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

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05922618

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Joint Complex Regional Pain Syndromes Ankle Disease Foot Diseases	Device: PEMFS	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Spontaneous, prospective, randomized study with control groupSpontaneous, prospective, randomized study with control group

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2026

Anticipated Study Completion Date :

Jun 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: I-ONE group 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: PEMFS 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. Other Names: I-One, IGEA, Italy
No Intervention: Exercise group 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.

Arm

Intervention/Treatment

Experimental: I-ONE group

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: PEMFS

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.

Other Names:

I-One, IGEA, Italy

No Intervention: Exercise group

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.

Outcome Measures

Primary Outcome Measures

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)
Allodynia [Change from baseline at 6 months]
• Clinical assessment of allodynia (tested as pain by lightly stroking with a small brush (end of a cotton swab: dichotomic present/absent response)
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)
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)
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)
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)
Edema [Change from baseline at 6 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)
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)
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 at movement [Change from baseline at 6 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 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 [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').
Pain intensity [Change from baseline at 6 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').
Pain intensity [Change from baseline 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').
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').

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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