72
Participants
Start Date
October 1, 2023
Primary Completion Date
July 10, 2024
Study Completion Date
November 10, 2024
Rebox-Physio 4 (real stimulation)
Rebox-Physio 4 is a CE-certified medical device class IIa. The device is a voltage-controlled generator of specific DC electric pulses with voltage amplitude 0-21 V, current intensity up to 200 uA, rectangular pulse shape, pulse frequency 3000 Hz and pulse duration 0.25 ms. Rebox currents are applied locally at the site of pain non-invasively transcutaneously with a touch of a flexible pin active treatment electrode (cathode) while the patient holds a cylindrical electrode (anode) to close electric circuit. Stimulation time in one point is 3-5 seconds until the current intensity reaches stable target values of 140-160 uA. During one session, total 20-50 points are systematically treated at a mutual distance of approx. 2 cm over the target region.
Rebox-Physio 4 (sham stimulation)
"In the sham stimulation, the comparator will be a visually identical sham version of the real Rebox-Physio 4.The sham device has a resistor installed at the output generating current of negligible intensity (maximum 1 uA) assuming no relevant physiological effect. The application procedure will be identical to the real device. When applied to the patient, the sham device displays false voltage and current intensity values and responds to the operator´s actions in real time mimicking the real stimulation. The operator is therefore blinded."
F.D. Roosevelt University Hospital, Banská Bystrica
F.D. Roosevelt University Hospital in Banská Bystrica, Slovakia
UNKNOWN
Rebox Therapy s.r.o.
INDUSTRY