Pain, Joint(PeCFoA)NCT05922618
Pulsed Electromagnetic Fields (PEMFS) in Complex Regional Pain Syndrome Type i (CRPS-I) of the Foot (PeCFoA)
A study testing I-One in people with Pain, Joint and Complex Regional Pain Syndromes, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Joint, Complex Regional Pain Syndromes, Ankle Disease
- What is being tested?
- I-One
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Neurological pathologies (stroke, degenerative, traumatic pathologies)
- Local neurological impairment (type II CRPS), confirmed by a conduction test or similar
- Cardiac pacemaker, treatment site malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PEMFS in Patients With CRPS-I of the Foot and Ankle: a Randomized Controlled Trial
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.
Read the 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).
- Being tested
- I-One
- Keywords
- Complex Regional Pain Syndromes, foot, ankle
- Medical subject headings
- Arthralgia, Complex Regional Pain Syndromes, Foot Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-OneDevice
Also called I-One, IGEA, Italy
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.
| Study group | Role | What they receive |
|---|---|---|
| I-ONE group | Experimental | 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. Receives: Device: I-One |
| Exercise group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change from baseline at 3 months
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)
Measured: Change from baseline at 6 months
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)
Measured: Change from baseline at 12 months
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)
Measured: Change from baseline at 3 months
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)
Measured: Change from baseline at 12 months
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)
Measured: Change from baseline at 3 months
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)
Measured: Change from baseline at 6 months
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)
Measured: Change from baseline at 12 months
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)
Measured: Change from baseline at 3 months
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)
Measured: Change from baseline at 6 months
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)
Measured: Change from baseline at 12 months
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').
Measured: Change from baseline at 3 months
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').
Measured: Change from baseline at 6 months
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').
Measured: Change from baseline at 12 months
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').
Measured: at 12 months
Secondary outcomes (12)
Evaluate a better recovery of joint functionality
•• American Foot \& Ankle Score (AOFAS): scores range from 0 to 100, with healthy ankles receiving 100 points.
Measured: Change from baseline at 3 months
Evaluate a better recovery of joint functionality
•• American Foot \& Ankle Score (AOFAS): scores range from 0 to 100, with healthy ankles receiving 100 points.
Measured: Change from baseline at 6 months
Evaluate a better recovery of joint functionality
•• American Foot \& Ankle Score (AOFAS): scores range from 0 to 100, with healthy ankles receiving 100 points.
Measured: Change from baseline at 12 months
Self-reporting measure of pain
McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain)
Measured: Change from baseline at 3 months
Self-reporting measure of pain
McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain)
Measured: Change from baseline at 6 months
Self-reporting measure of pain
McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain)
Measured: Change from baseline at 12 months
Number of participants taking medications
- Assessment report for Non-Steroidal Anti-Inflammatory Drugs
Measured: Change from baseline at 3 months
Number of participants taking medications
- Assessment report for Non-Steroidal Anti-Inflammatory Drugs
Measured: Change from baseline at 6 months
Number of participants taking medications
- Assessment report for Non-Steroidal Anti-Inflammatory Drugs
Measured: Change from baseline at 12 months
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)
Measured: Change from baseline at 3 months
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)
Measured: Change from baseline at 6 months
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)
Measured: Change from baseline at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Aug 2023
- Primary completion1 Aug 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Pain, JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Spontaneous, prospective, randomized study with control group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922618
- Sponsor's protocol ID
- PeCFoA
- Acronym
- (PeCFoA)
- Status last verified
- May 2026
- First submitted
- 8 Jun 2023
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adravanti P, Nicoletti S, Setti S, Ampollini A, de Girolamo L. Effect of pulsed electromagnetic field therapy in patients undergoing total knee arthroplasty: a randomised controlled trial. Int Orthop. 2014 Feb;38(2):397-403. doi: 10.1007/s00264-013-2216-7. Epub 2013 Dec 20.
