NCT03168802 MRgFUS and RFA for Treatment of Facet-joint Osteoarthritis Low Back Pain
| NCT ID | NCT03168802 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Taipei Medical University Hospital |
| Condition | Chronic Low Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2018-08-24 |
| Primary Completion | 2025-11-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2018-08-24 with a primary completion date of 2025-11-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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).
Contact & Investigator
Yen Yun, PhD
STUDY CHAIR
Taipei Medical University
Frequently Asked Questions
Who can join the NCT03168802 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 79 Years, studying Chronic Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03168802 currently recruiting?
Yes, NCT03168802 is actively recruiting participants. Contact the research team at maxwutmu@gmail.com for enrollment information.
Where is the NCT03168802 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT03168802 clinical trial?
NCT03168802 is sponsored by Taipei Medical University Hospital. The principal investigator is Yen Yun, PhD at Taipei Medical University. The trial plans to enroll 100 participants.