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History of Changes for Study: NCT05922618
Pulsed Electromagnetic Fields (PEMFS) in Complex Regional Pain Syndrome Type i (CRPS-I) of the Foot (PeCFoA) ((PeCFoA))
Latest version (submitted September 21, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 19, 2023 None (earliest Version on record)
2 July 7, 2023 Outcome Measures, Arms and Interventions and Study Status
3 July 10, 2023 Outcome Measures, Study Description and Study Status
4 July 21, 2023 Study Status
5 September 21, 2023 Recruitment Status, Study Status, Contacts/Locations and Oversight
Comparison Format:
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Study NCT05922618
Submitted Date:  June 19, 2023 (v1)
Open or close this module Study Identification
Unique Protocol ID: PeCFoA
Brief Title: Pulsed Electromagnetic Fields (PEMFS) in Complex Regional Pain Syndrome Type i (CRPS-I) of the Foot (PeCFoA) ((PeCFoA))
Official Title: PEMFS in Patients With CRPS-I of the Foot and Ankle: a Randomized Controlled Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2023
Overall Status: Not yet recruiting
Study Start: July 1, 2023
Primary Completion: July 1, 2026 [Anticipated]
Study Completion: June 1, 2027 [Anticipated]
First Submitted: June 8, 2023
First Submitted that
Met QC Criteria:		 June 19, 2023
First Posted: June 28, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:		 June 19, 2023
Last Update Posted: June 28, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.
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).
Open or close this module Conditions
Conditions: Pain, Joint
Complex Regional Pain Syndromes
Ankle Disease
Foot Diseases
Keywords: Complex Regional Pain Syndromes
foot
ankle
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Spontaneous, prospective, randomized study with control group
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 28 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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. 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. 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. 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. 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. 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. 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. 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. Taking medications
[ Time Frame: Change from baseline at 3 months ]

• Assessment report for Non-Steroidal Anti-Inflammatory Drugs
8. Taking medications
[ Time Frame: Change from baseline at 6 months ]

• Assessment report for Non-Steroidal Anti-Inflammatory Drugs
9. 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)
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Locations: Italy
Angela Notarnicola
Bari, Italy, 70124
Contact:Contact: Angela Notarnicola 0805592938 angelanotarnicola@yahoo.it
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
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Benazzo F, Cadossi M, Cavani F, Fini M, Giavaresi G, Setti S, Cadossi R, Giardino R. Cartilage repair with osteochondral autografts in sheep: effect of biophysical stimulation with pulsed electromagnetic fields. J Orthop Res. 2008 May;26(5):631-42. doi: 10.1002/jor.20530. PubMed 18176941
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