MRgFUS and RFA for Treatment of Facet-joint Osteoarthritis Low Back Pain
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- 20 és 79 év között vagy?
Forrás: NCT03168802: ki vehet részt
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Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Taipei Medical University Hospital
- Azonosító
- NCT03168802
- A regiszteradat frissítve
- 2024. december 5.
- Eredeti leírás
This is a prospective, randomized, two-arm, phase II study.A teljes eredeti leírásKevesebb
Comparative Study of Magnetic Resonance-guided Focused Ultrasound and Radiofrequency Ablation for Treatment of Facet-joint Osteoarthritis Low Back Pain
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.
Bevonási feltételek: 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).
Kizáró feltételek: Patients with motor deficit or any other indication for surgical intervention; Patients with previous low back surgery; 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; Coagulation disorders or other bleeding disorders, use of anticoagulants or antiplatelet drugs within 5 days before treatment; Patients with existing malignancy; Patients with allergies to relevant contrast, anesthetics, sedation drugs; Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study; 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 with evidence of lumbosacral radiculopathy on MRI, CT or physical exam findings, including radicular leg pain; Patients with MRgFUS or RF treatment for LBP within the last 6 months; Patients who are pregnant; Patients with contraindications for MRI; 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.); When local anesthesia or diagnostic medial nerve branch injection, the pain does not reach 75% (0.5 mL of 2% lidocaine).