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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
University of Virginia, Department of Anesthesiology
Charlottesville, Virginia, United States
RECRUITINGThe 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.
Time frame: Procedure through 6 month follow-up visit
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
Time frame: Procedure through 6 month follow-up visit
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
Time frame: Procedure through 6 month follow-up visit
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.
Time frame: Procedure through 6 month follow-up visit
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