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Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis

Primary Purpose

Sacroiliitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XR
Sponsored by
FUSMobile Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sacroiliitis focused on measuring neurolysis, high-intensity focused ultrasound, nerve ablation, neurotomy, sacral joint pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Men and women aged 18 and older BPI < 40 Patients who are able and willing to give consent and able to attend all study visits. Patients who are able to communicate with the treating physician. Patients must have chronic lower back pain (LBP) attributed to degenerative sacroiliitis diagnosed by a pain physician using the following guidelines: At least 1 positive sacroiliac joint provocation test (Gaeslen's test, FABER (Patrick's test), and pelvic rock) Back pain predominantly below L5 50% relief following either sacroiliac joint (SI) joint injection and/or lateral branch blocks corresponding to the expected duration of the medication utilized. (i.e SI joint injection-expected pain relief duration of steroid, lateral branch blocks-expected pain relief duration of local anesthetic utilized). All other possible sources of low back pain have been ruled out as the primary pain generator, including but not limited to: the intervertebral discs, bone fracture, the zygapophyseal joints, the hip joint, symptomatic spondylolisthesis, tumor, and other regional soft tissue structures (this is done by physical exam, medical history, and MRI/CT/X-ray as required) Patients with NRS (0-10 scale) LBP average score ≥ 4 Patients with chronic LBP for at least 12 months. Patients with Oswestry Disability Questionnaire (ODQ) for LBP score > 40% Exclusion Criteria: Patients on dialysis Patients with evidence of lumbosacral radiculopathy on MRI, CT or physical exam findings, including radicular leg pain (symptomatic moderate or severe foraminal or central canal stenosis). Spinal pathology that may impede recovery such as spina bifida occulta, grade II or higher. Spondylolisthesis at L5/S1, or scoliosis Patients with radiofrequency ablation (RF/RFA) treatment for sacroiliitis LBP Patients with bilateral sacroiliitis LBP Patients with previous low back surgery Patients who are pregnant Patients with existing malignancy Patients with allergies to relevant anesthetics Patients with motor deficit or any other indication for surgical intervention Patients with contraindications for MRI Patients with an acute medical condition (e.g., pneumonia, sepsis, systemic infection, uncontrolled immunosuppression-AIDS, cancer, DM) that is expected to hinder them from completing this study. Patients with unstable cardiac status including: Unstable angina pectoris on medication Patients with documented myocardial infarction less than 40 days prior to protocol enrolment Patients with Severe Congestive Heart Failure, New York Heart Association (NYHA) class 4. Patients on anti-arrhythmic drugs or with uncontrolled and/or untreated arrhythmia status Patients with severe cerebrovascular disease (CVA within last 6 months) Patients with severe hypertension (diastolic BP > 100 on medication) Patient Body Mass Index > 45 or <20 Patients with known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease Patients with an active infection or severe hematological, neurological, or other uncontrolled disease. The patient is unable to communicate with the investigator and staff. Patients who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hours) Patient with acute pelvic inflammatory conditions Ongoing/ unresolved Worker's compensation, injury litigation, military medical board, or disability remuneration claims Morphine Milligram Equivalents (MME) > 60 per 24 hrs. Patients with platelets < 100.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    HIFU for Sacroiliitis

    Arm Description

    High-intensity focused ultrasound delivered to the lateral sacral branch nerve for neurolysis.

    Outcomes

    Primary Outcome Measures

    The number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
    Per the CTCAE assessment, each organ or possible adverse event would be categorized on a scale of 1 to 5 where: Grade 1 is Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 is Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 is Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 is Life-threatening consequences; urgent intervention indicated. Grade 5 is Death related to AE.

    Secondary Outcome Measures

    The participants change in level of pain as assessed by the Numerical Rating Scale (NRS) and any change in analgesic/opiate usage.
    The pain scale is 0 to 10 where 0 is no pain at all and 10 is the worst pain imaginable
    Change in quality of life will be assessed by Oswestry Disability Index (ODI)
    ODI scale includes 10 questions, each can score 0 to 5 for a total score of 0 to 50. scores are interpreted as follows: 0-4: No disability 5-14: Mild disability 15-24: Moderate disability 25-34: Severe disability 35-50: Completely disabled
    Change in quality of life will be assessed also by Brief Pain Inventory (BPI-QOL)
    BPI includes 7 questions on the level the patient pain interferes with their daily activities. Each question can score 0 to 10 for a total score of 0 to 70.

