Assessing changes in pain and function after vertebroplasty in multiple myeloma patients
Biomechanical and Metabolic Assessment Pre and Post Vertebroplasty in Multiple Myeloma Patients With Vertebral Collapse
This study is testing how a procedure called vertebroplasty can help people with multiple myeloma feel less pain and improve their ability to move after their spine has collapsed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro di Riferimento Oncologico - Aviano Academic / other |
| Locations | 1 site (Aviano, Pordenone) |
| Trial ID | NCT06255639 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with Multiple Myeloma who experience vertebral collapses due to bone lesions. It aims to evaluate the changes in biomechanical, thermo-metabolic, and pain parameters before and after undergoing a minimally invasive procedure called vertebroplasty. The study includes patients who are clinically indicated for vertebroplasty and have specific performance status and life expectancy criteria. By measuring these parameters, the study seeks to provide insights into the effectiveness of vertebroplasty in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of Multiple Myeloma and clinical indications for vertebroplasty.
Not a fit: Patients with spinal cord compressions, unstable spinal injuries, or a body mass index over 28 kg/m2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and functional recovery for patients with Multiple Myeloma experiencing vertebral collapses.
How similar studies have performed: While similar studies have explored vertebroplasty in various contexts, this specific assessment of biomechanical and metabolic changes in Multiple Myeloma patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aviano, Pordenone
- Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS — Aviano, Pordenone, Italy (Recruiting)
Study contacts
- Principal investigator: Mariagrazia Michieli, MD — Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
- Study coordinator: Mariagrazia Michieli, MD
- Email: mmichieli@cro.it
- Phone: 0434 659 020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.