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

• ClinicalTrials.gov Identifier: NCT06053255
• Recruitment Status: Not yet recruiting
• First Posted: September 25, 2023
• Last Update Posted: October 5, 2023
• Sponsor: FUSMobile Inc.
• Collaborator: Focused Ultrasound Foundation
• Information provided by (Responsible Party): FUSMobile Inc.

Tracking Information

• First Submitted Date: September 6, 2023
• First Posted Date: September 25, 2023
• Last Update Posted Date: October 5, 2023
• Estimated Study Start Date: November 15, 2023
• Estimated Primary Completion Date: September 15, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 21, 2023)

The number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0. [ Time Frame: Procedure through 6 month follow-up visit ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 21, 2023)

• The participants change in level of pain as assessed by the Numerical Rating Scale (NRS) and any change in analgesic/opiate usage. [ Time Frame: Procedure through 6 month follow-up visit ]
  The pain scale is 0 to 10 where 0 is no pain at all and 10 is the worst pain imaginable
• Change in quality of life will be assessed by Oswestry Disability Index (ODI) [ Time Frame: Procedure through 6 month follow-up visit ]
  ODI scale includes 10 questions, each can score 0 to 5 for a total score of 0 to 50. scores are interpreted as follows: 0-4: No disability 5-14: Mild disability 15-24: Moderate disability 25-34: Severe disability 35-50: Completely disabled
• Change in quality of life will be assessed also by Brief Pain Inventory (BPI-QOL) [ Time Frame: Procedure through 6 month follow-up visit ]
  BPI includes 7 questions on the level the patient pain interferes with their daily activities. Each question can score 0 to 10 for a total score of 0 to 70.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis
• Official Title: Safety and Efficacy of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis
• 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.

Detailed Description

The sacroiliac joint connects the sacrum (a triangle shaped bone) with the iliac bone on both sides of the lower spine. These joints transmit all the forces from the upper body to the pelvis and their respective legs. Repeated trauma and aging affect this joint resulting in inflammation and arthritic changes. These changes result in misalignment of the joint or limitation to normal motion which can create pain typically very low in the back or in the buttocks,

High-Intensity Focused Ultrasound (HIFU) technology uses sound waves. These sound waves are concentrated into a specific spot in order to raise the local tissue temperature causing a burn, this burn is expected to intentionally damage the nerve causing pain.

The HIFU device used in this study is called, the Neurolyser XR. It focuses sound wave energy directly on the nerve of the painful sacroiliac joint, causing an increase in temperature, which is expected to directly damage the nerve fibers which carry pain signals to the brain.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

10 participant feasibility study

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Sacroiliitis

Intervention

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

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.

Study Arms

Experimental: HIFU for Sacroiliitis

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

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

• Publications *: 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.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: September 21, 2023): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 15, 2024
• Estimated Primary Completion Date: September 15, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Men and women aged 18 and older
2. BPI < 40
3. Patients who are able and willing to give consent and able to attend all study visits.
4. Patients who are able to communicate with the treating physician.
5. Patients must have chronic lower back pain (LBP) attributed to degenerative sacroiliitis diagnosed by a pain physician using the following guidelines:
6. At least 1 positive sacroiliac joint provocation test (Gaeslen's test, FABER (Patrick's test), and pelvic rock)
7. Back pain predominantly below L5
8. 50% 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).
9. 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)
10. Patients with NRS (0-10 scale) LBP average score ≥ 4
11. Patients with chronic LBP for at least 12 months.
12. Patients with Oswestry Disability Questionnaire (ODQ) for LBP score > 40%

Exclusion Criteria:

1. Patients on dialysis
2. 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).
3. Spinal pathology that may impede recovery such as spina bifida occulta, grade II or higher.
4. Spondylolisthesis at L5/S1, or scoliosis
5. Patients with radiofrequency ablation (RF/RFA) treatment for sacroiliitis LBP
6. Patients with bilateral sacroiliitis LBP
7. Patients with previous low back surgery
8. Patients who are pregnant
9. Patients with existing malignancy
10. Patients with allergies to relevant anesthetics
11. Patients with motor deficit or any other indication for surgical intervention
12. Patients with contraindications for MRI
13. 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.
14. Patients with unstable cardiac status including:
15. Unstable angina pectoris on medication
16. Patients with documented myocardial infarction less than 40 days prior to protocol enrolment
17. Patients with Severe Congestive Heart Failure, New York Heart Association (NYHA) class 4.
18. Patients on anti-arrhythmic drugs or with uncontrolled and/or untreated arrhythmia status
19. Patients with severe cerebrovascular disease (CVA within last 6 months)
20. Patients with severe hypertension (diastolic BP > 100 on medication)
21. Patient Body Mass Index > 45 or <20
22. Patients with known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
23. Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
24. The patient is unable to communicate with the investigator and staff.
25. Patients who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hours)
26. Patient with acute pelvic inflammatory conditions
27. Ongoing/ unresolved Worker's compensation, injury litigation, military medical board, or disability remuneration claims
28. Morphine Milligram Equivalents (MME) > 60 per 24 hrs.
29. Patients with platelets < 100.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Alexi Moruza; 434-243-5676; AM2JT@uvahealth.org

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06053255
• Other Study ID Numbers: SIJ-002
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: FUSMobile Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: FUSMobile Inc.
• Original Study Sponsor: Same as current
• Collaborators: Focused Ultrasound Foundation

Investigators

• Principal Investigator: Lynn Kohan, MD; University of Virginia Pain Medicine Clinic

• PRS Account: FUSMobile Inc.
• Verification Date: October 2023