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Completed

NCT Number: NCT05922618

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

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.

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Key information

Conditions

Pain, Joint Ankle Disease Arthralgia Autonomic Nervous System Diseases Complex Regional Pain Syndromes Foot Diseases Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Angela Notarnicola

Bari, 70124, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

I-One

Device

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

Primary outcomes

  1. Number of participants with allodynia

    Time frame: 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)

  2. Number of participants with allodynia

    Time frame: 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)

  3. Number of participants with allodynia

    Time frame: 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)

  4. Number of participants with hyperalgesia

    Time frame: 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)

  5. Number of participants with hyperalgesia

    Time frame: 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)

  6. Rate of edema

    Time frame: 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)

  7. Rate of edema

    Time frame: 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)

  8. Rate of edema

    Time frame: 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)

  9. Pain at movement

    Time frame: 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)

  10. Pain at movement

    Time frame: 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)

  11. Pain at movement

    Time frame: 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)

  12. Pain intensity

    Time frame: 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').

  13. Pain intensity

    Time frame: 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').

  14. Pain intensity

    Time frame: 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').

  15. Pain intensity

    Time frame: 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 outcomes

  1. Evaluate a better recovery of joint functionality

    Time frame: Change from baseline at 3 months

    •• American Foot & Ankle Score (AOFAS): scores range from 0 to 100, with healthy ankles receiving 100 points.

  2. Evaluate a better recovery of joint functionality

    Time frame: Change from baseline at 6 months

    •• American Foot & Ankle Score (AOFAS): scores range from 0 to 100, with healthy ankles receiving 100 points.

  3. Evaluate a better recovery of joint functionality

    Time frame: Change from baseline at 12 months

    •• American Foot & Ankle Score (AOFAS): scores range from 0 to 100, with healthy ankles receiving 100 points.

  4. Self-reporting measure of pain

    Time frame: Change from baseline at 3 months

    McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain)

  5. Self-reporting measure of pain

    Time frame: Change from baseline at 6 months

    McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain)

  6. Self-reporting measure of pain

    Time frame: Change from baseline at 12 months

    McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain)

  7. Number of participants taking medications

    Time frame: Change from baseline at 3 months

    • Assessment report for Non-Steroidal Anti-Inflammatory Drugs

  8. Number of participants taking medications

    Time frame: Change from baseline at 6 months

    • Assessment report for Non-Steroidal Anti-Inflammatory Drugs

  9. Number of participants taking medications

    Time frame: Change from baseline at 12 months

    • Assessment report for Non-Steroidal Anti-Inflammatory Drugs

  10. patient assessment of pain and limitations of activity

    Time frame: 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)

  11. patient assessment of pain and limitations of activity

    Time frame: 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)

  12. patient assessment of pain and limitations of activity

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Registry information

Official study title

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

Acronym: (PeCFoA)

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 28, 2023
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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