NCT06053255 Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis
| NCT ID | NCT06053255 |
| Status | Recruiting |
| Phase | — |
| Sponsor | FUSMobile Inc. |
| Condition | Sacroiliitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-09-13 |
| Primary Completion | 2026-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-09-13 with a primary completion date of 2026-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Lynn Kohan, MD
PRINCIPAL INVESTIGATOR
University of Virginia Pain Medicine Clinic
Frequently Asked Questions
Who can join the NCT06053255 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sacroiliitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06053255 currently recruiting?
Yes, NCT06053255 is actively recruiting participants. Contact the research team at AM2JT@uvahealth.org for enrollment information.
Where is the NCT06053255 trial being conducted?
This trial is being conducted at Charlottesville, United States.
Who is sponsoring the NCT06053255 clinical trial?
NCT06053255 is sponsored by FUSMobile Inc.. The principal investigator is Lynn Kohan, MD at University of Virginia Pain Medicine Clinic. The trial plans to enroll 10 participants.