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

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 Overview

• Status: Recruiting
• Conditions: Multiple Myeloma

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Mariagrazia Michieli, MD; Phone Number: 0434 659 020; Email: mmichieli@cro.it

Study Locations

• Italy
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Recruiting
      • Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
      • Contact: Mariagrazia Michieli, MD; Phone Number: 0434 659 020; Email: mmichieli@cro.it
      • Principal Investigator: Mariagrazie Michieli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from multiple myeloma (MM) with multiple vertebral lesions and candidates for vertebroplasty, consecutively diagnosed with MM in the period from 2015 to 2021 at the study center

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
MM patient candidate to vertebroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Difference in mean of energy expenditure before and after vertebroplasty	Difference in mean of energy expenditure before and after vertebroplasty	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Centro di Riferimento Oncologico - Aviano
• Investigators: Principal Investigator: Mariagrazia Michieli, MD, Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Estimated): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: CRO-2020-35

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No