Chronic PainNCT04468074

Virtual Reality Treatment for Adults With Chronic Back Pain

A study testing Virtual Reality Therapy for Chronic Pain in people with Chronic Pain and Back Pain Lower Back Chronic, run by CognifiSense Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 70 years
Conditions the study is for: Chronic Pain, Back Pain Lower Back Chronic, Back Pain
What is being tested?: Virtual Reality Therapy for Chronic Pain
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteUnited States
Study dates: 9 Jun 2020to 14 Jun 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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.

Show all 16Show fewer

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, 80301

Other trials in United States

About this study

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

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.

Conditions: Chronic Pain, Back Pain Lower Back Chronic, Back Pain
Being tested: Virtual Reality Therapy for Chronic 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.

Virtual Reality Therapy for Chronic PainDevice
Also called Virtual Reality Neuropsychological Therapy (VRNT)
1. A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy
2. Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises

Study groups in NCT04468074
Study group	Role	What they receive
Therapy Group	Experimental	Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions: 1. An education session on the science behind chronic pain and a basic overview of the VR therapy. 2. A session to customize the VR experience to match the participant's own pain experience. 3. 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. Receives: Device: Virtual Reality Therapy for Chronic Pain
Standard of Care (SOC) Group	No intervention	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 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 Scale of 0 to 10, 0 = no pain, 10 = worst pain imaginable.
Measured: Change from pre-treatment to post-treatment = 8 weeks.

Secondary outcomes (2)

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.
Measured: 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
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.

9 Jun 202014 Jun 2021

First posted13 Jul 2020
Study start9 Jun 2020
Primary completion13 Apr 2021
Study completion14 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
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: Outcomes assessor
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04468074
Sponsor's protocol ID: 19-0526
Other IDs: 1R43NR017575-01A1
Status last verified: May 2022
First submitted: 30 Jun 2020
Last updated: 23 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.
PubMed 27002445
Ceko M, Baeuerle T, Webster L, Wager TD, Lumley MA. The effects of virtual reality neuroscience-based therapy on clinical and neuroimaging outcomes in patients with chronic back pain: a randomized clinical trial. Pain. 2024 Aug 1;165(8):1860-1874. doi: 10.1097/j.pain.0000000000003198. Epub 2024 Mar 8.
PubMed 38466872

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study on the Use of Virtual Reality Neuropsychological Therapy Technology (VRNT) for Chronic Back Pain
ClinicalTrials.gov ID: NCT04468074
Acronym / sponsor ID: 19-0526
Conditions: Chronic Pain, Back Pain Lower Back Chronic, Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: CognifiSense Inc.Industry (pharma, biotech, devices)
Collaborators: University of Colorado, Boulder, National Institute of Nursing Research (NINR)
Study start: 9 Jun 2020 (actual)
Primary completion: 13 Apr 2021 (actual)
Study completion: 14 Jun 2021 (actual)
First posted: 13 Jul 2020 (actual)
Results: Posted 23 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Therapy Group	Experimental	Device: Virtual Reality Therapy for Chronic PainTherapy Group participants start the treatment period with three 1 ½ hour introductory sessions: 1. An education session on the science behind chronic pain and a basic overview of the VR therapy. 2. A session to customize the VR experience to match the participant's own pain experience. 3. 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.
Standard of Care (SOC) Group	No intervention	–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.

Who may qualify

Ages: 21 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (16 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
Virtual Reality Therapy for Chronic PainAlso: Virtual Reality Neuropsychological Therapy (VRNT)1. A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy 2. Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises	Device	Therapy Group

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 Scale of 0 to 10, 0 = no pain, 10 = worst pain imaginable.

2 secondary outcomes

Change in Quality of Life.
Time frame: 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.
Time frame: Change from pre-treatment to post-treatment = 8 weeks.

Results and safety

Results posted to the registry on 23 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Therapy Group	31	30
Standard of Care (SOC) Group	30	30

Primary outcome: Change in Pain Intensity and Interference.

Time frame: Change from pre-treatment to post-treatment = 8 weeks.. Mean (Standard Deviation). Unit: units on a scale

Measure	Therapy Group n = 30	Standard of Care (SOC) Group n = 30
Value	-1.5 (1.7)	-0.5 (1.3)

Therapy Group vs Standard of Care (SOC) Group: Mean Difference (Net): 1, p = 0.014, Mixed Models Analysis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Therapy Group	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Standard of Care (SOC) Group	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27002445Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.
Derived from this study: PubMed 38466872Ceko M, Baeuerle T, Webster L, Wager TD, Lumley MA. The effects of virtual reality neuroscience-based therapy on clinical and neuroimaging outcomes in patients with chronic back pain: a randomized clinical trial. Pain. 2024 Aug 1;165(8):1860-1874. doi: 10.1097/j.pain.0000000000003198. Epub 2024 Mar 8.

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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.

Marta Ceko, Ph.D. principal investigator

University of Colorado, Boulder

Lynn Webster, MD principal investigator

CognifiSense Inc.

Tassilo Baeuerle principal investigator

CognifiSense Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality Therapy for Chronic Pain in people with Chronic Pain and Back Pain Lower Back Chronic, 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 4 inclusion and 16 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: finished, as of the sponsor's last update on 23 Jun 2022. 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?

Yes. Results are posted in the registry (first posted 23 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

On the ClinicalTrials.gov record for NCT04468074, which also lists 2 linked publications.

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 23 Jun 2022.