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NCT Number: NCT05803681

CCEF in the Treatment of Acute VFFs: Randomized Controlled Trial

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.

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Key information

Conditions

Vertebral Fracture Back Injuries Back Pain Bone Diseases Bone Diseases, Metabolic Fractures, Bone Metabolic Diseases Musculoskeletal Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Osteoporosis Osteoporotic Fractures Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Fractures Spinal Injuries Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. VBME resolution in MRI

    Time frame: Changes of VMBE at 60 days FU

    MRI of the spine

Secondary outcomes

  1. Pain improvement

    Time frame: Changes of pain at 180 days FU compared to baseline

    VAS

  2. quality of life and back pain improvement

    Time frame: Improvement of quality of life at 180 days FU compared to baseline

    ODI (Oswestry Disability Index)

Sponsors and collaborators

Lead sponsor

University of Bari Aldo Moro

Other

Collaborators

  • IGEA

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 7, 2023
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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