CCEF in the Treatment of Acute VFFs: Randomized Controlled Trial (NCT05803681) | Clinical Trial Compass
CompletedNot Applicable
CCEF in the Treatment of Acute VFFs: Randomized Controlled Trial
70 participantsStarted 2015-01-01
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.