Neurolyser XR for the Treatment of Sacroiliitis

Sponsor
Federico II University
Study ID
NCT07647757
Status
Not Yet Recruiting

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Conditions

  • Low Back Pain
  • Sacroiliitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jun 15, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HIFU patients

Primary Outcome Measure

Pain intensity [ Time Frame: From the enrollment to the end of 6 month follow-up ]

Central Contacts

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