Status:
COMPLETED
Virtual Reality Treatment for Adults With Chronic Back Pain
Lead Sponsor:
CognifiSense Inc.
Collaborating Sponsors:
University of Colorado, Boulder
National Institute of Nursing Research (NINR)
Conditions:
Chronic Pain
Back Pain Lower Back Chronic
Eligibility:
All Genders
21-70 years
Phase:
NA
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 w...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2021
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04468074
Start Date
June 9 2020
End Date
June 14 2021
Last Update
June 23 2022
Active Locations (1)
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1
University of Colorado, Boulder
Boulder, Colorado, United States, 80301