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

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Status: Enrolling

Conditions: Complex Regional Pain Syndromes; Foot Diseases; Ankle Disease; Pain, Joint

Treatments: Device: I-One

Study type: Interventional

Funder types: Other

Identifiers

NCT05922618

PeCFoA

Details and patient eligibility

About

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.

Full 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).

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• Neurological pathologies (stroke, degenerative, traumatic pathologies)
• Local neurological impairment (type II CRPS), confirmed by a conduction test or similar
• Cardiac pacemaker, treatment site malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

28 participants in 2 patient groups

I-ONE group

Experimental group

Description:

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.

Treatment:

Device: I-One

Exercise group

No Intervention group

Description:

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.