Neurolyser XR for the Treatment of Sacroiliitis

NCT07647757 | Not Yet Recruiting

• 1 other identifier: PB002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Our study aims to investigate the safety and efficacy of high intensity focused ultrasound in the management of low back pain due to sacroiliitis. Sacroiliitis is the inflammation of a joint in the lowest part of the spin and it is one of the cause of low back; the diagnosis is essentially based on clinical examination and the confirmation of this diagnosis relies on a significant pain relief following an infiltration of local anesthetic in the joint. One of the potential treatment is to ablate the nerves which carry the painful stimuli from the joint to the central nervous system through; these nerves enter the spinal canal through the sacral foramina which are two series of four pairs of openings located on the sacrum, the triangular bone at the base of the spine. Traditionally, these nerves are ablated by the heat produced by radiofrequency or the cold produced by cryoablation; both techniques require percutaneous needle insertion in close proximity to the targeted nerves, posing potential discomfort and risk of infection for the patient. High intensity focused ultrasound delivered by the device Neurolyser XR uses ultrasounds which are converged to the targeted point thanks to a gel pad positioned on the back of the patient; this mechanism of action does not require sterile conditions as the skin is not pierced and the discomfort of patient is dramatically reduced during the procedure for there is non need to insert and move any needle to properly position it. The correct orientation of the ultrasound beam is guaranteed by the alignment of the targeting system of the device and the X-ray image. The lesion is produced only if there is a bone right under the focus of the ultrasound beam and this is a safety system which assures that no direct injuries of other structures (e.g., vessels, spinal root) can be caused. To date, Neurolyser XR has been extensively used to treat facet joint syndrome through the ablation of the medial branches. However, its application in sacroiliitis has not yet been as deeply investigated.

Conditions

Sacroiliitis; Low Back Pain

Keywords

HIFU; High intensity focused ultrasound; sacroiliitis; low back pain; nerve ablation

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Numeric rating scale (NRS): the patient has to assign a number from 0 (no pain) to 10 (worst possible pain) to his pain

  From the enrollment to the end of 6 month follow-up

Study Arms (1)

HIFU patients

EXPERIMENTAL

Device: Patients treated with high intensity focused ultrasound

Interventions

Patients treated with high intensity focused ultrasound DEVICE

Patients in this group will be treated with high intensity focused ultrasound; they will be placed in a prone position and through radiographic guidance, the targeting system of the device will be sequentially positioned in 6-8 points along a line between sacral foramina and sacroiliac joint to produce as many lesions. Before any ablation, a 20 second stimulation at low energy will be performed to confirm the right position of the ultrasound focus than a higher intensity stimulation will be applied to perform the ablation.

HIFU patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males and females, legally able and willing to participate in the study and come for follow-up visits
• Able and willing to fill the research questionnaires and to communicate with investigator and research team
• Patient with bilateral or unilateral sacroiliac joint pain of \> 6 months duration
• 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)
• Average pain score of 4 or higher in the last month, (on 0-10 scale).

You may not qualify if:

• Pregnant or breastfeeding patient
• Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).
• Patients with history of lumbar and / or sacral spine surgery
• Patients with the presence of metal hardware at the lumbosacral spine
• 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 principal investigator)
• Patients unable to understand and complete the research questionnaires in Italian.
• Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome.
• Patient with extensive scarring in the skin and tissue overlying the treatment area.
• Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Neuroscience, Reproductive and Odontostomatological Sciences

Naples, 80131, Italy

Location

Related Publications (4)

• Gofeld M, Smith KJ, Bhatia A, Djuric V, Leblang S, Rebhun N, Aginsky R, Miller E, Skoglind B, Hananel A. Fluoroscopy-guided high-intensity focused ultrasound neurotomy of the lumbar zygapophyseal joints: a prospective, open-label study. Reg Anesth Pain Med. 2025 Jun 10;50(6):464-470. doi: 10.1136/rapm-2024-105345.

  PMID: 38580339 BACKGROUND

• Gofeld M, Tiennot T, Miller E, Rebhun N, Mobley S, Leblang S, Aginsky R, Hananel A, Aubry JF. Fluoroscopy-guided high-intensity focused ultrasound ablation of the lumbar medial branch nerves: dose escalation study and comparison with radiofrequency ablation in a porcine model. Reg Anesth Pain Med. 2025 May 6;50(5):429-436. doi: 10.1136/rapm-2024-105417.

  PMID: 38508592 BACKGROUND

• Aginsky R, LeBlang S, Hananel A, Chen J, Gofeld M, Perez J, Shir Y, Aubry JF. Tolerability and Feasibility of X-ray Guided Non-Invasive Ablation of the Medial Branch Nerve with Focused Ultrasound: Preliminary Proof of Concept in a Pre-clinical Model. Ultrasound Med Biol. 2021 Mar;47(3):640-650. doi: 10.1016/j.ultrasmedbio.2020.10.019. Epub 2020 Nov 28.

  PMID: 33261908 BACKGROUND

• Mahapatra S, Francois H, Weber-Levine C, Jiang K, Bhimreddy M, Boateng A, Davidar AD, Routkevitch D, Chhatre A, Manbachi A, Theodore N. Focused ultrasound for the treatment of facet joint pain: a systematic review. Neurosurg Focus. 2024 Sep 1;57(3):E9. doi: 10.3171/2024.6.FOCUS24249.

  PMID: 39217639 BACKGROUND

MeSH Terms

Conditions

Sacroiliitis; Low Back Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pasquale Buonanno, Professor

CONTACT

+39 081 7463705; pasquale.buonanno@unina.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

IT (1)