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 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT02697435
Eligibility Criteria:
Inclusion Criteria:
* English-speaking (to ensure the validity of data collected)
* Age 60 and older
* Lumbar MRI within past 30 days and is without evidence of infection, malignancy, or acute fracture OR scheduled for a lumbar MRI within the next 30 days
* CLBP, defined as pain in the lower back of at least moderate severity (assessed with a verbal rating scale), every day or almost every day, for at least 3 months
* No red flags that would indicate a serious underlying disorder that would necessitate urgent and specialized treatment, i.e.,
* weight loss
* fever
* sudden severe LBP
* change in bowels/bladder
* back pain that awakens from sleep
* recent leg weakness
* No pain in other body locations that is more severe than their low back pain
* No psychotic symptoms
* No previous spine surgery
* No dementia (Folstein Mini-Mental State Examination score of \> 24)
* No acute illness
* No prohibitive communication impairment (e.g., severe hearing or visual impairment)
* Able to commit to 6 months of study participation
Exclusion Criteria:
* Vulnerable subjects will not be enrolled
* Neither pregnant subjects nor women of childbearing potential will be included because the investigators are targeting older Veterans with CLBP
* Neither children nor prisoners will be included
* Incompetent subjects will be excluded from participating in this research, as determined by performance on the Folstein Mini Mental State Examination
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
89 Years
Study:
NCT02697435
Study Brief:
Protocol Section:
NCT02697435