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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06255639
• Other study ID #: CRO-2020-35
• Status: Recruiting
• Start date: October 15, 2020
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Centro di Riferimento Oncologico - Aviano
• Contact: Mariagrazia Michieli, MD
• Phone: 0434 659 020
• Email: mmichieli[@]cro.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Locations

Country	Name	City	State
Italy	Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS	Aviano	Pordenone

Sponsors (1)

Lead Sponsor	Collaborator
Centro di Riferimento Oncologico - Aviano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in mean of kinematic data for walking before and after vertebroplasty	Difference in mean of kinematic data for walking before and after vertebroplasty	2 months
Primary	difference in mean of movement range for affected joints before and after vertebroplasty	difference in mean of movement range for affected joints before and after vertebroplasty	2 months
Primary	Difference in mean of energy expenditure before and after vertebroplasty	Difference in mean of energy expenditure before and after vertebroplasty	2 months
Secondary	To explore the impact of vertebroplasty on thermal parameters	Central and superficial temperature will be measured before and after vertebroplasty. Difference will be reported as intrapatient mean difference	2 months
Secondary	To explore the impact of vertebroplasty on metabolic parameters	Carbon dioxide production after 30 minutes of walking will be measured before and after vertebroplasty and intrapatient mean difference will be reported.	2 months
Secondary	To explore the impact of vertebroplasty on metabolic parameters	Cardiac frequency after 30 minutes of walking will be measured before and after vertebroplasty and intrapatient mean difference will be reported.	2 months
Secondary	To explore the impact of vertebroplasty on metabolic parameters	Oxygen consumption after 30 minutes of walking will be measured before and after vertebroplasty and intrapatient mean difference will be reported.	2 months
Secondary	To explore the impact of vertebroplasty on pain	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	2 months