Evaluating NeurolyserXR for treating sacroiliac joint pain

Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Sacroiliac Joint Related Low Back Pain

This study is testing a new device called Neurolyser XR to see if it can safely reduce pain and improve function in adults with sacroiliac joint pain.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: FUSMobile Inc. (Industry-sponsored)
• Locations: 1 site (Givatayim)
• Trial ID: NCT05396495 on ClinicalTrials.gov

What this trial studies

This pilot study aims to assess the safety and effectiveness of the Neurolyser XR device, which utilizes high-intensity focused ultrasound for non-invasive thermal ablation of the posterior sacral nerve branches. The study will involve adult participants suffering from sacroiliitis, who will be treated and followed for up to six months. Primary endpoints include monitoring treatment-related adverse events for safety and measuring changes in pain scores and disability levels for effectiveness. The study is designed as an open-label, single-arm intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with a history of sacroiliac joint pain lasting more than six months and a positive response to previous nerve ablation or block procedures.

Not a fit: Patients with neurological deficits, recent spinal surgery, or those outside the age range of 18 to 80 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-invasive option for patients suffering from sacroiliac joint pain, potentially improving their quality of life.

How similar studies have performed: While this approach is innovative, similar studies using focused ultrasound for pain management have shown promising results, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Adult male and females, legally able and willing to participate in the study and come for follow-up visits
2. Able and willing to fill the research questionnaires and to communicate with investigator and research team
3. Patient with bilateral or unilateral sacroiliac joint pain of \> 6 months duration
4. Patients presenting with a) a positive (\>70% pain relief) to a previous nerve ablation procedure of the sacroiliac joint and / or b) with a positive (\>70% pain relief) to a previous nerve block procedure of the sacroiliac joint within the last six months)
5. Average pain score of 4 or higher in the last month, (on 0-10 scale).

Exclusion Criteria:

1. Pregnant or breastfeeding patient
2. Patients younger than 18 or older than 80 years
3. Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).
4. Patients with history of lumbar and / or sacral spine surgery
5. Patients with the presence of metal hardware at the lumbosacral spine
6. Patients with history of pelvic pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event (per the discretion of the study PI)
7. Patients unable to understand and complete the research questionnaires in Hebrew.
8. Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome.
9. Patient with extensive scarring in the skin and tissue overlying the treatment area.
10. Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project

Where this trial is running

Givatayim

• Sheba Medical Center — Givatayim, Israel (Recruiting)

Study contacts

• Study coordinator: Glia Pesah

Conditions Sacroiliitis