MRgFUS and RFA for Treatment of Facet-joint Osteoarthritis Low Back Pain
Recruiting · NCT03168802 · Interventional (participants receive a specific treatment) · Lead sponsor: Taipei Medical University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This is a prospective, randomized, two-arm, phase II study. The purpose of this study is: * To evaluate and compare the efficacy and safety of magnetic resonance-guided focused ultrasound (MRgFUS) and radiofrequency ablation (RFA) for treatment of facet-joint osteoarthritis low back pain. * Determining the effect of the MRgFUS System and RFA for improving functional disabilities and in reducing pain resulting from facet-joint osteoarthritis low back pain. Efficacy will be determined by the level of pain relief (as measured by the Numerical Rating Scale, NRS), decrease in analgesics/opiate, improved quality of life (as measured by the Oswestry Disability Questionnaire, ODQ, and core outcome measures index questionnaire, COMI), pain interference with function (as measured by the Brief Pain Inventory-Interference scale, BPI-QoL), general health status (as measured by the EQ5D), physical exam, X-ray and MRI studies from baseline up to 12-Months post- MRgFUS and radiofrequency treatment. * Evaluate incidence and severity of adverse events associated with the MRgFUS system and RFA used for the treatment of pain resulting from facet-joint osteoarthritis low back pain.
Who can take part
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).
Where it is running
1 location listed.
- Taipei medical university hospital - Taipei, Please Select, Taiwan