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

NCT06053255 | Recruiting FDA Device

• 1 other identifier: SIJ-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sacroiliitis

Keywords

neurolysis; high-intensity focused ultrasound; nerve ablation; neurotomy; sacral joint pain

Outcome Measures

Primary Outcomes (1)

• The number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0.

  Per the CTCAE assessment, each organ or possible adverse event would be categorized on a scale of 1 to 5 where: Grade 1 is Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 is Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 is Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 is Life-threatening consequences; urgent intervention indicated. Grade 5 is Death related to AE.

  Procedure through 6 month follow-up visit

Secondary Outcomes (3)

• The participants change in level of pain as assessed by the Numerical Rating Scale (NRS) and any change in analgesic/opiate usage.

  Procedure through 6 month follow-up visit

• Change in quality of life will be assessed by Oswestry Disability Index (ODI)

  Procedure through 6 month follow-up visit

• Change in quality of life will be assessed also by Brief Pain Inventory (BPI-QOL)

  Procedure through 6 month follow-up visit

Study Arms (1)

HIFU for Sacroiliitis

EXPERIMENTAL

High-intensity focused ultrasound delivered to the lateral sacral branch nerve for neurolysis.

Device: High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XR

Interventions

High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XR DEVICE

HIFU is delivered via a non-invasive ultrasonic transducer, through a gel pad for acoustic coupling, into the patients body in a precise manner focused on the lateral sacral branch nerves.

HIFU for Sacroiliitis

Eligibility Criteria

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

You may qualify if:

• Men and women aged 18 and older
• BPI \< 40
• Patients who are able and willing to give consent and able to attend all study visits.
• Patients who are able to communicate with the treating physician.
• Patients must have chronic lower back pain (LBP) attributed to degenerative sacroiliitis diagnosed by a pain physician using the following guidelines:
• At least 1 positive sacroiliac joint provocation test (Gaeslen's test, FABER (Patrick's test), and pelvic rock)
• Back pain predominantly below L5
• % 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).
• 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)
• Patients with NRS (0-10 scale) LBP average score ≥ 4
• Patients with chronic LBP for at least 12 months.
• Patients with Oswestry Disability Questionnaire (ODQ) for LBP score \> 40%

You may not qualify if:

• Patients on dialysis
• 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).
• Spinal pathology that may impede recovery such as spina bifida occulta, grade II or higher.
• Spondylolisthesis at L5/S1, or scoliosis
• Patients with radiofrequency ablation (RF/RFA) treatment for sacroiliitis LBP
• Patients with bilateral sacroiliitis LBP
• Patients with previous low back surgery
• Patients who are pregnant
• Patients with existing malignancy
• Patients with allergies to relevant anesthetics
• Patients with motor deficit or any other indication for surgical intervention
• Patients with contraindications for MRI
• 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.
• Patients with unstable cardiac status including:
• Unstable angina pectoris on medication

Sponsors & Collaborators

• FUSMobile Inc.: lead
• Focused Ultrasound Foundation: collaborator

Study Sites (1)

University of Virginia, Department of Anesthesiology

Charlottesville, Virginia, 22903, United States

RECRUITING

Related Publications (1)

• Perez J, Gofeld M, Leblang S, Hananel A, Aginsky R, Chen J, Aubry JF, Shir Y. Fluoroscopy-Guided High-Intensity Focused Ultrasound Neurotomy of the Lumbar Zygapophyseal Joints: A Clinical Pilot Study. Pain Med. 2022 Jan 3;23(1):67-75. doi: 10.1093/pm/pnab275.

  PMID: 34534337 BACKGROUND

MeSH Terms

Conditions

Sacroiliitis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Lynn Kohan, MD

  University of Virginia Pain Medicine Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexi Moruza

CONTACT

434-243-5676; AM2JT@uvahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 10 participant feasibility study

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 25, 2023
• Study Start: September 13, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)