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

Completed · Not applicable · Has a placebo group

Conditions studied: Facet Syndrome of Lumbar Spine

In brief

Double arm pivotal study to evaluate the Neurolyser XR as a non-invasive treatment of axial chronic low back pain

Key facts

Study ID

NCT05154448

Run by

FUSMobile Inc.

People needed

90

Starts

2022-05-16

Expected to finish

2024-04-16

Last updated by the study team

2025-02-07

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 50 to 85 years old, legally able and willing to participate in the study and all follow-up visits
• Able and willing to complete the research questionnaires and to communicate with investigator and research team
• Individual with current bilateral or unilateral low back pain of > 6 months duration
• Individual whose back pain is alleviated by recumbency or comfortable sitting position
• 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
• Average low back pain score of 6 or higher in the last month (on 0-10 scale) with activity

You may not qualify if…

• Individuals who are pregnant or breastfeeding
• Individuals younger than 50 or older than 85 years
• 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.
• Individuals presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain)
• Individuals with history of lumbar or lumbosacral spine surgery
• Individuals who have had lumbar radiofrequency neurotomy in the past 6 months
• 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)
• Individuals presenting with any severe medical condition preventing them from participation (per investigator's discretion) (Example: inability to lay prone)
• Individuals with extensive scarring of the skin and tissue overlying the treatment area
• Individuals enrolled in or planned to be enrolled in another clinical trial during the duration of this research project
• Any Individuals with an uncontrolled coagulopathy
• Individuals with known osteoporosis with absolute risk of spinal fracture of > 10% over 10 years
• 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
• Individuals with rheumatologic diseases causing spine pain that are currently receiving active treatment including steroids, disease modifying drugs, biological agents or immunosuppressants
• Individuals known for concomitant psychiatric disorders, excluding compensated mood disorders
• Individuals with first-degree family member already enrolled in this study
• 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)
• Individuals diagnosed with co-morbid multifocal chronic pain (e.g. fibromyalgia, generalized osteoarthritis)
• Individuals with other chronic pain that is 2 or more points higher on the NRS score than the participants low back pain
• Individuals who have had a steroid injection within the last 2 months from date of enrollment at the location of the planned treatment
• Any individuals with clinical or radiographic evidence of dynamic instability of the lumbar spine

Where it is running

• Stamford Hospital — Stamford, Connecticut, United States
• Mayo University Jacksonville — Jacksonville, Florida, United States
• Univ of Miami Rehabilitation Medicine — Miami, Florida, United States
• Emory — Atlanta, Georgia, United States
• The Physicians Spine and Rehabilitation Specialist of GA — Atlanta, Georgia, United States
• Charlie Norwood VA Medical Center — Augusta, Georgia, United States
• Ainsworth Institute of Pain Management — New York, New York, United States
• Center for Clinical Research — Winston-Salem, North Carolina, United States
• University of Virginia Pain Management Center — Charlottesville, Virginia, United States
• Gershon Pain Specialists — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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