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Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT04129034
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : August 18, 2021
Sponsor:
Information provided by (Responsible Party):
FUSMobile Inc.

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Facet Syndrome of Lumbar Spine Device: Neurolyser XR Not Applicable

Detailed Description:

Study design: Prospective, single arm

Timeline: six month enrollment period and 12 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, non-randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain
Actual Study Start Date : September 24, 2019
Estimated Primary Completion Date : September 24, 2022
Estimated Study Completion Date : September 24, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound
 Device: Neurolyser XR
Non-Invasive Thermal Ablation of the Medial Branch Nerves


Outcome Measures
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Primary Outcome Measures :
  1. NRS [ Time Frame: Time Frame: Base line, 2 days 1, 2 & 4 weeks, 3, 6 & 12 months after procedure ]
    Change in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain

  2. Procedure and Device Safety at six months as measured by measured by the incidence and severity of treatment related adverse events [ Time Frame: Time Frame: 6 months after procedure ]
    Safety will be measured by the incidence and severity of treatment related adverse events


Secondary Outcome Measures :
  1. Lesion Size [ Time Frame: 2 days post procedure ]
    Lesion size and location as shown in MRI Image, 2 days post treatment.

  2. Oswestry Disability Index (ODI) [ Time Frame: Time Frame: Base line, 1, & 4 weeks, 3, 6 & 12 months after procedure ]
    Low Back Pain Questionnaire (Range: 0% to 100%)

  3. Short Form 12 (SF-12) [ Time Frame: Time Frame: Base line, 1, & 4 weeks, 3, 6 & 12 months after procedure ]
    A multipurpose short form survey with 12 questions (Range: 0 to 100)

  4. Patient Global Impression of Change (PGIC) [ Time Frame: Time Frame: Base line, 1, & 4 weeks, 3, 6 & 12 months after procedure ]
    Patient Global Impression of Change (Range: 1 to 7)

  5. Procedure and Device Safety as measured by measured by the incidence and severity of treatment related adverse events [ Time Frame: Time Frame: Base line, Procedure day, 2 days 1, 2 & 4 weeks, 3, 6 & 12 months after procedure ]
    Safety will be measured by the incidence and severity of treatment related adverse events


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129034


Contacts
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Contact: Michael Gofeld, MD 416.512.6407 mikegofeld@gmail.com

Locations
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Canada, British Columbia
Kinetix Medicine Not yet recruiting
Vancouver, British Columbia, Canada, BC V6K 2E4
Contact: Jillian Fyvie    604.416.0630    jillian@kinetixmedicine.com   
Canada, Ontario
Precision Sport & Spine Recruiting
Oakville, Ontario, Canada, L6L 1H5
Contact: Magen Clark    905-857-5755    admin@precisionss.ca   
Silver Medical Group Recruiting
Toronto, Ontario, Canada, M3H 5S4
Contact: Annelise Marsig    416.512.6407    annelise.marsig@silverpaincare.com   
Toronto Western Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Jamal Kara    (416)-603-5800 ext 6237    jamal.kara@uhn.ca   
Contact: Deepti Kallam    (416)-603-5800 ext 2016    deepti.kallam@uhnresearch.ca   
Canada, Quebec
Alan Edwards Pain Management Unit - Montreal General Hospital Not yet recruiting
Montréal, Quebec, Canada, H3G 1A4
Contact: Sylvie Toupin       sylvie.toupin@muhc.mcgill.ca   
Sponsors and Collaborators
FUSMobile Inc.
More Information
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Responsible Party: FUSMobile Inc.
ClinicalTrials.gov Identifier: NCT04129034    
Other Study ID Numbers: LBP-002
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by FUSMobile Inc.:
chronic low back pain
zygapophyseal joint syndrome
Facet syndrome
Additional relevant MeSH terms:
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Syndrome
Back Pain
Low Back Pain
Disease
 Pathologic Processes
Pain
Neurologic Manifestations