CCEF in the Treatment of Acute VFFs: Randomized Controlled Trial

NCT ID: NCT05803681

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2020-12-31

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.

Conditions

Vertebral Fracture; Osteoporotic Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Capacitive Coupled Electric Fields (CCEF)

Intervention Type: 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.

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.

Group Type: OTHER

Calssic clinical protocol

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IGEA

INDUSTRY

Sponsor Role: collaborator

University of Bari Aldo Moro

OTHER

Sponsor Role: lead

Responsible Party

Davide Bizzoca

MD, PhDs. PhDs in Public health, Clinical Medicine and Oncology. DiMePre-J, University of Bari

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Davide Bizzoca, MD, PhDs

Role: PRINCIPAL_INVESTIGATOR

AOU Policlinico di Bari

References

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.

Reference Type: DERIVED

PMID: 38622334 (View on PubMed)

Other Identifiers

CCEFVBME

Identifier Type: -

Identifier Source: org_study_id