Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Colorado, Boulder | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Neuropsychological Therapy | Experimental | Participants start the treatment period with three introductory sessions:
Participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes. |
|
| Virtual Reality Neuroscience Therapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skills-based Virtual Reality Therapy | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity and Interference | Brief Pain Inventory-short form (BPI-SF). Measured on a Scale of 0 to 10, 0 = no pain, 10 = worst pain imaginable. | Change from pre-treatment to post-treatment = 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Interference | Brief Pain Inventory-short form (BPI-SF). Measured on a Scale of 0 to 10, 0 = no interference, 10 = severe interference. | Change from pre-treatment to post-treatment = 8 weeks |
| Disability |
| Measure | Description | Time Frame |
|---|---|---|
| Cybersickness | Single item questionnaire: "Did you experience any motion sickness or nausea while using VR?". 4-point Likert Scale: 0 = never, 3 = always (worst outcome). | Assessed at Week 8 |
| Global Improvement |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marta Ceko, Ph.D. | Contact | +1 443-835-6587 | Marta.Ceko@colorado.edu | |
| Amanda Way, MS | Contact | +1 4016597016 |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Boulder | Recruiting | Boulder | Colorado | 80309 | United States |
Not provided
| Label | URL |
|---|---|
| Landing Page for the study | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Distraction-based Virtual Reality Therapy | Device | 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. |
|
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.
| Change from pre-treatment to post-treatment = 8 weeks |
| Physical Function | Physical Function (PROMIS). 5-point Likert scale: 5 = without any difficulty, 1 = unable to do (worse outcome). | Change from pre-treatment to post-treatment = 8 weeks |
| Sleep Disturbance | Sleep Disturbance (PROMIS). 5-point Likert scale: 1 = very good, 5 = very poor (worst outcome). | Change from pre-treatment to post-treatment = 8 weeks |
| Depression | Depression (PROMIS). 5-point Likert scale: 1 = never, 5 = always (worst outcome). | Change from pre-treatment to post-treatment = 8 weeks |
| Anxiety | Anxiety (PROMIS). 5-point Likert scale: 1 = never, 5 = always (worst outcome). | Change from pre-treatment to post-treatment = 8 weeks |
| Fatigue | Fatigue (PROMIS). 5-point Likert scale: 1 = not at all, 5 = very much (worst outcome). | Change from pre-treatment to post-treatment = 8 weeks |
| Stress | Perceived Stress Scale (PSS). Measured on a scale of 0 to 40, 0-13 = low stress, 27-40 = high perceived stress. | Change from pre-treatment to post-treatment = 8 weeks |
Patient's Global Impression of Change (PGIC). 10-point Likert scale: 0 = much better, 10 = much worse (worst outcome).
| Assessed at Week 8 |
| Treatment Satisfaction | Treatment satisfaction (single item). 7-point Likert scale: extremely satisfied, extremely dissatisfied (worst outcome). | Assessed at Week 8 |
| System Usability | System usability (SUS). 5-point Likert scale: 1 = strongly disagree, 5 = strongly agree. | Assessed at Week 8 |
| Virtual Reality Device Use | Data collected from VR Device | Throughout treatment = 8 weeks |
| Chronic Pain Acceptance | Chronic Pain Acceptance Questionnaire (CPAQ-8). 7-point Likert scale: 6 = always true, 0 = never true (worst outcome). | Change from pre-treatment to post-treatment = 8 weeks |
| Pain catastrophizing | Pain catastrophizing (PCS). 5-point Likert scale: 0 = not at all, 4 = all the time (worst outcome). | Change from pre-treatment to post-treatment = 8 weeks |
| Pain self-efficacy | Pain Self-Efficacy Questionnaire (PSEQ-2). 7-point Likert scale: 6 - completely Confident, 0 = not at all confident (worst outcome). | Change from pre-treatment to post-treatment = 8 weeks |
| Positive and Negative affect | Positive and Negative Affect Schedule (PANAS-SF). 5-point Likert scale: 1 = very slightly, 5 = extremely. | Change from pre-treatment to post-treatment = 8 weeks |
| Fear of movement | Tampa Scale Kinesiophobia (TSK). 4-point Likert scale: 1 = strongly disagree, 4 - strongly agree (worst outcome). | Change from pre-treatment to post-treatment = 8 weeks |
| Immersive tendencies | Immersive Tendencies Questionnaire (ITQ). 7-point Likert scale: never, often. | Change from pre-treatment to post-treatment = 8 weeks |
| Expectations of treatment success | Expectations of Treatment Success. 10-point Likert scale: 10 = most, 0 = none. | Change from pre-treatment to post-treatment = 8 weeks |
| Adherence | Data collected from VR Device | Throughout treatment = 8 weeks |
| Medication Use | Custom analgesic medication use survey. Data collection of medication type, frequency of use, and dose standardized with "Opioid Oral Morphine Milligram Equivalent (MME) Conversion Table" | Change from pre-treatment to post-treatment = 8 weeks |