CCEF in the Treatment of Acute VFFs: Randomized Controlled Trial

NCT05803681 | Completed

• 1 other identifier: CCEFVBME
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

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); MRI; spine; back pain; aging

Outcome Measures

Primary Outcomes (1)

• VBME resolution in MRI

  MRI of the spine

  Changes of VMBE at 60 days FU

Secondary Outcomes (2)

• Pain improvement

  Changes of pain at 180 days FU compared to baseline

• quality of life and back pain improvement

  Improvement of quality of life at 180 days FU compared to baseline

Study Arms (2)

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.

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.

Other: Calssic clinical protocol

Interventions

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.

CCEF group

Calssic clinical protocol 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.

Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bari Aldo Moro: lead
• IGEA: collaborator

Related Publications (1)

• 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.

  PMID: 38622334 DERIVED

MeSH Terms

Conditions

Spinal Fractures; Osteoporotic Fractures; Osteoporosis; Bone Diseases, Metabolic; Back Pain

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Davide Bizzoca, MD, PhDs

  AOU Policlinico di Bari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhDs. PhDs in Public health, Clinical Medicine and Oncology. DiMePre-J, University of Bari

Study Record Dates

• First Submitted: March 11, 2023
• First Posted: April 7, 2023
• Study Start: January 1, 2015
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2020
• Last Updated: April 7, 2023

Record last verified: 2023-03