PubMed 24352823Benazzo 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 18176941Benazzo F, Zanon G, Pederzini L, Modonesi F, Cardile C, Falez F, Ciolli L, La Cava F, Giannini S, Buda R, Setti S, Caruso G, Massari L. Effects of biophysical stimulation in patients undergoing arthroscopic reconstruction of anterior cruciate ligament: prospective, randomized and double blind study. Knee Surg Sports Traumatol Arthrosc. 2008 Jun;16(6):595-601. doi: 10.1007/s00167-008-0519-9. Epub 2008 Apr 2.
PubMed 18385980Bigoni M, Sacerdote P, Turati M, Franchi S, Gandolla M, Gaddi D, Moretti S, Munegato D, Augusti CA, Bresciani E, Omeljaniuk RJ, Locatelli V, Torsello A. Acute and late changes in intraarticular cytokine levels following anterior cruciate ligament injury. J Orthop Res. 2013 Feb;31(2):315-21. doi: 10.1002/jor.22208. Epub 2012 Aug 6.
PubMed 22886741de Girolamo L, Stanco D, Galliera E, Vigano M, Colombini A, Setti S, Vianello E, Corsi Romanelli MM, Sansone V. Low frequency pulsed electromagnetic field affects proliferation, tissue-specific gene expression, and cytokines release of human tendon cells. Cell Biochem Biophys. 2013 Jul;66(3):697-708. doi: 10.1007/s12013-013-9514-y.
PubMed 23345006de Girolamo L, Vigano M, Galliera E, Stanco D, Setti S, Marazzi MG, Thiebat G, Corsi Romanelli MM, Sansone V. In vitro functional response of human tendon cells to different dosages of low-frequency pulsed electromagnetic field. Knee Surg Sports Traumatol Arthrosc. 2015 Nov;23(11):3443-53. doi: 10.1007/s00167-014-3143-x. Epub 2014 Jun 24.
PubMed 24957914De Mattei M, Pasello M, Pellati A, Stabellini G, Massari L, Gemmati D, Caruso A. Effects of electromagnetic fields on proteoglycan metabolism of bovine articular cartilage explants. Connect Tissue Res. 2003;44(3-4):154-9.
PubMed 14504035De Mattei M, Pellati A, Pasello M, Ongaro A, Setti S, Massari L, Gemmati D, Caruso A. Effects of physical stimulation with electromagnetic field and insulin growth factor-I treatment on proteoglycan synthesis of bovine articular cartilage. Osteoarthritis Cartilage. 2004 Oct;12(10):793-800. doi: 10.1016/j.joca.2004.06.012.
PubMed 15450529De Mattei M, Varani K, Masieri FF, Pellati A, Ongaro A, Fini M, Cadossi R, Vincenzi F, Borea PA, Caruso A. Adenosine analogs and electromagnetic fields inhibit prostaglandin E2 release in bovine synovial fibroblasts. Osteoarthritis Cartilage. 2009 Feb;17(2):252-62. doi: 10.1016/j.joca.2008.06.002. Epub 2008 Jul 18.
PubMed 18640059Durmus A, Cakmak A, Disci R, Muslumanoglu L. The efficiency of electromagnetic field treatment in Complex Regional Pain Syndrome Type I. Disabil Rehabil. 2004 May 6;26(9):537-45. doi: 10.1080/09638280410001683155.
PubMed 15204461Fini M, Giavaresi G, Torricelli P, Cavani F, Setti S, Cane V, Giardino R. Pulsed electromagnetic fields reduce knee osteoarthritic lesion progression in the aged Dunkin Hartley guinea pig. J Orthop Res. 2005 Jul;23(4):899-908. doi: 10.1016/j.orthres.2005.01.008. Epub 2005 Mar 17.
PubMed 16023006Fini M, Torricelli P, Giavaresi G, Aldini NN, Cavani F, Setti S, Nicolini A, Carpi A, Giardino R. Effect of pulsed electromagnetic field stimulation on knee cartilage, subchondral and epyphiseal trabecular bone of aged Dunkin Hartley guinea pigs. Biomed Pharmacother. 2008 Dec;62(10):709-15. doi: 10.1016/j.biopha.2007.03.001. Epub 2007 Apr 3.
