Examination of Vertebroplasty in Addition to Regular Treatment of Patients With Multiple Myeloma.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSpine Centre of Southern Denmark
About this trial
Patients with newly diagnosed or known multiple myeloma with newly diagnosed vertebral lesion(s) will be invited to participate in a cross-sectoral randomized controlled trial. The trial will compare two groups of patients which either receive regular medical treatment of their vertebral lesion(s) or vertebroplasty in addition to regular medical treatment. Our goal is to investigate the effectiveness of vertebroplasty and determine the role of surgical treatment in the overall treatment of patients with multiple myeloma and vertebral lesion(s).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
known multiple myeloma
verified lesion(s) between Th6-L5
4 or less fractures
relevant pain in 3 months or less
Disqualifiers
presence of neurologic deficit
psychological or psychiatric disorder hat is expected to interfere with compliance
Trial design
Design model
Crossover
Treatments tested in this trial
Vertebroplasty
Procedure/SurgeryInjection of cement into vertebral lesion(s)
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: VertebroplastyActive comparator 1 intervention
Group B: Regular treatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Improvement in back-specific disability
Oswestry Disability Index v2.1 (ODI): Each section is scored on a 0-5 scale, with 5 representing the highest disability.
Time frame
4 weeks post-initiation of treatmentSecondary outcomes
1
Improvement in back-specific disability
ODI
Time frame
Up to 12 months post-initiation of treatment2
Back and leg pain
Visual Analogue Scale (VAS): 0-100 scale, with 100 representing the largest amount of pain
Time frame
Up to 12 months post-initiation of treatment3
Movement, personal care, usual activities, pain/discomfort, depression/anxiety
Self-reported questionnaire on quality of life using: \- European Quality of Life - 5 Dimension (EQ-5D): 0-2 scale, with 2 representing the highest disability EQ-5D contains questions on topics contributing to the overall feeling of quality of life: * movement * personal care * usual activities (ex. occupation, family activities) * pain/discomfort * depression/anxiety.
Time frame
Up to 12 months post-initiation of treatment4
Long-term stability of treated vertebra(e)
X-rays will be used to analyze long-term stability.
Time frame
12 months post-initiation of treatmentSponsors and contacts
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Source ClinicalTrials.gov