Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
1. Age 50 to 85 years old, legally able and willing to participate in the study and all follow-up visits.
2. Able and willing to complete the research questionnaires and to communicate with investigator and research team.
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3. Individual with current bilateral or unilateral low back pain of > 6 months duration
4. Individual whose back pain is alleviated by recumbency or comfortable sitting position.
5. Individual presenting with a) a positive (> 80% pain relief) to a previous, double, lumbar medial branch block (within the last 12 months) and/or b) with a positive (> 70% pain relief lasting more than 6 months) to the most recent lumbar facet thermal radiofrequency denervation.
6. Average low back pain score of 6 or higher in the last month (on 0-10 scale) with activity.
Exclusion Criteria:
Individuals meeting ANY of the following criteria are Not Eligible for participation in this study:
1. Individuals who are pregnant or breastfeeding.
2. Individuals younger than 45 or older than 85 years.
3. BMI greater than 40, or individuals with at least one of the planned targets outside the Neurolyser XR treatment envelope as seen on treatment day on a lateral X-ray scan taken before the treatment.
4. Individuals presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).
5. Individuals with history of lumbar or lumbosacral spine surgery.
6. Individuals who have had lumbar radiofrequency neurotomy in the past 6 months.
7. Individuals with history of lumbar spine pathology that may increase procedural risk and/or influence symptoms and/or generate unrelated adverse event (per investigator’s discretion).
8. Individuals presenting with any severe medical condition preventing them from participation (per investigator’s discretion) (Example: inability to lay prone).
9. Individuals with extensive scarring of the skin and tissue overlying the treatment area.
10. Individuals enrolled in or planned to be enrolled in another clinical trial during the duration of this research project.
11. Any Individuals with an uncontrolled coagulopathy.
12. Individuals with known osteoporosis with absolute risk of spinal fracture of > 10% over 10 years.
13. Any Individuals with a history of malignant disease in the past five years.
14. Individuals with rheumatologic diseases causing spine pain that are currently receiving active treatment including steroids, disease modifying drugs, biological agents or immunosuppressants.
15. Individuals known for concomitant psychiatric disorders, excluding compensated mood disorders.
16. Individuals with first-degree family member already enrolled in this study.
17. Individual who is scheduled for any interventional/ surgical procedure within 6 months from the treatment date excluding trivial surgeries (e.g., cataract, carpal tunnel release).
18. Individuals diagnosed with co-morbid multifocal chronic pain (e.g., fibromyalgia, generalized osteoarthritis).
19. Individuals with other chronic pain that is 2 or more points higher on the NRS score than the participants low back pain.
20. Individuals who have had a steroid injection within the last 2 months from date of enrollment at the location of the planned treatment.
21. Any individual with a history of substance abuse per the PI discretion.
22. Any individual with a current open legal case related to the individual's, worker’s compensation claim.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 9/7/23. Questions regarding updates should be directed to the study team contact.