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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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).

Eligibility

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

Study details
    Pain
    Joint
    Complex Regional Pain Syndromes
    Ankle Disease
    Foot Diseases

NCT05922618

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

27 January 2024

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