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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT04129034
Eligibility Criteria:
Inclusion Criteria:
1. Adult male and females \>55 years of age legally able and willing to participate in the study and come for follow-up visits
2. Able and willing to fill the research questionnaires and to communicate with investigator and research team
3. Patient with bilateral or unilateral low back pain of \> 6 months duration
4. Patients whose back pain is alleviated by recumbency or comfortable sitting position
5. Patients presenting with a) a positive (\>70% pain relief) to a previous, single or double, L1 to L5 lumbar medial branch block (within the last 12 months) and / or b) with a positive (\>70% pain relief lasting more than 6 months) to a previous lumbar facet thermal radiofrequency denervation.
6. Average pain score of 6 or higher in the last month, (on 0-10 scale).
Exclusion Criteria:
1. Pregnant or breastfeeding patient
2. Patients younger than 55 or older than 85 years
3. Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).
4. Patients with history of lumbosacral spine surgery excluding previous lumbar radiofrequency neurotomy
5. Patients who have had lumbar radiofrequency neurotomy in the past 6 months
6. Patients with the presence of metal hardware or other foreign objects at the lumbosacral spine
7. Patients with history of lumbar spine pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event, (per the discretion of the study PI)
8. Patients unable to understand and complete the research questionnaires in the official language used within the particular sites' location.
9. Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome per PI decision.
10. Patient with extensive scarring of the skin and tissue overlying the treatment area.
11. Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project
12. Any patients with an uncontrolled coagulopathy
13. Patients with known osteoporosis with absolute risk of spinal fracture of \>10% over 10 years will be excluded
14. Any patients with a history of malignant disease in the past five years
15. Patients with rheumatologic diseases causing spine pain that are currently receiving active treatment including steroids, disease modifying drugs, biological agents or immunosuppressants.
16. Patients known for concomitant psychiatric disorders, excluding mood disorders.
17. Patients presenting with concomitant mood disorders (deemed severe by the research physician).
18. Patients with a first-degree family member already enrolled in this study.
19. Patient who is scheduled for any interventional/surgical procedure within 3 months from screening date
20. Patients diagnosed with co-morbid multifocal chronic pain (e.g., fibromyalgia)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
85 Years
Study:
NCT04129034
Study Brief:
Protocol Section:
NCT04129034