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 @ 12:03 PM
Ignite Modification Date:
2025-12-24 @ 12:03 PM
NCT ID:
NCT03246061
Eligibility Criteria:
Inclusion Criteria:
* Skeletally mature subjects at least 25 years of age
* Chronic lower back pain for at least 6 months
* Failure to respond to at least 6 months of non-operative conservative management
Exclusion Criteria:
* Radicular pain
* Current or history of spinal infection
* Modic changes at vertebral bodies other than L3 to S1
* Contraindication to MRI
* Pregnant, lactating or plan to become pregnant in next year
* Has life expectancy of less than 2 years
* Compensated injuries or ongoing litigation regarding back pain/injury, or financial incentive to remain impaired
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
70 Years
Study:
NCT03246061
Study Brief:
Protocol Section:
NCT03246061