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

Not Applicable

Recruiting

• Conditions: Pain, Joint; Complex Regional Pain Syndromes; Ankle Disease; Foot Diseases
• Interventions: Device: I-One

• Registration Number: NCT05922618
• Lead Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Brief 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.

Detailed 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).

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-08
• Study First Submitted QC: 2023-06-19
• Study First Posted: 2023-06-28
• Study Start: 2023-08-01
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22
• Primary Completion: 2026-07-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I-ONE group	I-One	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with hyperalgesia	Change from baseline at 12 months	Clinical evaluation of hyperalgesia (defined as a pin prick-evoked stimulus perceived as something more painful or longer than the duration of the stimulus in the affected limb compared to the contralateral limb: dichotomic present/absent response)
Pain at movement	Change from baseline at 12 months	Pain evoked by passive movement (ankle and toe joints for foot involvement) was rated as 0=none, 1=mild, 2=moderate, 3=severe, by direct comparison with the healthy contralateral limb)
Pain intensity	at 12 months	Visual Analogue Scale (VAS): the Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Number of participants with allodynia	Change from baseline at 12 months	• Clinical assessment of allodynia (tested as pain by lightly stroking with a small brush (end of a cotton swab: dichotomic present/absent response)
Rate of edema	Change from baseline at 12 months	• Local edema (score 0=none, 1=mild, 2=moderate, 3=severe, at the level of the ankle and midfoot, by direct comparison with the healthy contralateral limb)

Secondary Outcome Measures

Name	Time	Method
Self-reporting measure of pain	Change from baseline at 12 months	McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain)
Evaluate a better recovery of joint functionality	Change from baseline at 12 months	•• American Foot \& Ankle Score (AOFAS): scores range from 0 to 100, with healthy ankles receiving 100 points.
Number of participants taking medications	Change from baseline at 12 months	• Assessment report for Non-Steroidal Anti-Inflammatory Drugs
patient assessment of pain and limitations of activity	Change from baseline at 12 months	he Roles and Maudsley score is a subjective 4-point patient assessment of pain and limitations of activity (1 = excellent result with no symptoms following treatment; 2 = significant improvement from pre-treatment; 3 = patient somewhat improved; 4 = poor, symptoms identical or worse than pre- treatment)

Trial Locations

Locations (1)

Angela Notarnicola; 🇮🇹 Bari, Italy