CCEF in the Treatment of Acute VFFs: Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Vertebral Fracture; Osteoporotic Fractures
• Intervention / Treatment: Device: Capacitive Coupled Electric Fields (CCEF); Other: Calssic clinical protocol

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CCEF group; 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.	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: Control Group; (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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VBME resolution in MRI	MRI of the spine	Changes of VMBE at 60 days FU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain improvement	VAS	Changes of pain at 180 days FU compared to baseline
quality of life and back pain improvement	ODI (Oswestry Disability Index)	Improvement of quality of life at 180 days FU compared to baseline

Collaborators and Investigators

• Sponsor: University of Bari Aldo Moro
• Collaborators: IGEA
• Investigators: Principal Investigator: Davide Bizzoca, MD, PhDs, AOU Policlinico di Bari

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: March 11, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: MRI; back pain; aging; osteoporosis; spine; osteopenia; fragility fractures; acute vertebral fracture; vertebral fragility fracture; vertebral bone marrow edema;; biophysical stimulation; capacitive coupled electric fields (CCEF)
• Additional Relevant MeSH Terms: Wounds and Injuries; Spinal Injuries; Back Injuries; Fractures, Bone; Spinal Fractures; Osteoporotic Fractures
• Other Study ID Numbers: CCEFVBME

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No