28
Participants
Start Date
August 1, 2023
Primary Completion Date
July 1, 2026
Study Completion Date
June 1, 2027
I-One
"I-ONE® is a medical device certified by the Ministry of Health as a Medical Device (risk class II A) for the treatment of inflammatory and degenerative tissue pathologies. The device consists of a signal generator and an applicator, called a solenoid. The solenoid will be placed on the joint, not necessarily in direct contact with the skin. The device works with a rechargeable battery and is equipped with an hour counter to assess patient compliance.~Treatment with I-ONE® therapy will start within 3-7 days of recruitment, will last 6 hours a day and will be maintained for 60 days. The treatment will be carried out at home and the device will be delivered directly to the patient's home by courier."
RECRUITING
Angela Notarnicola, Bari
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
OTHER