Vertebral FractureNCT05803681
CCEF in the Treatment of Acute VFFs: Randomized Controlled Trial
A study testing Capacitive Coupled Electric Fields (CCEF) and Calssic clinical protocol in people with Vertebral Fracture and Osteoporotic Fractures, run by University of Bari Aldo Moro.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Vertebral Fracture, Osteoporotic Fractures
- What is being tested?
- Capacitive Coupled Electric Fields (CCEF) and Calssic clinical protocol
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- thoracolumbar kyphosis>20° or thoracic kyphosis>70°;
- any contraindication to MRI;
- use of biomedical devices.
About this study
Official title: Capacitively Coupled Electric Fields in the Treatment of Acute Vertebral Fragility Fractures
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.
Read the 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.
- Conditions
- Vertebral Fracture, Osteoporotic Fractures
- Being tested
- Capacitive Coupled Electric Fields (CCEF), Calssic clinical protocol
- 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
- Medical subject headings
- Spinal Fractures, Osteoporotic Fractures, Osteoporosis, Bone Diseases, Metabolic, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capacitive Coupled Electric Fields (CCEF)Device
In the CCEF Group, patients received, as an adjunct to the clinical study protocol, CCEF stimulation (Osteospine®, IGEA SpA, Carpi, Italy) 8 h/die for sixty days.
Calssic clinical protocolOther
(1) bed rest for the first twenty-five days and subsequent mobilization with a three-point hyperextension brace; (2) antiresorptive therapy (75 mg risedronate tablet weekly); (3) supplemental calcium carbonate with 1000 mg of elemental calcium daily if needed based on serum calcium concentration; (4) Vitamin D (≤500 IU daily) if the serum 25-hydroxyvitamin D concentration at the time of screening was below 16 ng/ml). Analgesic therapy with paracetamol 1000mg tablets was assumed for seven days and further depending on pain intensity; patients were required to report on a specific sheet paracetamol assumption.
| Study group | Role | What they receive |
|---|---|---|
| CCEF group | Experimental | In the CCEF Group, patients received, as an adjunct to the clinical study protocol, CCEF stimulation (Osteospine®, IGEA SpA, Carpi, Italy) 8 h/die for sixty days.
Clinical study protocol: (1) bed rest for the first twenty-five days and subsequent mobilization with a three-point hyperextension brace; (2) antiresorptive therapy (75 mg risedronate tablet weekly); (3) supplemental calcium carbonate with 1000 mg of elemental calcium daily if needed based on serum calcium concentration; (4) Vitamin D (≤500 IU daily) if the serum 25-hydroxyvitamin D concentration at the time of screening was below 16 ng/ml). Analgesic therapy with paracetamol 1000mg tablets was assumed for seven days and further depending on pain intensity; patients were required to report on a specific sheet paracetamol assumption. Receives: Device: Capacitive Coupled Electric Fields (CCEF) |
| Control Group | Other | (1) bed rest for the first twenty-five days and subsequent mobilization with a three-point hyperextension brace; (2) antiresorptive therapy (75 mg risedronate tablet weekly); (3) supplemental calcium carbonate with 1000 mg of elemental calcium daily if needed based on serum calcium concentration; (4) Vitamin D (≤500 IU daily) if the serum 25-hydroxyvitamin D concentration at the time of screening was below 16 ng/ml). Analgesic therapy with paracetamol 1000mg tablets was assumed for seven days and further depending on pain intensity; patients were required to report on a specific sheet paracetamol assumption. Receives: Other: Calssic clinical protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
VBME resolution in MRI
MRI of the spine
Measured: Changes of VMBE at 60 days FU
Secondary outcomes (2)
Pain improvement
VAS
Measured: Changes of pain at 180 days FU compared to baseline
quality of life and back pain improvement
ODI (Oswestry Disability Index)
Measured: Improvement of quality of life at 180 days FU compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Jan 2015
- Primary completion30 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vertebral FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari Aldo Moro
- Sponsor type
- University, hospital or other
- Collaborators
- IGEA
- Responsible party
- Principal investigator, Davide Bizzoca, University of Bari Aldo Moro
- Investigators
- Davide Bizzoca, MD, PhDs, Principal investigator, AOU Policlinico di Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803681
- Sponsor's protocol ID
- CCEFVBME
- Status last verified
- Mar 2023
- First submitted
- 11 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Piazzolla A, Bizzoca D, Barbanti-Brodano G, Formica M, Pietrogrande L, Tarantino U, Setti S, Moretti B, Solarino G. Capacitive biophysical stimulation improves the healing of vertebral fragility fractures: a prospective multicentre randomized controlled trial. J Orthop Traumatol. 2024 Apr 15;25(1):17. doi: 10.1186/s10195-024-00758-2.
