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

Inclusion criteria

• Men and women aged 18 and older
• 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%

Exclusion criteria

• 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)
• Patient with acute pelvic inflammatory conditions
• Ongoing/ unresolved Worker's compensation, injury litigation, military medical board, or disability remuneration claims
• Morphine Milligram Equivalents (MME) \> 60 per 24 hrs.
• Patients with platelets \< 100.