Fluoroscopy-Guided High-Intensity Focused Ultrasound Neurotomy of the Lumbar Zygapophyseal Joints: A Clinical Pilot Study.
Jordi Perez, Michael Gofeld, Suzanne Leblang...
https://pubmed.ncbi.nlm.nih.gov/34534337Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06053255
Safety and Efficacy of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis
Led by FUSMobile Inc. · Updated on 2025-05-22
10
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
F
FUSMobile Inc.
Lead Sponsor
F
Focused Ultrasound Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the use of the Neurolyser XR device, which delivers high-intensity focused ultrasound (HIFU), for treating low back pain caused by sacroiliitis. Sacroiliitis involves inflammation and arthritis in the sacroiliac joint, which connects the sacrum to the iliac bone in the lower spine and bears the body's weight. The study focuses on the safety and effects of using sound waves to target and damage nerves that carry pain signals from this joint. The treatment involves using the Neurolyser XR device to deliver focused ultrasound energy non-invasively to the lateral sacral branch nerves near the sacroiliac joint. This energy raises the temperature at the nerve site to intentionally damage the pain-transmitting fibers. Participants will receive this nerve ablation to study its impact on their pain. Participants will be monitored through various assessments including the number of treatment-related adverse events using standard criteria, pain levels measured by the Numerical Rating Scale, changes in pain medication use, and quality of life evaluated by the Oswestry Disability Index and Brief Pain Inventory. These evaluations will occur through a 6-month follow-up period. The study involves multiple visits for treatment and monitoring over this time to gather safety and effectiveness data.
CONDITIONS
Brief Title
Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 and older
- BPI (Brief Pain Inventory) score less than 40
- Able and willing to give consent and attend all study visits
- Able to communicate with the treating physician
- Chronic lower back pain attributed to degenerative sacroiliitis diagnosed by a pain physician
- At least one positive sacroiliac joint provocation test (Gaeslen's test, FABER, or pelvic rock)
- Back pain predominantly below the L5 vertebra
- At least 50% pain relief following sacroiliac joint injection or lateral branch blocks
- Other sources of low back pain ruled out by exam and imaging
- Average low back pain score of 4 or higher on the Numerical Rating Scale
- Chronic low back pain for at least 12 months
- Oswestry Disability Questionnaire score greater than 40%
You will not qualify if you...
- Patients on dialysis
- Evidence of lumbosacral radiculopathy or radicular leg pain
- Spinal pathology impeding recovery such as spina bifida occulta or grade II or higher
- Spondylolisthesis at L5/S1 or scoliosis
- Previous radiofrequency ablation treatment for sacroiliitis
- Bilateral sacroiliitis low back pain
- Previous low back surgery
- Pregnancy
- Existing malignancy
- Allergies to relevant anesthetics
- Motor deficit or indication for surgical intervention
- Contraindications for MRI
- Acute medical conditions hindering study completion
- Unstable cardiac status or recent myocardial infarction
- Severe congestive heart failure (NYHA class 4)
- Use of anti-arrhythmic drugs or uncontrolled arrhythmia
- Severe cerebrovascular disease within last 6 months
- Severe hypertension with diastolic BP over 100 on medication
- Body Mass Index over 45 or under 20
- Intolerance or allergy to MRI contrast agents
- Active infection or severe uncontrolled disease
- Unable to communicate with study staff
- Unable or unwilling to tolerate prolonged stationary position during treatment
- Acute pelvic inflammatory conditions
- Ongoing or unresolved legal or military compensation claims
- Morphine equivalent dose over 60 mg per 24 hours
- Platelet count below 100
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Single treatment session
Participants receive a non-invasive high-intensity focused ultrasound treatment targeted at the lateral sacral branch nerves to reduce low back pain related to sacroiliitis.
1 visit (in-person)
Follow-up
Duration - Up to 6 months
Participants are monitored for treatment safety and efficacy, including assessments of pain levels and quality of life.
Multiple visits during 6 month follow-up period
Trial Site Locations
Total: 1 location
1
University of Virginia, Department of Anesthesiology
Charlottesville, Virginia, United States, 22903
Actively Recruiting
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Research Team
A
Alexi Moruza
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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