Magnetic Resonance Guided Focused Ultrasound Surgery: a Pilot Study in the Treatment of Pain Caused by Osteoarthritis - Hand and Hip, Challenging Joints
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Changes in Pain Intensity from Baseline
研究概览
简要总结
This project aims at performing a pilot study to provide data on safety and potential efficacy of Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) in the treatment of pain caused by trapeziometacarpal osteoarthritis (OA) and/or scaphotrapezial OA, and by hip OA, while exploring the potential application of MRgFUS to two different and central joints burdened by OA.
详细描述
Pain caused by osteoarthritis is a matter of huge impact, in terms of quality of life, social and economic burden. Global aging of the population is going to worsen the problem. The hand is the most affected site in the upper limb, and involvement of the trapeziometacarpal joint is highly prevalent, with significant limitation of functionality when it happens. In the lower limb, the hip and the knee share the leading position in the clinical scenario, with the former being historically the most frequently submitted to joint replacement.
At any site, the vast majority of joint replacement surgery procedures are performed because of pain. MRgFUS has recently demonstrated a great potential in treating pain caused by different medical conditions, including osteoarthritis. The aim of the work is to study the feasibility, the safety and the potential efficacy of MRgFUS in treating pain from osteoarthritis in two "hot" spots: the hip and the trapeziometacarpal/scaphotrapezial joint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female aged between 45 and 90 years
- •Presence of activity-related joint pain
- •Patients who have either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes
- •Patients who have not responded to previous treatments,
- •Patients with a baseline pain intensity of 4 to 8 on a 10-cm VAS
- •Patients who are not candidates for immediate surgery
- •Signed statement of informed consent (approved by Ethics Committee)
排除标准
- •Prior surgery or previous local treatment (infiltration, other) in the past 3 months
- •Changes in medications used during the previous 2 months
- •Intravenous drug use
- •Corticosteroid use of more than 3 months within the preceding year
- •Diagnosis of other rheumatologic disorders
- •Trauma, fracture, or osteomyelitis of the investigated joints within the preceding year
- •Any neurological disease or disorders potentially affecting pain perception
- •Fibromyalgia
- •Pregnancy
- •Patients with large scar at skin or deeper soft tissue potentially included in the planned path of the ultrasound beam
- •General contraindications to MRI and/or to anaesthesiological procedures planned for the patient
- •Presence of internal hardware or devices potentially affecting MR thermometry
结局指标
主要结局
Changes in Pain Intensity from Baseline
时间窗: Baseline (Day1), Week 1, 2, 3, Month 1, 2, 3, 6, 9, 12
Changes in pain intensity from baseline will be determined by a straight horizontal 10-cm linear Visual Analog Pain Scale (VAS, scale 0-10 where 0 means 'no pain at all' and 10 means 'pain as bad as it could be').
Incidence of Treatment-Related Adverse Events (Safety and Tolerability)
时间窗: Through study completion, an average of 1 year
Collecting the number of treatment-related adverse events
次要结局
未报告次要终点