    Full Information

    First Posted
    September 6, 2023
    Last Updated
    October 3, 2023
    Sponsor
    FUSMobile Inc.
    Collaborators
    Focused Ultrasound Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06053255
    Brief Title
    Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis
    Official Title
    Safety and Efficacy of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 15, 2023 (Anticipated)
    Primary Completion Date
    September 15, 2024 (Anticipated)
    Study Completion Date
    December 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    FUSMobile Inc.
    Collaborators
    Focused Ultrasound Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The Neurolyser XR is a device used to deliver high-intensity focused ultrasound for the ablation of the lateral sacral branch nerve in patients with Sacroiliitis.
    Detailed Description
    The sacroiliac joint connects the sacrum (a triangle shaped bone) with the iliac bone on both sides of the lower spine. These joints transmit all the forces from the upper body to the pelvis and their respective legs. Repeated trauma and aging affect this joint resulting in inflammation and arthritic changes. These changes result in misalignment of the joint or limitation to normal motion which can create pain typically very low in the back or in the buttocks, High-Intensity Focused Ultrasound (HIFU) technology uses sound waves. These sound waves are concentrated into a specific spot in order to raise the local tissue temperature causing a burn, this burn is expected to intentionally damage the nerve causing pain. The HIFU device used in this study is called, the Neurolyser XR. It focuses sound wave energy directly on the nerve of the painful sacroiliac joint, causing an increase in temperature, which is expected to directly damage the nerve fibers which carry pain signals to the brain.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sacroiliitis
    Keywords
    neurolysis, high-intensity focused ultrasound, nerve ablation, neurotomy, sacral joint pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    10 participant feasibility study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HIFU for Sacroiliitis
    Arm Type
    Experimental
    Arm Description
    High-intensity focused ultrasound delivered to the lateral sacral branch nerve for neurolysis.
    Intervention Type
    Device
    Intervention Name(s)
    High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XR
    Intervention Description
    HIFU is delivered via a non-invasive ultrasonic transducer, through a gel pad for acoustic coupling, into the patients body in a precise manner focused on the lateral sacral branch nerves.
    Primary Outcome Measure Information:
    Title
    The number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
    Description
    Per the CTCAE assessment, each organ or possible adverse event would be categorized on a scale of 1 to 5 where: Grade 1 is Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 is Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 is Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 is Life-threatening consequences; urgent intervention indicated. Grade 5 is Death related to AE.
    Time Frame
    Procedure through 6 month follow-up visit
    Secondary Outcome Measure Information:
    Title
    The participants change in level of pain as assessed by the Numerical Rating Scale (NRS) and any change in analgesic/opiate usage.
    Description
    The pain scale is 0 to 10 where 0 is no pain at all and 10 is the worst pain imaginable
    Time Frame
    Procedure through 6 month follow-up visit
    Title
    Change in quality of life will be assessed by Oswestry Disability Index (ODI)
    Description
    ODI scale includes 10 questions, each can score 0 to 5 for a total score of 0 to 50. scores are interpreted as follows: 0-4: No disability 5-14: Mild disability 15-24: Moderate disability 25-34: Severe disability 35-50: Completely disabled
    Time Frame
    Procedure through 6 month follow-up visit
    Title
    Change in quality of life will be assessed also by Brief Pain Inventory (BPI-QOL)
    Description
    BPI includes 7 questions on the level the patient pain interferes with their daily activities. Each question can score 0 to 10 for a total score of 0 to 70.
    Time Frame
    Procedure through 6 month follow-up visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men and women aged 18 and older BPI < 40 Patients who are able and willing to give consent and able to attend all study visits. Patients who are able to communicate with the treating physician. Patients must have chronic lower back pain (LBP) attributed to degenerative sacroiliitis diagnosed by a pain physician using the following guidelines: At least 1 positive sacroiliac joint provocation test (Gaeslen's test, FABER (Patrick's test), and pelvic rock) Back pain predominantly below L5 50% relief following either sacroiliac joint (SI) joint injection and/or lateral branch blocks corresponding to the expected duration of the medication utilized. (i.e SI joint injection-expected pain relief duration of steroid, lateral branch blocks-expected pain relief duration of local anesthetic utilized). All other possible sources of low back pain have been ruled out as the primary pain generator, including but not limited to: the intervertebral discs, bone fracture, the zygapophyseal joints, the hip joint, symptomatic spondylolisthesis, tumor, and other regional soft tissue structures (this is done by physical exam, medical history, and MRI/CT/X-ray as required) Patients with NRS (0-10 scale) LBP average score ≥ 4 Patients with chronic LBP for at least 12 months. Patients with Oswestry Disability Questionnaire (ODQ) for LBP score > 40% Exclusion Criteria: Patients on dialysis Patients with evidence of lumbosacral radiculopathy on MRI, CT or physical exam findings, including radicular leg pain (symptomatic moderate or severe foraminal or central canal stenosis). Spinal pathology that may impede recovery such as spina bifida occulta, grade II or higher. Spondylolisthesis at L5/S1, or scoliosis Patients with radiofrequency ablation (RF/RFA) treatment for sacroiliitis LBP Patients with bilateral sacroiliitis LBP Patients with previous low back surgery Patients who are pregnant Patients with existing malignancy Patients with allergies to relevant anesthetics Patients with motor deficit or any other indication for surgical intervention Patients with contraindications for MRI Patients with an acute medical condition (e.g., pneumonia, sepsis, systemic infection, uncontrolled immunosuppression-AIDS, cancer, DM) that is expected to hinder them from completing this study. Patients with unstable cardiac status including: Unstable angina pectoris on medication Patients with documented myocardial infarction less than 40 days prior to protocol enrolment Patients with Severe Congestive Heart Failure, New York Heart Association (NYHA) class 4. Patients on anti-arrhythmic drugs or with uncontrolled and/or untreated arrhythmia status Patients with severe cerebrovascular disease (CVA within last 6 months) Patients with severe hypertension (diastolic BP > 100 on medication) Patient Body Mass Index > 45 or <20 Patients with known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease Patients with an active infection or severe hematological, neurological, or other uncontrolled disease. The patient is unable to communicate with the investigator and staff. Patients who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hours) Patient with acute pelvic inflammatory conditions Ongoing/ unresolved Worker's compensation, injury litigation, military medical board, or disability remuneration claims Morphine Milligram Equivalents (MME) > 60 per 24 hrs. Patients with platelets < 100.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alexi Moruza
    Phone
    434-243-5676
    Email
    AM2JT@uvahealth.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lynn Kohan, MD
    Organizational Affiliation
    University of Virginia Pain Medicine Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34534337
    Citation
    Perez J, Gofeld M, Leblang S, Hananel A, Aginsky R, Chen J, Aubry JF, Shir Y. Fluoroscopy-Guided High-Intensity Focused Ultrasound Neurotomy of the Lumbar Zygapophyseal Joints: A Clinical Pilot Study. Pain Med. 2022 Jan 3;23(1):67-75. doi: 10.1093/pm/pnab275.
    Results Reference
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    Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis

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