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
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
28 participants
Aug 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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
Exclusion Criteria3
- Neurological pathologies (stroke, degenerative, traumatic pathologies)
- Local neurological impairment (type II CRPS), confirmed by a conduction test or similar
- Cardiac pacemaker, treatment site malignancy
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Interventions
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.
Locations(1)
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NCT05922618