NCT05922618

Pulsed Electromagnetic Fields (PEMFS) in Complex Regional Pain Syndrome Type i (CRPS-I) of the Foot (PeCFoA)

PEMFS in Patients With CRPS-I of the Foot and Ankle: a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesize that the association of I-ONE® therapy with standard rehabilitation treatment can optimize the clinical and functional recovery of patients with pulsed electromagnetic fields (PEMFs) (I-ONE® therapy) of the foot or ankle.

Detailed description

Study design; spontaneous, prospective, randomized study with control group. Purpose of the study: evaluate the functional clinical improvement of the foot/ankle joint with algodystrophic pathology following a standard rehabilitation treatment and home biophysical treatment and local biophysical stimulation with I-ONE® therapy (IGEA SpA).

Conditions

• Pain, Joint
• Complex Regional Pain Syndromes
• Ankle Disease
• Foot Diseases

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-08-01
• Completion: 2025-12-01
• First posted: 2023-06-28
• Last updated: 2025-12-08

Locations

1 site across 1 country: Italy