RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Safety and Efficacy of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis

Quick Facts

Study Start:2024-09-13

Study Completion:2026-12-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06053255

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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%	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.

Inclusion Criteria

Exclusion 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%

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.

Contacts and Locations

Study Contact

Alexi Moruza

CONTACT

434-243-5676

AM2JT@uvahealth.org

Principal Investigator

Lynn Kohan, MD

PRINCIPAL_INVESTIGATOR

University of Virginia Pain Medicine Clinic

Study Locations (Sites)

University of Virginia, Department of Anesthesiology

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: FUSMobile Inc.

Lynn Kohan, MD, PRINCIPAL_INVESTIGATOR, University of Virginia Pain Medicine Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-13

Study Completion Date2026-12-15

Study Record Updates

Study Start Date2024-09-13

Study Completion Date2026-12-15

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Sacroiliitis