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:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT02932020
Eligibility Criteria:
Inclusion Criteria:
1. Low back pain of \> 4-5 weeks but \< 6-7 months
2. Evidence of at least mild lumbar stenosis /disc herniation on MRI
3. Failure of conservative therapy to include physical therapy and pharmacotherapy
4. Patient is at least 18 years of age
5. Patient is willing to be blinded to treatment until after the 12 week post injection visit
6. Patient is willing and able to review and sign the study informed consent form
Exclusion Criteria:
1\. No evidence of lumbar stenosis or disc herniation on MRI 2. Patient has had prior lumbar surgery at any level 3. Patient has received epidural steroid injection in the past 6 months 4. Patient currently receives systemic steroids for another medical condition 5. Patient is pregnant 6. Patient has systemic infection at the proposed injection site 7. Patient has a systemic malignancy 8. Current therapy with any immunosuppressive medication 9. History of solid organ or hematologic transplantation 10 History of autoimmune disorder 11. Patient has known allergy to lidocaine, marcaine or steroid 12. Devices and conditions that are contraindications for MRI examination (routinely screened before all MRI examinations).
13\. Patient is on anticoagulant medications (other than ASA). 14. Patient has eGFR of \<40 15. Patient has known chronic kidney disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02932020
Study Brief:
Protocol Section:
NCT02932020