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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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.
Angela Notarnicola
Bari, Italy
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Change from baseline at 3 months
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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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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').
Time frame: 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').
Time frame: 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').
Time frame: 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').
Time frame: at 12 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline at 12 months
Self-reporting measure of pain
McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain)
Time frame: Change from baseline at 3 months
Self-reporting measure of pain
McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain)
Time frame: Change from baseline at 6 months
Self-reporting measure of pain
McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain)
Time frame: Change from baseline at 12 months
Number of participants taking medications
• Assessment report for Non-Steroidal Anti-Inflammatory Drugs
Time frame: Change from baseline at 3 months
Number of participants taking medications
• Assessment report for Non-Steroidal Anti-Inflammatory Drugs
Time frame: Change from baseline at 6 months
Number of participants taking medications
• Assessment report for Non-Steroidal Anti-Inflammatory Drugs
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Change from baseline at 12 months