Using Neurolyser XR to treat low back pain from sacroiliitis

Safety and Efficacy of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis

This study is testing if the Neurolyser XR device can help people with low back pain from sacroiliitis by using ultrasound to target and reduce pain signals from a specific nerve.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: FUSMobile Inc. (Industry-sponsored)
• Locations: 1 site (Charlottesville, Virginia)
• Trial ID: NCT06053255 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the Neurolyser XR device, which utilizes high-intensity focused ultrasound (HIFU) to ablate the lateral sacral branch nerve in patients suffering from sacroiliitis. The procedure aims to alleviate chronic lower back pain by intentionally damaging the nerve fibers that transmit pain signals. Participants will undergo assessments to confirm their eligibility based on specific criteria related to their pain condition and previous treatments. The study is conducted at the University of Virginia's Department of Anesthesiology.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic lower back pain attributed to degenerative sacroiliitis.

Not a fit: Patients with low back pain from sources other than sacroiliitis may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce chronic low back pain for patients with sacroiliitis.

How similar studies have performed: Other studies using high-intensity focused ultrasound for pain management have shown promising results, indicating potential success for this approach.

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.

Where this trial is running

Charlottesville, Virginia

• University of Virginia, Department of Anesthesiology — Charlottesville, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Lynn Kohan, MD — University of Virginia Pain Medicine Clinic
• Study coordinator: Alexi Moruza

Conditions Sacroiliitis; neurolysis; high-intensity focused ultrasound; nerve ablation; neurotomy; sacral joint pain