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

Launched by TAIPEI MEDICAL UNIVERSITY HOSPITAL · May 24, 2017

Keywords

ClinConnect Summary

This clinical trial is studying two treatments for chronic low back pain caused by arthritis in the facet joints, which are small joints in the spine. The trial aims to compare the effectiveness and safety of two methods: magnetic resonance-guided focused ultrasound (MRgFUS) and radiofrequency ablation (RFA). Both treatments are designed to relieve pain and improve daily functioning for people suffering from this type of back pain. Researchers will look at how much pain relief participants experience, their ability to perform daily activities, and any side effects from the treatments over a period of up to 12 months.

To be eligible for this trial, participants should be men or women aged 20 to 79 who have been experiencing lower back pain for at least six months. They should have tried other treatments, such as pain medications or physical therapy, without sufficient relief. Some important factors that would exclude someone from participating include a recent back surgery, certain medical conditions like severe heart or lung issues, or if they are pregnant. Participants in the trial can expect to undergo the treatment and follow-up assessments to monitor their pain levels and overall health. This study is currently recruiting, so it's a good opportunity for those seeking new options for managing their back pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Men and women age 20 to 79 years old
• • 2. Suffering from lumbar vertebral facet joint syndrome.
• • 3. Lower back pain at least six months (NRS≥4).
• • 4. Conventional treatment of pain includes NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy or chiropractic therapy.
• • 5. Imaging of the spine have facet osteoarthritis.
• • 6. Referred pain is no more below the knee.
• • 7. At least once when local anesthesia or diagnostic medial nerve branch injection, pain reduction\> 75% (0.5ml of 2% lidocaine).
• Exclusion Criteria:
• • 1. Patients with evidence of lumbosacral radiculopathy on MRI, CT or physical exam findings, including radicular leg pain.
• • 2. Patients with motor deficit or any other indication for surgical intervention.
• • 3. Patients with MRgFUS or RF treatment for LBP within the last 6 months.
• • 4. Patients with previous low back surgery.
• • 5. Patients who are pregnant.
• • 6. Patients with existing malignancy.
• • 7. Patients with allergies to relevant contrast, anesthetics, sedation drugs.
• • 8. Patients with contraindications for MRI.
• • 9. Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
• 10. 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
• • 11. Patients with severe cerebrovascular disease (CVA within last 6 months)
• • 12. Patients with severe hypertension (diastolic BP \> 100 on medication)
• • 13. Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
• • 14. Patients unable to communicate with the investigator and staff.
• • 15. Patients who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.)
• • 16. Coagulation disorders or other bleeding disorders, use of anticoagulants or antiplatelet drugs within 5 days before treatment.
• • 17. When local anesthesia or diagnostic medial nerve branch injection, the pain does not reach 75% (0.5 mL of 2% lidocaine).