Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-24 @ 1:14 PM
NCT ID:
NCT07033195
Eligibility Criteria:
Inclusion Criteria:
* 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).
* Willing to comply with study procedures/restrictions.
* Access to Wi-Fi.
* Implicit de facto internet and computer literacy.
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT07033195
Study Brief:
Protocol Section:
NCT07033195