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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 79
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Taiwan
Taipei medical university hospital
RECRUITING
Taipei
Contact Information
Primary
Meng-Huang Wu, MD
maxwutmu@gmail.com
227372181
Time Frame
Start Date: 2018-08-24
Estimated Completion Date: 2025-11-25
Participants
Target number of participants: 100
Treatments
Experimental: MRgFUS facet treatment
MRgFUS ablation for facet joint pain once at Lumbar spine
Active_comparator: Radiofrequency ablation facet treatment
Radiofrequency ablation for facet joint pain once at Lumbar spine
Sponsors
Leads: Taipei Medical University Hospital

This content was sourced from clinicaltrials.gov