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

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ClinicalTrials.gov Identifier: NCT05922618
Recruitment Status : Recruiting
First Posted : June 28, 2023
Last Update Posted : September 22, 2023
Sponsor:
Information provided by (Responsible Party):
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Study Description
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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: I-One Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Spontaneous, 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
Actual Study Start Date : August 1, 2023
Estimated Primary Completion Date : July 1, 2026
Estimated Study Completion Date : June 1, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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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: I-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.

Other Name: 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
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05922618


Locations
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Italy
Angela Notarnicola Recruiting
Bari, Italy, 70124
Contact: Angela Notarnicola    0805592938    angelanotarnicola@yahoo.it   
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
More Information
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Publications:

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Responsible Party: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
ClinicalTrials.gov Identifier: NCT05922618    
Other Study ID Numbers: PeCFoA
First Posted: June 28, 2023    Key Record Dates
Last Update Posted: September 22, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari:
Complex Regional Pain Syndromes
foot
ankle
Additional relevant MeSH terms:
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Foot Diseases
Arthralgia
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Syndrome
Disease
Pathologic Processes
Autonomic Nervous System Diseases
 Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Skin Diseases
Joint Diseases
Pain
Neurologic Manifestations