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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

10 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

FUSMobile Inc.

Study start

Sep 13, 2024 Actual

Primary completion

May 26, 2027 Estimated

Study completion

Jul 15, 2027 Estimated

First posted

Sep 25, 2023 Actual

Last updated

Nov 9, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.