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Recruiting Not applicable

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

NCT06053255 · tracked via the Priya Life Science USA tracker
Sponsor
FUSMobile Inc
Phase
Not applicable
Started
2024-09-13
Last updated
2025-05-22

Condition(s) studied

Sacroiliitis

Investigational drug(s) / intervention(s)

High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XR

High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XR: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Men and women aged 18 and older 2. BPI \< 40 3. Patients who are able and willing to give consent and able to attend all study visits. 4. Patients who are able to communicate with the treating physician. 5. Patients must have chronic lower back pain (LBP) attributed to degenerative sacroiliitis diagnosed by a pain physician using the following guidelines: 6. At least 1 positive sacroiliac joint provocation test (Gaeslen's test, FABER (Patrick's test), and pelvic rock) 7. Back pain predominantly below L5 8. 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). 9. 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) 10. Patients with NRS (0-10 scale) LBP average score ≥ 4 11. Patients with chronic LBP for at least 12 months. 12. Patients with Oswestry Disability Questionnaire (ODQ) for LBP score \> 40% Exclusion Criteria: 1. Patients on dialysis 2. 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). 3. Spinal pathology that may impede recovery such as spina bifida occulta, grade II or higher. 4. Spondylolisthesis at L5/S1, or scoliosis 5. Patients with radiofrequency ablation (RF/RFA) treatment for sacroiliitis LBP 6. Patients with bilateral sacroiliitis LBP 7. Patients with previous low back surgery 8. Patients who are pregnant 9. Patients with existing malignancy 10. Patients with allergies to relevant anesthetics 11. Patients with motor deficit or any other indication for surgical intervention 12. Patients with contraindications for MRI 13. 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. 14. Patients with unstable cardiac status including: 15. Unstable angina pectoris on medication 16. Patients with documented myocardial infarction less than 40 days prior to protocol enrolment 17. Patients with Severe Congestive Heart Failure, New York Heart Association (NYHA) class 4. 18. Patients on anti-arrhythmic drugs or with uncontrolled and/or untreated arrhythmia status 19. Patients with severe cerebrovascular disease (CVA within last 6 months) 20. Patients with severe hypertension (diastolic BP \> 100 on medication) 21. Patient Body Mass Index \> 45 or \<20 22. Patients with known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease 23. Patients with an active infection or severe hematological, neurological, or other uncontrolled disease. 24. The patient is unable to communicate with the investigator and staff. 25. Patients who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hours) 26. Patient with acute pelvic inflammatory conditions 27. Ongoing/ unresolved Worker's compensation, injury litigation, military medical board, or disability remuneration claims 28. Morphine Milligram Equivalents (MME) \> 60 per 24 hrs. 29. Patients with platelets \< 100.

Primary outcome measure(s)

  • The number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0. — Procedure through 6 month follow-up visit
    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.

Trial sites (1)

FacilityCityRegionStatus
University of Virginia, Department of Anesthesiology Charlottesville Virginia Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06053255 on ClinicalTrials.gov ↗ ← All trials in the USA