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

Primary Purpose

Pain, Joint, Complex Regional Pain Syndromes, Ankle Disease

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
I-One
Sponsored by
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Joint focused on measuring Complex Regional Pain Syndromes, foot, ankle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Angela NotarnicolaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

I-ONE group

Exercise group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of participants with allodynia
• 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 allodynia
• 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 allodynia
• 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
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)
Number of participants with hyperalgesia
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
• 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)
Rate of edema
• 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)
Rate of edema
• 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
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
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
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
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
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
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
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
•• American Foot & Ankle Score (AOFAS): scores range from 0 to 100, with healthy ankles receiving 100 points.
Evaluate a better recovery of joint functionality
•• American Foot & Ankle Score (AOFAS): scores range from 0 to 100, with healthy ankles receiving 100 points.
Evaluate a better recovery of joint functionality
•• American Foot & Ankle Score (AOFAS): scores range from 0 to 100, with healthy ankles receiving 100 points.
Self-reporting measure of pain
McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain)
Self-reporting measure of pain
McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain)
Self-reporting measure of pain
McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain)
Number of participants taking medications
• Assessment report for Non-Steroidal Anti-Inflammatory Drugs
Number of participants taking medications
• Assessment report for Non-Steroidal Anti-Inflammatory Drugs
Number of participants taking medications
• Assessment report for Non-Steroidal Anti-Inflammatory Drugs
patient assessment of pain and limitations of activity
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
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
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)

Full Information

First Posted
June 8, 2023
Last Updated
September 21, 2023
Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
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1. Study Identification

Unique Protocol Identification Number
NCT05922618
Brief Title
Pulsed Electromagnetic Fields (PEMFS) in Complex Regional Pain Syndrome Type i (CRPS-I) of the Foot (PeCFoA)
Acronym
(PeCFoA)
Official Title
PEMFS in Patients With CRPS-I of the Foot and Ankle: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
July 1, 2026 (Anticipated)
Study Completion Date
June 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Joint, Complex Regional Pain Syndromes, Ankle Disease, Foot Diseases
Keywords
Complex Regional Pain Syndromes, foot, ankle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Spontaneous, prospective, randomized study with control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I-ONE group
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
I-One
Other Intervention Name(s)
I-One, IGEA, Italy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with allodynia
Description
• Clinical assessment of allodynia (tested as pain by lightly stroking with a small brush (end of a cotton swab: dichotomic present/absent response)
Time Frame
Change from baseline at 3 months
Title
Number of participants with allodynia
Description
• Clinical assessment of allodynia (tested as pain by lightly stroking with a small brush (end of a cotton swab: dichotomic present/absent response)
Time Frame
Change from baseline at 6 months
Title
Number of participants with allodynia
Description
• Clinical assessment of allodynia (tested as pain by lightly stroking with a small brush (end of a cotton swab: dichotomic present/absent response)
Time Frame
Change from baseline at 12 months
Title
Number of participants with hyperalgesia
Description
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)
Time Frame
Change from baseline at 3 months
Title
Number of participants with hyperalgesia
Description
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)
Time Frame
Change from baseline at 12 months
Title
Rate of edema
Description
• 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)
Time Frame
Change from baseline at 3 months
Title
Rate of edema
Description
• 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)
Time Frame
Change from baseline at 6 months
Title
Rate of edema
Description
• 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)
Time Frame
Change from baseline at 12 months
Title
Pain at movement
Description
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)
Time Frame
Change from baseline at 3 months
Title
Pain at movement
Description
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)
Time Frame
Change from baseline at 6 months
Title
Pain at movement
Description
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)
Time Frame
Change from baseline at 12 months
Title
Pain intensity
Description
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').
Time Frame
Change from baseline at 3 months
Title
Pain intensity
Description
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').
Time Frame
Change from baseline at 6 months
Title
Pain intensity
Description
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').
Time Frame
Change from baseline at 12 months
Title
Pain intensity
Description
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').
Time Frame
at 12 months
Secondary Outcome Measure Information:
Title
Evaluate a better recovery of joint functionality
Description
•• American Foot & Ankle Score (AOFAS): scores range from 0 to 100, with healthy ankles receiving 100 points.
Time Frame
Change from baseline at 3 months
Title
Evaluate a better recovery of joint functionality
Description
•• American Foot & Ankle Score (AOFAS): scores range from 0 to 100, with healthy ankles receiving 100 points.
Time Frame
Change from baseline at 6 months
Title
Evaluate a better recovery of joint functionality
Description
•• American Foot & Ankle Score (AOFAS): scores range from 0 to 100, with healthy ankles receiving 100 points.
Time Frame
Change from baseline at 12 months
Title
Self-reporting measure of pain
Description
McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain)
Time Frame
Change from baseline at 3 months
Title
Self-reporting measure of pain
Description
McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain)
Time Frame
Change from baseline at 6 months
Title
Self-reporting measure of pain
Description
McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain)
Time Frame
Change from baseline at 12 months
Title
Number of participants taking medications
Description
• Assessment report for Non-Steroidal Anti-Inflammatory Drugs
Time Frame
Change from baseline at 3 months
Title
Number of participants taking medications
Description
• Assessment report for Non-Steroidal Anti-Inflammatory Drugs
Time Frame
Change from baseline at 6 months
Title
Number of participants taking medications
Description
• Assessment report for Non-Steroidal Anti-Inflammatory Drugs
Time Frame
Change from baseline at 12 months
Title
patient assessment of pain and limitations of activity
Description
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)
Time Frame
Change from baseline at 3 months
Title
patient assessment of pain and limitations of activity
Description
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)
Time Frame
Change from baseline at 6 months
Title
patient assessment of pain and limitations of activity
Description
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)
Time Frame
Change from baseline at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Angela Notarnicola
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Notarnicola
Phone
0805592938
Email
angelanotarnicola@yahoo.it

12. IPD Sharing Statement

Plan to Share IPD
No
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PubMed Identifier
17333120
Citation
Zorzi C, Dall'Oca C, Cadossi R, Setti S. Effects of pulsed electromagnetic fields on patients' recovery after arthroscopic surgery: prospective, randomized and double-blind study. Knee Surg Sports Traumatol Arthrosc. 2007 Jul;15(7):830-4. doi: 10.1007/s00167-007-0298-8. Epub 2007 Feb 28.
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Pulsed Electromagnetic Fields (PEMFS) in Complex Regional Pain Syndrome Type i (CRPS-I) of the Foot (PeCFoA)

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