PEMFS in Patients With CRPS-I of the Foot and Ankle: a Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Diagnosis of type I CRPS according to the Budapest criteria (table 1)
• Type I CRPS involving the ankle or foot
• Onset of CRPS type I up to a maximum of 3 years after the symptomatic event
• Pain on visual analog scale (VAS) scale quantified as intensity at least ≥ 5 at recruitment
• Pharmacological treatment with first infusion cycle of neridronate
Locations
Other Locations
Italy
Angela Notarnicola
RECRUITING
Bari
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 28
Treatments
Experimental: I-ONE group
The group will undergo home biophysical treatment with I-ONE® therapy (experimental group) for 4 hours/day for 60 days. Patients will follow standard rehabilitation treatment: patients will perform active and active-assisted range of motion (ROM) recovery exercises and stretching exercises for 30 minutes per day, for 6 weeks.
No_intervention: Exercise group
The group, not subjected to biophysical therapy, will be controls. Patients will follow standard rehabilitation treatment: patients will perform active and active-assisted ROM recovery exercises and stretching exercises for 30 minutes per day, for 6 weeks.
Related Therapeutic Areas
Sponsors
Leads: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari