Clinical trial NCT04468074: Virtual Reality Treatment for Adults With Chronic Back Pain
Official title: Study on the Use of Virtual Reality Neuropsychological Therapy Technology (VRNT) for Chronic Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Back Pain Lower Back Chronic
Back Pain
Lead sponsor: CognifiSense Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Colorado, Boulder
name: National Institute of Nursing Research (NINR)
First posted: 2020-07-13
Enrollment: 72
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

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).

Primary outcomes:
measure: Change in Pain Intensity and Interference.
timeFrame: Change from pre-treatment to post-treatment = 8 weeks.
Secondary outcomes:
measure: Change in Quality of Life.
timeFrame: 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.
measure: Change in Back Pain Disability.
timeFrame: Change from pre-treatment to post-treatment = 8 weeks.
Other outcomes:
measure: Change in Pain Bothersomeness.
timeFrame: Change from pre-treatment to post-treatment = 8 weeks.
measure: Change in Medications and Therapies.
timeFrame: Change from pre-treatment to post-treatment = 8 weeks.
measure: Change in Pain Catastrophizing.
timeFrame: Change from pre-treatment to post-treatment = 8 weeks.
measure: Change in Fear of Pain.
timeFrame: Change from pre-treatment to post-treatment = 8 weeks.
measure: Change in Fear of Movement.
timeFrame: Change from pre-treatment to post-treatment = 8 weeks.
measure: Change in Sleep Quality.
timeFrame: Change from pre-treatment to post-treatment = 8 weeks.
measure: Change in Fatigue Symptoms.
timeFrame: Change from pre-treatment to post-treatment = 8 weeks.
measure: Change in Depression.
timeFrame: Change from pre-treatment to post-treatment = 8 weeks.
measure: Change in Pain Attitudes.
timeFrame: Change from pre-treatment to post-treatment = 8 weeks.
measure: Change in Self-efficacy.
timeFrame: Change from pre-treatment to post-treatment = 8 weeks.
measure: Expectations of Treatment Success.
timeFrame: Before Therapy Period begins (pre-treatment; after 2-week baseline).
measure: Impression of Treatment Success.
timeFrame: At the end of the Therapy Period (post-treatment; approx. 10 weeks into study).
measure: Change in Optimism
timeFrame: Change from pre-treatment to post-treatment = 8 weeks.
measure: Change in Emotion Regulation.
timeFrame: Change from pre-treatment to post-treatment = 8 weeks.
measure: Change in Mindfulness.
timeFrame: Change from pre-treatment to post-treatment = 8 weeks.
measure: Change in Pain Coping Strategies.
timeFrame: Change from pre-treatment to post-treatment = 8 weeks.
measure: Change in Structural (Brain) MRI.
timeFrame: Change from pre-treatment to post-treatment = 8 weeks.
measure: Change in Resting-State Functional MRI.
timeFrame: from pre-treatment to post-treatment = 8 weeks.
measure: Change in Diffusion Tensor Imaging (DTI) MRI.
timeFrame: Change from pre-treatment to post-treatment = 8 weeks.
measure: Assessment of Usability of VR Device.
timeFrame: At the end of the Therapy Period (post-treatment; approx. 10 weeks into study).
measure: Assessment of Sense of Presence in the VR Environment.
timeFrame: At the end of the Therapy Period (post-treatment; approx. 10 weeks into study).
measure: Assessment of Sense of Embodiment in the VR Environment.
timeFrame: At the end of the Therapy Period (post-treatment; approx. 10 weeks into study)
Locations:
city: Boulder
country: United States
facility: University of Colorado, Boulder
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: Marta Ceko, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CognifiSense Inc.
name: Lynn Webster, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CognifiSense Inc.
name: Tassilo Baeuerle
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.