Facet Syndrome of Lumbar Spine
Conditions
Keywords
chronic low back pain, zygapophyseal joint syndrome, Facet syndrome
Brief summary
Double arm pivotal study to evaluate the Neurolyser XR as a non-invasive treatment of axial chronic low back pain
Detailed description
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 zygapophyseal joint syndrome. Safety is measured by the incidence and severity of treatment related adverse events. Efficacy is measured by pain numerical rating scale
Interventions
DEVICENon-Invasive Thermal Ablation of the Medial Branch Nerves (Neurolyser XR)
Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound
OTHERSham procedure
Sham procedure done in an identical manner to the treatment arm, but without deploying acoustical energy
Sponsors
FUSMobile Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The sham procedure would be done using the same system and setup. Randomization would be done using an EDC system and no person at the room would know if the procedure is a treat or sham procedure.
Intervention model description
Double arm randomized study
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS | Base line, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure | Change in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain |
| Procedure and Device Safety up to six months post procedure | 6 months after procedure | Safety will be measured by the incidence and severity of treatment related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) | Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure | Low Back Pain Questionnaire (Range: 0% to 100%) |
| Patient Global Impression of Change (PGIC) | Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure | Patient Global Impression of Change (Range: 1 to 7) |
Countries
United States
Outcome results
None listed