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

NCT05922618 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-08-01
Completion
2025-12-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05922618 on ClinicalTrials.gov