70
Participants
Start Date
January 1, 2015
Primary Completion Date
November 30, 2020
Study Completion Date
December 31, 2020
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.
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.
University of Bari Aldo Moro
OTHER
IGEA
INDUSTRY