University of Colorado Boulder
Boulder, Colorado, 80309, United States
Location status: Recruiting
Location contact
Amanda Way, MS
CONTACT
Marta Ceko, ph.D.
CONTACT
Marta Ceko, ph.D.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07033195
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
Boulder, Colorado, 80309, United States
Location status: Recruiting
Amanda Way, MS
CONTACT
Marta Ceko, ph.D.
CONTACT
Marta Ceko, ph.D.
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Change from pre-treatment to post-treatment = 8 weeks
Sleep Disturbance (PROMIS). 5-point Likert scale: 1 = very good, 5 = very poor (worst outcome).
Time frame: Change from pre-treatment to post-treatment = 8 weeks
Depression (PROMIS). 5-point Likert scale: 1 = never, 5 = always (worst outcome).
Time frame: Change from pre-treatment to post-treatment = 8 weeks
Anxiety (PROMIS). 5-point Likert scale: 1 = never, 5 = always (worst outcome).
Time frame: Change from pre-treatment to post-treatment = 8 weeks
Fatigue (PROMIS). 5-point Likert scale: 1 = not at all, 5 = very much (worst outcome).
Time frame: 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.
Time frame: Assessed at Week 8
Single item questionnaire: "Did you experience any motion sickness or nausea while using VR?". 4-point Likert Scale: 0 = never, 3 = always (worst outcome).
Time frame: Assessed at Week 8
Patient's Global Impression of Change (PGIC). 10-point Likert scale: 0 = much better, 10 = much worse (worst outcome).
Time frame: Assessed at Week 8
Treatment satisfaction (single item). 7-point Likert scale: extremely satisfied, extremely dissatisfied (worst outcome).
Time frame: Assessed at Week 8
System usability (SUS). 5-point Likert scale: 1 = strongly disagree, 5 = strongly agree.
Time frame: Throughout treatment = 8 weeks
Data collected from VR Device
Time frame: Change from pre-treatment to post-treatment = 8 weeks
Chronic Pain Acceptance Questionnaire (CPAQ-8). 7-point Likert scale: 6 = always true, 0 = never true (worst outcome).
Time frame: Change from pre-treatment to post-treatment = 8 weeks
Pain catastrophizing (PCS). 5-point Likert scale: 0 = not at all, 4 = all the time (worst outcome).
Time frame: Change from pre-treatment to post-treatment = 8 weeks
Pain Self-Efficacy Questionnaire (PSEQ-2). 7-point Likert scale: 6 - completely Confident, 0 = not at all confident (worst outcome).
Time frame: Change from pre-treatment to post-treatment = 8 weeks
Positive and Negative Affect Schedule (PANAS-SF). 5-point Likert scale: 1 = very slightly, 5 = extremely.
Time frame: Change from pre-treatment to post-treatment = 8 weeks
Tampa Scale Kinesiophobia (TSK). 4-point Likert scale: 1 = strongly disagree, 4 - strongly agree (worst outcome).
Time frame: Change from pre-treatment to post-treatment = 8 weeks
Immersive Tendencies Questionnaire (ITQ). 7-point Likert scale: never, often.
Time frame: Change from pre-treatment to post-treatment = 8 weeks
Expectations of Treatment Success. 10-point Likert scale: 10 = most, 0 = none.
Time frame: Throughout treatment = 8 weeks
Data collected from VR Device
Time frame: Change from pre-treatment to post-treatment = 8 weeks
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"
Contact information is provided by the study sponsor or research team.
CognifiSense Inc.
Industry
Efficacy of a Virtual Reality Neuroscience-based Therapy (VRNT) for Chronic Low Back Pain
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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