Biomechanical and Metabolic Assessment Pre and Post Vertebroplasty in Multiple Myeloma Patients With Vertebral Collapse

Recruiting

• Conditions: Multiple Myeloma

• Registration Number: NCT06255639
• Lead Sponsor: Centro di Riferimento Oncologico - Aviano

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

Study Timeline

• Study Start: 2020-10-15
• Study First Submitted: 2024-01-19
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Study First Posted: 2024-02-13
• Last Update Posted: 2024-02-13
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	Oxygen consumption 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

Trial Locations

Locations (1)

Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS; 🇮🇹 Aviano, Pordenone, Italy