Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain

Launched by FUSMOBILE INC. · Dec 10, 2021

Keywords

ClinConnect Summary

Study design: Prospective, Double Arm Timeline: Twelve months enrollment period and 6 months follow-up period. Sites: The study will be conducted at 10 sites in the USA Study population: 80 adult subjects diagnosed with facet related low back pain with an additional 10 roll in subjects.

Arms: 40 patients would be treated by the NeurolyserXR and 40 would get a sham treatment Crossover: blinded crossover between the two arms could be done between 1 and 3 months Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of chronic low back pain secondary to zygapophys...

Gender

ALL

Eligibility criteria

• 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
• • 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