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RecruitingNCT06255639Updated Feb 13, 2024

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

An observational study in Multiple Myeloma, sponsored by Centro di Riferimento Oncologico - Aviano. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-13.

Sponsored by Centro di Riferimento Oncologico - Aviano · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Oct 2020; still recruiting 5 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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

02

Conditions studied

03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 20 is below the median of 140 across 468 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Centro di Riferimento Oncologico - Aviano is the lead sponsor of 47 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • MM patient candidate to vertebroplasty
06

What researchers measure

Primary outcomes

  1. Difference in mean of kinematic data for walking before and after vertebroplasty

    Difference in mean of kinematic data for walking before and after vertebroplasty

    Time frame: 2 months

  2. 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

    Time frame: 2 months

  3. Difference in mean of energy expenditure before and after vertebroplasty

    Difference in mean of energy expenditure before and after vertebroplasty

    Time frame: 2 months

Secondary outcomes

  1. 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

    Time frame: 2 months

  2. 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.

    Time frame: 2 months

  3. 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.

    Time frame: 2 months

  4. 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.

    Time frame: 2 months

  5. 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

    Time frame: 2 months

07

Study locations

1 of 1 sites recruiting
  • Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
    Aviano, Pordenone 33081, Italy
    • Mariagrazia Michieli, MD · Contact · mmichieli@cro.it · 0434 659 020
    • Mariagrazie Michieli, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06255639
Lead sponsor
Centro di Riferimento Oncologico - Aviano
Responsible party
Sponsor
First posted
Feb 13, 2024
Start date
Oct 15, 2020
Primary completion
Oct 2024 (estimated)
Completion
Oct 2024 (estimated)
Last update
Feb 13, 2024

Study contacts

Mariagrazia Michieli, MD
Contact
mmichieli@cro.it
0434 659 020
Mariagrazia Michieli, MD
principal investigator · Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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