Multiple Myeloma
Conditions
Brief summary
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
Detailed description
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
Interventions
None listed
Sponsors
Centro di Riferimento Oncologico - Aviano
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* presence of spinal cord compressions; * unstable spinal injuries, requiring an orthopaedic back brace; * risk of spinal cord injury; * body mass index BMI\>28 kg/m2. * absence of signed informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in mean of kinematic data for walking before and after vertebroplasty | 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 | 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 | 2 months | Difference in mean of energy expenditure before and after vertebroplasty |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To explore the impact of vertebroplasty on thermal parameters | 2 months | Central and superficial temperature will be measured before and after vertebroplasty. Difference will be reported as intrapatient mean difference |
| To explore the impact of vertebroplasty on metabolic parameters | 2 months | Carbon dioxide production after 30 minutes of walking will be measured before and after vertebroplasty and intrapatient mean difference will be reported. |
| To explore the impact of vertebroplasty on pain | 2 months | Perceived pain will be measured using the Brief Pain Inventory scale (BPI) before and after vertebroplasty. Difference will be reported as intrapatient mean difference. BPI values range between 0 and 10, with higher scores meaning worst pain |
Countries
Italy
Contacts
Primary ContactMariagrazia Michieli, MD
Outcome results
None listed