CCEF in the Treatment of Acute VFFs: Randomized Controlled Trial

Vertebral Fracture Clinical Trial

Official title:

Capacitively Coupled Electric Fields in the Treatment of Acute Vertebral Fragility Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05803681
• Other study ID #: CCEFVBME
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2023
• Source: University of Bari Aldo Moro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporotic Fractures
• Spinal Fractures
• Vertebral Fracture

Intervention

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Bari Aldo Moro	IGEA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VBME resolution in MRI	MRI of the spine	Changes of VMBE at 60 days FU
Secondary	Pain improvement	VAS	Changes of pain at 180 days FU compared to baseline
Secondary	quality of life and back pain improvement	ODI (Oswestry Disability Index)	Improvement of quality of life at 180 days FU compared to baseline