Ankle Disease, Complex Regional Pain Syndromes, Foot Diseases, Pain, Joint
Conditions
Keywords
Complex Regional Pain Syndromes, foot, ankle
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).
Interventions
DEVICEI-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
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Spontaneous, prospective, randomized study with control group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with allodynia | Change from baseline at 3 months | • Clinical assessment of allodynia (tested as pain by lightly stroking with a small brush (end of a cotton swab: dichotomic present/absent response) |
| Number of participants with hyperalgesia | Change from baseline at 3 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) |
| Rate of edema | Change from baseline at 3 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) |
| Pain at movement | Change from baseline at 3 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 | Change from baseline at 3 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'). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate a better recovery of joint functionality | Change from baseline at 3 months | •• American Foot \& Ankle Score (AOFAS): scores range from 0 to 100, with healthy ankles receiving 100 points. |
| Self-reporting measure of pain | Change from baseline at 3 months | McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain) |
| Number of participants taking medications | Change from baseline at 3 months | • Assessment report for Non-Steroidal Anti-Inflammatory Drugs |
| patient assessment of pain and limitations of activity | Change from baseline at 3 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) |
Countries
Italy
Outcome results
None listed