Clinical trial NCT06255639: Biomechanical and Metabolic Assessment Pre and Post Vertebroplasty in Multiple Myeloma Patients With Vertebral Collapse
Official title: Biomechanical and Metabolic Assessment Pre and Post Vertebroplasty in Multiple Myeloma Patients With Vertebral Collapse
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Lead sponsor: Centro di Riferimento Oncologico - Aviano
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: 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

Primary outcomes:
measure: Difference in mean of kinematic data for walking before and after vertebroplasty
timeFrame: 2 months
measure: difference in mean of movement range for affected joints before and after vertebroplasty
timeFrame: 2 months
measure: Difference in mean of energy expenditure before and after vertebroplasty
timeFrame: 2 months
Secondary outcomes:
measure: To explore the impact of vertebroplasty on thermal parameters
timeFrame: 2 months
measure: To explore the impact of vertebroplasty on metabolic parameters
timeFrame: 2 months
measure: To explore the impact of vertebroplasty on metabolic parameters
timeFrame: 2 months
measure: To explore the impact of vertebroplasty on metabolic parameters
timeFrame: 2 months
measure: To explore the impact of vertebroplasty on pain
timeFrame: 2 months
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
state: Pordenone
Study officials:
affiliation: Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
name: Mariagrazia Michieli, MD
role: PRINCIPAL_INVESTIGATOR
References: