MRgFUS and RFA for Treatment of Facet-joint Osteoarthritis Low Back Pain

Inclusion criteria

• Men and women age 20 to 79 years old
• Suffering from lumbar vertebral facet joint syndrome.
• Lower back pain at least six months (NRS≥4).
• Conventional treatment of pain includes NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy or chiropractic therapy.
• Imaging of the spine have facet osteoarthritis.
• Referred pain is no more below the knee.
• At least once when local anesthesia or diagnostic medial nerve branch injection, pain reduction> 75% (0.5ml of 2% lidocaine).

Exclusion criteria

• Patients with evidence of lumbosacral radiculopathy on MRI, CT or physical exam findings, including radicular leg pain.
• Patients with motor deficit or any other indication for surgical intervention.
• Patients with MRgFUS or RF treatment for LBP within the last 6 months.
• Patients with previous low back surgery.
• Patients who are pregnant.
• Patients with existing malignancy.
• Patients with allergies to relevant contrast, anesthetics, sedation drugs.
• Patients with contraindications for MRI.
• Patients with an acute medical condition (e.g., pneumonia, sepsis) 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, NYHA class 4.
• Patients on anti-arrhythmic drugs or with uncontrolled and/or untreated arrhythmia status
• Patients with pacemaker
• Patients with severe cerebrovascular disease (CVA within last 6 months)
• Patients with severe hypertension (diastolic BP > 100 on medication)
• Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
• Patients 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 hrs.)
• Coagulation disorders or other bleeding disorders, use of anticoagulants or antiplatelet drugs within 5 days before treatment.
• When local anesthesia or diagnostic medial nerve branch injection, the pain does not reach 75% (0.5 mL of 2% lidocaine).