Chronic PainNCT07033195
Virtual Reality Treatment for Adults With Chronic Back Pain (VRNT)
A study testing Skills-based Virtual Reality Therapy and Distraction-based Virtual Reality Therapy in people with Chronic Pain and Chronic Back Pain, run by CognifiSense Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Pain, Chronic Back Pain, Chronic Lower Back Pain (CLBP)
- What is being tested?
- Skills-based Virtual Reality Therapy and Distraction-based Virtual Reality Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 20 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- Willing to comply with study procedures/restrictions.
- Access to Wi-Fi.
- Implicit de facto internet and computer literacy.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Boulder
Boulder, Colorado, 80309
About this study
Official title: Efficacy of a Virtual Reality Neuroscience-based Therapy (VRNT) for Chronic Low Back Pain
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.
- Being tested
- Skills-based Virtual Reality Therapy, Distraction-based Virtual Reality Therapy
- Keywords
- chronic pain relief, back pain, chronic back pain, chronic lower back pain
- Medical subject headings
- Chronic Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skills-based Virtual Reality TherapyDevice
- A 34-minute education video session on the science behind chronic pain and the scientific principles of the therapy.
- VR skills-based therapy: a virtual reality therapy consisting of different psychological training exercises
Distraction-based Virtual Reality TherapyDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Neuropsychological Therapy | Experimental | 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. Receives: Device: Skills-based Virtual Reality Therapy |
| 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. Receives: Device: Distraction-based Virtual Reality Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from pre-treatment to post-treatment = 8 weeks
Secondary outcomes (8)
Pain Interference
Brief Pain Inventory-short form (BPI-SF). Measured on a Scale of 0 to 10, 0 = no interference, 10 = severe interference.
Measured: Change from pre-treatment to post-treatment = 8 weeks
Disability
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.
Measured: 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).
Measured: 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).
Measured: Change from pre-treatment to post-treatment = 8 weeks
Depression
Depression (PROMIS). 5-point Likert scale: 1 = never, 5 = always (worst outcome).
Measured: Change from pre-treatment to post-treatment = 8 weeks
Anxiety
Anxiety (PROMIS). 5-point Likert scale: 1 = never, 5 = always (worst outcome).
Measured: 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).
Measured: 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.
Measured: Change from pre-treatment to post-treatment = 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Jun 2025
- Primary completion20 Feb 2027 (estimated)
- Study completion20 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CognifiSense Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Colorado, Boulder
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033195
- Sponsor's protocol ID
- 24-0138
- Status last verified
- Aug 2026
- First submitted
- 6 Jun 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Virtual Reality Neuroscience-based Therapy (VRNT) for Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07033195
- Acronym / sponsor ID
- 24-0138
- Keywords
- chronic pain relief, back pain, chronic back pain, chronic lower back pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CognifiSense Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Colorado, Boulder
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Neuropsychological Therapy | Experimental | Device: Skills-based Virtual Reality TherapyParticipants 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. |
| Virtual Reality Neuroscience Therapy | Active comparator | Device: Distraction-based Virtual Reality TherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skills-based Virtual Reality Therapy1. 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 | Device | Virtual Reality Neuropsychological Therapy |
| Distraction-based Virtual Reality Therapy1. 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. | Device | Virtual Reality Neuroscience Therapy |
Primary outcome
Change in Pain Intensity and Interference
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.
8 secondary outcomes
Pain Interference
Time frame: Change from pre-treatment to post-treatment = 8 weeks
Disability
Time frame: Change from pre-treatment to post-treatment = 8 weeks
Physical Function
Time frame: Change from pre-treatment to post-treatment = 8 weeks
Sleep Disturbance
Time frame: Change from pre-treatment to post-treatment = 8 weeks
Depression
Time frame: Change from pre-treatment to post-treatment = 8 weeks
Anxiety
Time frame: Change from pre-treatment to post-treatment = 8 weeks
Fatigue
Time frame: Change from pre-treatment to post-treatment = 8 weeks
Stress
Time frame: Change from pre-treatment to post-treatment = 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Landing Page for the studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skills-based Virtual Reality Therapy and Distraction-based Virtual Reality Therapy in people with Chronic Pain and Chronic Back Pain, run by CognifiSense Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity and Interference (time frame: Change from pre-treatment to post-treatment = 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.