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

Eligibility 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.