Neurolyser XR for the Treatment of Sacroiliitis

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neuroscience, Reproductive and Odontostomatological Sciences

Naples, 80131, Italy

Location contact

Pasquale Buonanno, Professor

CONTACT

[email protected]

+390817463705

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

Pain intensity

Time frame: From the enrollment to the end of 6 month follow-up

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

Study contacts

Contact information is provided by the study sponsor or research team.

Pasquale Buonanno, Professor

CONTACT

[email protected]

+39 081 7463705

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jun 15, 2026
Registry last updated: Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed