Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis
Recruiting now · Not applicable
Conditions studied: Sacroiliitis
In brief
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.
Key facts
- Study ID
- NCT06053255
- Run by
- FUSMobile Inc.
- People needed
- 10
- Starts
- 2024-09-13
- Expected to finish
- 2026-12-15
- Last updated by the study team
- 2025-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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).
- 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
- Patients with documented myocardial infarction less than 40 days prior to protocol enrolment
- Patients with Severe Congestive Heart Failure, New York Heart Association (NYHA) class 4.
- Patients on anti-arrhythmic drugs or with uncontrolled and/or untreated arrhythmia status
- Patients with severe cerebrovascular disease (CVA within last 6 months)
- Patients with severe hypertension (diastolic BP > 100 on medication)
- Patient Body Mass Index > 45 or <20
- Patients with known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
- Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
- The patient is unable to communicate with the investigator and staff.
- Patients who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hours)
Where it is running
- University of Virginia, Department of Anesthesiology — Charlottesville, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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