NCT03168802

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

Comparative Study of Magnetic Resonance-guided Focused Ultrasound and Radiofrequency Ablation for Treatment of Facet-joint Osteoarthritis Low Back Pain

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Taipei Medical University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Low Back Pain
• Facet Joint Syndrome

Interventions

Type	Name	Description
PROCEDURE	MRgFUS ablation	Focus ultrasound ablation therapy under MRI navigation for facet joint syndrome.
PROCEDURE	Radiofrequency ablation	Radiofrequency ablation therapy under C-arm navigation for facet joint syndrome.

Timeline

• Start date: 2018-08-24
• Primary completion: 2025-11-25
• Completion: 2025-11-25
• First posted: 2017-05-30
• Last updated: 2024-12-05

Locations

1 site across 1 country: Taiwan