NCT03168802招募中不适用
Comparative Study of Magnetic Resonance-guided Focused Ultrasound and Radiofrequency Ablation for Treatment of Facet-joint Osteoarthritis Low Back Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pain score change: Numerical Rating Scale (NRS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
- •Patients with MRgFUS or RF treatment for LBP within the last 6 months.
- •Patients with previous low back surgery.
- •Patients who are pregnant.
- •Patients with existing malignancy.
- •Patients with allergies to relevant contrast, anesthetics, sedation drugs.
- •Patients with contraindications for MRI.
- •Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
- •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
- •Patients on anti-arrhythmic drugs or with uncontrolled and/or untreated arrhythmia status
- •Patients with pacemaker
- •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 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.)
- •Coagulation disorders or other bleeding disorders, use of anticoagulants or antiplatelet drugs within 5 days before treatment.
- •When local anesthesia or diagnostic medial nerve branch injection, the pain does not reach 75% (0.5 mL of 2% lidocaine).
结局指标
主要结局
Pain score change: Numerical Rating Scale (NRS)
时间窗: 24-week post-treatment
Efficacy
次要结局
- Adverse event(1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment)
- Functional scales change: EQ5D Quality of Life questionnaires(1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment)
- Amount of analgesic consumption(1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment)
- Pain score change: Numerical Rating Scale (NRS)(1-, 4-, 8-, 12-, 36-, 52-week post-treatment)
- Functional scales change: Oswestry Disability Questionnaire (ODQ)(1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment)
- Functional scales change: Brief Pain Inventory-Quality of Life (BPI-QoL)(1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment)
- Functional scales change: Core Outcome Measurement Index (COMI)(1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment)
研究者
Meng-Huang Wu
Principal Investigator
Taipei Medical University Hospital
研究点 (2)
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