Biomechanical and Metabolic Assessment Pre and Post Vertebroplasty in Multiple Myeloma Patients With Vertebral Collapse
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Difference in mean of kinematic data for walking before and after vertebroplasty
研究概览
简要总结
In patients with Multiple Myeloma (MM), bone lesions can lead to multiple vertebral lesions, with vertebral collapses. The introduction of minimally invasive procedures such as percutaneous vertebroplasty allow patients to return to a fair level of function and a significant reduction in pain. Despite medical therapies, radiotherapy, analgesics and vertebroplasty procedures, patients with multiple spinal injuries often complain of pain and stiffness that limit their mobility, daily activities and work. The aim of this study is to measure how the biomechanical, thermo-metabolic and algic parameters change after vertebroplasty in patients with MM
详细描述
In patients with Multiple Myeloma (MM), bone lesions can lead to multiple vertebral lesions, with vertebral collapses. The introduction of minimally invasive procedures such as percutaneous vertebroplasty allow patients to return to a fair level of function and a significant reduction in pain. Despite medical therapies, radiotherapy, analgesics and vertebroplasty procedures, patients with multiple spinal injuries often complain of pain and stiffness that limit their mobility, daily activities and work. The aim of this study is to measure how the biomechanical, thermo-metabolic and algic parameters change after vertebroplasty in patients with MM
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥ 18 years;
- •Diagnosis of multiple myeloma;
- •Clinical indication and eligibility for vertebroplasty procedure;
- •Performance Status (ECOG) 0-2;
- •Life expectancy greater than three months;
- •Low-resolution full skeletal CT scan at disease onset and/or at follow-up;
- •Spine pain with stiffness and functional impediment pre vertebroplasty;
- •Able to express appropriate consent for participation in the study (e.g. Able to understand Italian, patient with intact cognitive abilities)
排除标准
- •presence of spinal cord compressions;
- •unstable spinal injuries, requiring an orthopaedic back brace;
- •risk of spinal cord injury;
- •body mass index BMI>28 kg/m
- •absence of signed informed consent form
结局指标
主要结局
Difference in mean of kinematic data for walking before and after vertebroplasty
时间窗: 2 months
Difference in mean of kinematic data for walking before and after vertebroplasty
difference in mean of movement range for affected joints before and after vertebroplasty
时间窗: 2 months
difference in mean of movement range for affected joints before and after vertebroplasty
Difference in mean of energy expenditure before and after vertebroplasty
时间窗: 2 months
Difference in mean of energy expenditure before and after vertebroplasty
次要结局
- To explore the impact of vertebroplasty on thermal parameters(2 months)
- To explore the impact of vertebroplasty on metabolic parameters(2 months)
- To explore the impact of vertebroplasty on pain(2 months)