Clinical Trials

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:

1. Individuals who are pregnant or breastfeeding.

2. Individuals younger than 50 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 or any
individuals with clinical history suggestive of new/previously unknown malignancy and
pathological pain who require further work up or is currently undergoing work up.

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 individuals with clinical or radiographic evidence of dynamic instability of the
lumbar spine.

Eligibility last updated 6/10/22. Questions regarding updates should be directed to the study team contact.