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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04129034
Other study ID # LBP-002
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 24, 2019
Est. completion date March 26, 2023

Study information

Verified date November 2022
Source FUSMobile Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a high intensity focused ultrasound device, for non-invasive treatment of axial chronic low back pain


Description:

Study design: Prospective, single arm Timeline: six month enrollment period and 6 months follow-up period. Sites: The study will be conducted at five sites in Canada: McGill University, Toronto Western, Silver Medical Group, Precision Sport & Spine, Kinetix Integrated Orthopaedic & Regenerative Medicine Study population: Thirty adult patients diagnosed with facet related low back pain. 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 the changes in pain severity at the treatment area, using a numerical rating scale (NRS), of 0 to 10 between baseline and 6 months.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date March 26, 2023
Est. primary completion date October 26, 2022
Accepts healthy volunteers No
Gender All
Age group 55 Years to 85 Years
Eligibility Inclusion Criteria: 1. Adult male and females >55 years of age legally able and willing to participate in the study and come for follow-up visits 2. Able and willing to fill the research questionnaires and to communicate with investigator and research team 3. Patient with bilateral or unilateral low back pain of > 6 months duration 4. Patients whose back pain is alleviated by recumbency or comfortable sitting position 5. Patients presenting with a) a positive (>70% pain relief) to a previous, single or double, L1 to L5 lumbar medial branch block (within the last 12 months) and / or b) with a positive (>70% pain relief lasting more than 6 months) to a previous lumbar facet thermal radiofrequency denervation. 6. Average pain score of 6 or higher in the last month, (on 0-10 scale). Exclusion Criteria: 1. Pregnant or breastfeeding patient 2. Patients younger than 55 or older than 85 years 3. Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain). 4. Patients with history of lumbosacral spine surgery excluding previous lumbar radiofrequency neurotomy 5. Patients who have had lumbar radiofrequency neurotomy in the past 6 months 6. Patients with the presence of metal hardware or other foreign objects at the lumbosacral spine 7. Patients with history of lumbar spine pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event, (per the discretion of the study PI) 8. Patients unable to understand and complete the research questionnaires in the official language used within the particular sites' location. 9. Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome per PI decision. 10. Patient with extensive scarring of the skin and tissue overlying the treatment area. 11. Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project 12. Any patients with an uncontrolled coagulopathy 13. Patients with known osteoporosis with absolute risk of spinal fracture of >10% over 10 years will be excluded 14. Any patients with a history of malignant disease in the past five years 15. Patients with rheumatologic diseases causing spine pain that are currently receiving active treatment including steroids, disease modifying drugs, biological agents or immunosuppressants. 16. Patients known for concomitant psychiatric disorders, excluding mood disorders. 17. Patients presenting with concomitant mood disorders (deemed severe by the research physician). 18. Patients with a first-degree family member already enrolled in this study. 19. Patient who is scheduled for any interventional/surgical procedure within 3 months from screening date 20. Patients diagnosed with co-morbid multifocal chronic pain (e.g., fibromyalgia)

Study Design


Intervention

Device:
Neurolyser XR
Non-Invasive Thermal Ablation of the Medial Branch Nerves

Locations

Country Name City State
Canada Alan Edwards Pain Management Unit - Montreal General Hospital Montréal Quebec
Canada Precision Sport & Spine Oakville Ontario
Canada Silver Medical Group Toronto Ontario
Canada Toronto Western Toronto Ontario
Canada Kinetix Medicine Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
FUSMobile Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary NRS Change in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain Time Frame: Base line, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure
Primary Procedure and Device Safety at six months as measured by measured by the incidence and severity of treatment related adverse events Safety will be measured by the incidence and severity of treatment related adverse events Time Frame: 6 months after procedure
Secondary Lesion Size Lesion size and location as shown in MRI Image, 2 days post treatment. 2 days post procedure
Secondary Oswestry Disability Index (ODI) Low Back Pain Questionnaire (Range: 0% to 100%) Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure
Secondary Short Form 12 (SF-12) A multipurpose short form survey with 12 questions (Range: 0 to 100) Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure
Secondary Patient Global Impression of Change (PGIC) Patient Global Impression of Change (Range: 1 to 7) Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure
Secondary Procedure and Device Safety as measured by measured by the incidence and severity of treatment related adverse events Safety will be measured by the incidence and severity of treatment related adverse events Time Frame: Base line, Procedure day, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure
See also
  Status Clinical Trial Phase
Completed NCT03770585 - Fluoroscopy Guided Lumbar Facet Joint Injection Versus Ultrasound Guided Injection in Patients With Low Back Pain Due to Facet Syndrome N/A
Active, not recruiting NCT05154448 - Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain N/A
Recruiting NCT04893720 - The SPINUS II Study: Spinal Fusion for Multilevel SPECT/CT Positive Lumbar Degeneration
Recruiting NCT06325631 - Comparative Evaluation of the Results of Facet Joint Injections N/A
Recruiting NCT03564418 - Ultrasound-Guided Thermocoagulation of Medial Nerve Branch in Lumbar Facet Joints Pain. N/A
Completed NCT04519541 - RAMBAM 021: Safety and Initial Feasibility of the Neurolyser XR for the Treatment of Chronic Low Back Pain N/A
Recruiting NCT03871192 - Injections in the Diagnosis and Treatment of Lumbar Facet Syndrome N/A