Clinical trial NCT05154448: Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain
Official title: High-Intensity Focused Ultrasound Ablation With the Neurolyser XR Device for the Treatment of Chronic Low Back Pain: a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facet Syndrome of Lumbar Spine
Keywords: chronic low back pain
zygapophyseal joint syndrome
Facet syndrome
Lead sponsor: FUSMobile Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-13
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double arm randomized study
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: NRS
timeFrame: Base line, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure
measure: Procedure and Device Safety up to six months post procedure
timeFrame: 6 months after procedure
Secondary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure
measure: Patient Global Impression of Change (PGIC)
timeFrame: Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure
Other outcomes:
Locations:
city: Stamford
country: United States
facility: Stamford Hospital
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo University Jacksonville
state: Florida
city: Miami
country: United States
facility: Univ of Miami Rehabilitation Medicine
state: Florida
city: Atlanta
country: United States
facility: Emory
state: Georgia
city: Atlanta
country: United States
facility: The Physicians Spine and Rehabilitation Specialist of GA
state: Georgia
city: Augusta
country: United States
facility: Charlie Norwood VA Medical Center
state: Georgia
city: New York
country: United States
facility: Ainsworth Institute of Pain Management
state: New York
city: Winston-Salem
country: United States
facility: Center for Clinical Research
state: North Carolina
city: Charlottesville
country: United States
facility: University of Virginia Pain Management Center
state: Virginia
city: Virginia Beach
country: United States
facility: Gershon Pain Specialists
state: Virginia
Study officials:
References: