraction. 2. VR distraction-based therapy: a virtual reality therapy that encourages passive attention and minimizes external cognitive demands.
Sponsors
CognifiSense Inc.
University of Colorado, Boulder
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity and Interference | Change from pre-treatment to post-treatment = 8 weeks | Brief Pain Inventory-short form (BPI-SF). Measured on a Scale of 0 to 10, 0 = no pain, 10 = worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Interference | Change from pre-treatment to post-treatment = 8 weeks | Brief Pain Inventory-short form (BPI-SF). Measured on a Scale of 0 to 10, 0 = no interference, 10 = severe interference. |
| Disability | Change from pre-treatment to post-treatment = 8 weeks | Oswestry Low Back Pain Disability Questionnaire (OLBPQ). Measured on a scale of 0-100%, 0-20% = minimal disability, 80-100% = patients are bed-bound or exaggerating symptoms. |
| Physical Function | Change from pre-treatment to post-treatment = 8 weeks | Physical Function (PROMIS). 5-point Likert scale: 5 = without any difficulty, 1 = unable to do (worse outcome). |
| Sleep Disturbance | Change from pre-treatment to post-treatment = 8 weeks | Sleep Disturbance (PROMIS). 5-point Likert scale: 1 = very good, 5 = very poor (worst outcome). |
| Depression | Change from pre-treatment to post-treatment = 8 weeks | Depression (PROMIS). 5-point Likert scale: 1 = never, 5 = always (worst outcome). |
| Anxiety | Change from pre-treatment to post-treatment = 8 weeks | Anxiety (PROMIS). 5-point Likert scale: 1 = never, 5 = always (worst outcome). |
| Fatigue | Change from pre-treatment to post-treatment = 8 weeks | Fatigue (PROMIS). 5-point Likert scale: 1 = not at all, 5 = very much (worst outcome). |
| Stress | Change from pre-treatment to post-treatment = 8 weeks | Perceived Stress Scale (PSS). Measured on a scale of 0 to 40, 0-13 = low stress, 27-40 = high perceived stress. |
Countries
United States
Outcome results
None listed