MRgFUS and RFA for Treatment of Facet-joint Osteoarthritis Low Back Pain (NCT03168802) | Clinical Trial Compass
RecruitingNot Applicable
MRgFUS and RFA for Treatment of Facet-joint Osteoarthritis Low Back Pain
Taiwan100 participantsStarted 2018-08-24
Plain-language 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.
Who can participate
Age range20 Years – 79 Years
SexALL
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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.