PubMed 38622334
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capacitively Coupled Electric Fields in the Treatment of Acute Vertebral Fragility Fractures
- ClinicalTrials.gov ID
- NCT05803681
- Acronym / sponsor ID
- CCEFVBME
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Bari Aldo MoroUniversity, hospital or other
- Collaborators
- IGEA
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCEF group | Experimental | Device: Capacitive Coupled Electric Fields (CCEF)In the CCEF Group, patients received, as an adjunct to the clinical study protocol, CCEF stimulation (Osteospine®, IGEA SpA, Carpi, Italy) 8 h/die for sixty days. Clinical study protocol: (1) bed rest for the first twenty-five days and subsequent mobilization with a three-point hyperextension brace; (2) antiresorptive therapy (75 mg risedronate tablet weekly); (3) supplemental calcium carbonate with 1000 mg of elemental calcium daily if needed based on serum calcium concentration; (4) Vitamin D (≤500 IU daily) if the serum 25-hydroxyvitamin D concentration at the time of screening was below 16 ng/ml). Analgesic therapy with paracetamol 1000mg tablets was assumed for seven days and further depending on pain intensity; patients were required to report on a specific sheet paracetamol assumption. |
| Control Group | Other | Other: Calssic clinical protocol(1) bed rest for the first twenty-five days and subsequent mobilization with a three-point hyperextension brace; (2) antiresorptive therapy (75 mg risedronate tablet weekly); (3) supplemental calcium carbonate with 1000 mg of elemental calcium daily if needed based on serum calcium concentration; (4) Vitamin D (≤500 IU daily) if the serum 25-hydroxyvitamin D concentration at the time of screening was below 16 ng/ml). Analgesic therapy with paracetamol 1000mg tablets was assumed for seven days and further depending on pain intensity; patients were required to report on a specific sheet paracetamol assumption. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- male and female;
- years≥ 60 years old;
- BMI ≤ 35 kg/cm2;
- fracture site between T10 and L3;
- pain at the VCF level;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capacitive Coupled Electric Fields (CCEF)In the CCEF Group, patients received, as an adjunct to the clinical study protocol, CCEF stimulation (Osteospine®, IGEA SpA, Carpi, Italy) 8 h/die for sixty days. | Device | CCEF group |
| Calssic clinical protocol(1) bed rest for the first twenty-five days and subsequent mobilization with a three-point hyperextension brace; (2) antiresorptive therapy (75 mg risedronate tablet weekly); (3) supplemental calcium carbonate with 1000 mg of elemental calcium daily if needed based on serum calcium concentration; (4) Vitamin D (≤500 IU daily) if the serum 25-hydroxyvitamin D concentration at the time of screening was below 16 ng/ml). Analgesic therapy with paracetamol 1000mg tablets was assumed for seven days and further depending on pain intensity; patients were required to report on a specific sheet paracetamol assumption. | Other | Control Group |
Primary outcome
VBME resolution in MRI
Time frame: Changes of VMBE at 60 days FU
MRI of the spine
2 secondary outcomes
Pain improvement
Time frame: Changes of pain at 180 days FU compared to baseline
quality of life and back pain improvement
Time frame: Improvement of quality of life at 180 days FU compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Derived from this study: PubMed 38622334Piazzolla A, Bizzoca D, Barbanti-Brodano G, Formica M, Pietrogrande L, Tarantino U, Setti S, Moretti B, Solarino G. Capacitive biophysical stimulation improves the healing of vertebral fragility fractures: a prospective multicentre randomized controlled trial. J Orthop Traumatol. 2024 Apr 15;25(1):17. doi: 10.1186/s10195-024-00758-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davide Bizzoca, MD, PhDs principal investigator
AOU Policlinico di Bari
Questions about this trial
What is this clinical trial studying?
A study testing Capacitive Coupled Electric Fields (CCEF) and Calssic clinical protocol in people with Vertebral Fracture and Osteoporotic Fractures, run by University of Bari Aldo Moro.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VBME resolution in MRI (time frame: Changes of VMBE at 60 days FU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05803681, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.