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

CompletedNot applicableNCT05154448
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

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
Conditions
  • Facet Syndrome of Lumbar Spine
Interventions
  • Device: Non-Invasive Thermal Ablation of the Medial Branch Nerves (Neurolyser XR)
  • Other: Sham procedure
Sponsor
FUSMobile Inc.
Start date
2022-05-16
Primary completion
2024-04-16
Sex
All
Age range
from 50 Years to 85 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
10

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 …

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05154448