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

Study Overview
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Brief Summary
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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
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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).

Official Title
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PEMFS in Patients With CRPS-I of the Foot and Ankle: a Randomized Controlled Trial

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

Intervention / Treatment
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* Device: I-One


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Spontaneous, prospective, randomized study with control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I-ONE group<br>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. | Device: I-One<br>* 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.<br>* Other names: I-One, IGEA, Italy;|
| No Intervention: Exercise group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with allodynia | • Clinical assessment of allodynia (tested as pain by lightly stroking with a small brush (end of a cotton swab: dichotomic present/absent response) | Change from baseline at 3 months | 
| Number of participants with allodynia | • Clinical assessment of allodynia (tested as pain by lightly stroking with a small brush (end of a cotton swab: dichotomic present/absent response) | Change from baseline at 6 months | 
| Number of participants with allodynia | • Clinical assessment of allodynia (tested as pain by lightly stroking with a small brush (end of a cotton swab: dichotomic present/absent response) | Change from baseline at 12 months | 
| Number of participants with hyperalgesia | 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) | Change from baseline at 3 months | 
| Number of participants with hyperalgesia | 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) | Change from baseline at 12 months | 
| Rate of edema | • 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) | Change from baseline at 3 months | 
| Rate of edema | • 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) | Change from baseline at 6 months | 
| Rate of edema | • 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) | Change from baseline at 12 months | 
| Pain at movement | 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) | Change from baseline at 3 months | 
| Pain at movement | 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) | Change from baseline at 6 months | 
| Pain at movement | 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) | Change from baseline at 12 months | 
| Pain intensity | 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'). | Change from baseline at 3 months | 
| Pain intensity | 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'). | Change from baseline at 6 months | 
| Pain intensity | 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'). | Change from baseline at 12 months | 
| Pain intensity | 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'). | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate a better recovery of joint functionality | •• American Foot & Ankle Score (AOFAS): scores range from 0 to 100, with healthy ankles receiving 100 points. | Change from baseline at 3 months | 
| Evaluate a better recovery of joint functionality | •• American Foot & Ankle Score (AOFAS): scores range from 0 to 100, with healthy ankles receiving 100 points. | Change from baseline at 6 months | 
| Evaluate a better recovery of joint functionality | •• American Foot & Ankle Score (AOFAS): scores range from 0 to 100, with healthy ankles receiving 100 points. | Change from baseline at 12 months | 
| Self-reporting measure of pain | McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain) | Change from baseline at 3 months | 
| Self-reporting measure of pain | McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain) | Change from baseline at 6 months | 
| Self-reporting measure of pain | McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain) | Change from baseline at 12 months | 
| Number of participants taking medications | • Assessment report for Non-Steroidal Anti-Inflammatory Drugs | Change from baseline at 3 months | 
| Number of participants taking medications | • Assessment report for Non-Steroidal Anti-Inflammatory Drugs | Change from baseline at 6 months | 
| Number of participants taking medications | • Assessment report for Non-Steroidal Anti-Inflammatory Drugs | Change from baseline at 12 months | 
| patient assessment of pain and limitations of activity | 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) | Change from baseline at 3 months | 
| patient assessment of pain and limitations of activity | 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) | Change from baseline at 6 months | 
| patient assessment of pain and limitations of activity | 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) | Change from baseline at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complex Regional Pain Syndromes, foot, ankle