Actively Recruiting
Use 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
117 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
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.
CONDITIONS
Official Title
Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 and older
- Brief Pain Inventory (BPI) score less than 40
- Ability and willingness to give consent and attend all study visits
- Ability 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 mainly below L5
- At least 50% pain relief following sacroiliac joint injection or lateral branch blocks matching expected medication duration
- Other sources of low back pain ruled out by exam, history, and imaging as needed
- Numeric Rating Scale (NRS) average low back pain score of 4 or higher
- Chronic low back pain for at least 12 months
- Oswestry Disability Questionnaire score for low back pain greater than 40%
You will not qualify if you...
- Patients on dialysis
- Evidence of lumbosacral radiculopathy or leg pain from nerve root issues
- Spinal conditions such as spina bifida occulta, grade II or higher
- Spondylolisthesis at L5/S1 or scoliosis
- Previous radiofrequency ablation treatment for sacroiliitis low back pain
- Bilateral sacroiliitis low back pain
- Previous low back surgery
- Pregnancy
- Existing cancer
- Allergies to relevant anesthetics
- Motor deficits or need for surgery
- MRI contraindications
- Acute medical conditions like pneumonia, sepsis, uncontrolled immunosuppression, cancer, or diabetes
- Unstable heart conditions including unstable angina, recent heart attack, severe heart failure, arrhythmias
- Severe cerebrovascular disease within last 6 months
- Severe hypertension (diastolic > 100 on medication)
- Body Mass Index over 45 or under 20
- Allergies or intolerance to MRI contrast agents
- Active infection or severe uncontrolled disease
- Inability to communicate with study staff
- Unable or unwilling to remain still during treatment (~2 hours)
- Acute pelvic inflammatory conditions
- Ongoing workers' compensation, injury litigation, military medical board, or disability claims
- Using morphine equivalent doses over 60 mg per 24 hours
- Platelet count under 100
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia, Department of Anesthesiology
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
A
Alexi Moruza
CONTACT
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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