Clinical trial NCT05803681: CCEF in the Treatment of Acute VFFs: Randomized Controlled Trial
Official title: Capacitively Coupled Electric Fields in the Treatment of Acute Vertebral Fragility Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vertebral Fracture
Osteoporotic Fractures
Keywords: acute vertebral fracture
vertebral fragility fracture
vertebral bone marrow edema;
osteoporosis
osteopenia
fragility fractures
biophysical stimulation
capacitive coupled electric fields (CCEF)
MRI
spine
back pain
aging
Lead sponsor: University of Bari Aldo Moro
Sponsor class: OTHER
Collaborators: name: IGEA
First posted: 2023-04-07
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: in recent years the search for therapeutic protocols that could enhance the VFFs healing, thus reducing bed rest-related complications and improving the quality of life of osteoporotic patients. In this context, biophysical stimulation with Capacitively Coupling Electric Fields (CCEF) together, antiresorptive therapy, vitamin D supplementation, and analgesic drugs could play a central role.

CCEF is a non-invasive type of biophysical stimulation used to enhance fracture repair and spinal fusion. Positive effects of CCEF have been reported in osteoporotic vertebral fractures to resolve chronic pain and in postoperative pain, disability, and quality of life after spinal fusion In a preliminary observational study, Piazzolla et al. showed a significantly faster VBME resolution and back pain improvement in patients suffering from VFFs.

Detailed description: Between January 2015 and December 2020, patients referring to the spine centres participating in this multicentre randomized controlled trial with acute VFFs type OF1 or OF2 were included in the present study. Ethical clearance was obtained from our centre's clinical research ethics, as per the 1964 Declaration of Helsinki, and all patients gave informed consent before enrolment in the study.

Eligibility criteria: Inclusion Criteria:

* male and female;
* years≥ 60 years old;
* BMI ≤ 35 kg/cm2;
* fracture site between T10 and L3;
* pain at the VCF level;
* low back pain onset within twenty days;
* VBME\>60% in MRI at baseline;
* VBME in a maximum of two vertebral bodies.

Exclusion Criteria:

* posterior wall /pedicle injury;
* previous vertebroplasty/ kyphoplasty;
* history of spine infection or tuberculosis;
* history of malignant tumours that could spread to the spine;
* concomitant rheumatoid arthritis or spondylarthritis;
* scoliosis ≥ 40° according to Cobb;
* thoracolumbar kyphosis\>20° or thoracic kyphosis\>70°;
* any contraindication to MRI;
* use of biomedical devices.

Primary outcomes:
measure: VBME resolution in MRI
timeFrame: Changes of VMBE at 60 days FU
Secondary outcomes:
measure: Pain improvement
timeFrame: Changes of pain at 180 days FU compared to baseline
measure: quality of life and back pain improvement
timeFrame: Improvement of quality of life at 180 days FU compared to baseline
Other outcomes:
Locations:
Study officials:
affiliation: AOU Policlinico di Bari
name: Davide Bizzoca, MD, PhDs
role: PRINCIPAL_INVESTIGATOR
References: