CCEF in the Treatment of Acute VFFs: Randomized Controlled Trial

NACompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

January 1, 2015

Primary Completion Date

November 30, 2020

Study Completion Date

December 31, 2020

Conditions
Vertebral FractureOsteoporotic Fractures
Interventions
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.

All Listed Sponsors
lead

University of Bari Aldo Moro

OTHER

collaborator

IGEA

INDUSTRY

NCT05803681 - CCEF in the Treatment of Acute VFFs: Randomized Controlled Trial | Biotech Hunter | Biotech Hunter