PubMed 17459652Gobbi A, Lad D, Petrera M, Karnatzikos G. Symptomatic Early Osteoarthritis of the Knee Treated With Pulsed Electromagnetic Fields: Two-Year Follow-up. Cartilage. 2014 Apr;5(2):78-85. doi: 10.1177/1947603513515904.
PubMed 26069687Comertoglu I, Gunes S, Elhan AH, Ustuner E, Kutlay S, Kucukdeveci AA. Effectiveness of pulsed electromagnetic field therapy in the management of complex regional pain syndrome type 1: A randomized-controlled trial. Turk J Phys Med Rehabil. 2022 Mar 1;68(1):107-116. doi: 10.5606/tftrd.2022.9074. eCollection 2022 Mar.
PubMed 35949961Marcheggiani Muccioli GM, Grassi A, Setti S, Filardo G, Zambelli L, Bonanzinga T, Rimondi E, Busacca M, Zaffagnini S. Conservative treatment of spontaneous osteonecrosis of the knee in the early stage: pulsed electromagnetic fields therapy. Eur J Radiol. 2013 Mar;82(3):530-7. doi: 10.1016/j.ejrad.2012.11.011. Epub 2012 Dec 3.
PubMed 23219192
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEMFS in Patients With CRPS-I of the Foot and Ankle: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05922618
- Acronym / sponsor ID
- (PeCFoA) / PeCFoA
- Keywords
- Complex Regional Pain Syndromes, foot, ankle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Spontaneous, prospective, randomized study with control group
| Arm | Type | Receives |
|---|---|---|
| I-ONE group | Experimental | Device: I-OneThe 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. |
| Exercise group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Neurological pathologies (stroke, degenerative, traumatic pathologies)
- Local neurological impairment (type II CRPS), confirmed by a conduction test or similar
- Cardiac pacemaker, treatment site malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-OneAlso: I-One, IGEA, ItalyI-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. | Device | I-ONE group |
Primary outcome
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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').
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').
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').
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').
12 secondary outcomes
Evaluate a better recovery of joint functionality
Time frame: Change from baseline at 3 months
Evaluate a better recovery of joint functionality
Time frame: Change from baseline at 6 months
Evaluate a better recovery of joint functionality
Time frame: Change from baseline at 12 months
Self-reporting measure of pain
Time frame: Change from baseline at 3 months
Self-reporting measure of pain
Time frame: Change from baseline at 6 months
Self-reporting measure of pain
Time frame: Change from baseline at 12 months
Number of participants taking medications
Time frame: Change from baseline at 3 months
Number of participants taking medications
Time frame: Change from baseline at 6 months
Number of participants taking medications
Time frame: Change from baseline at 12 months
patient assessment of pain and limitations of activity
Time frame: Change from baseline at 3 months
patient assessment of pain and limitations of activity
Time frame: Change from baseline at 6 months
patient assessment of pain and limitations of activity
Time frame: Change from baseline at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 24352823Adravanti P, Nicoletti S, Setti S, Ampollini A, de Girolamo L. Effect of pulsed electromagnetic field therapy in patients undergoing total knee arthroplasty: a randomised controlled trial. Int Orthop. 2014 Feb;38(2):397-403. doi: 10.1007/s00264-013-2216-7. Epub 2013 Dec 20.
- Background: PubMed 18176941Benazzo 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.
- Background: PubMed 18385980Benazzo F, Zanon G, Pederzini L, Modonesi F, Cardile C, Falez F, Ciolli L, La Cava F, Giannini S, Buda R, Setti S, Caruso G, Massari L. Effects of biophysical stimulation in patients undergoing arthroscopic reconstruction of anterior cruciate ligament: prospective, randomized and double blind study. Knee Surg Sports Traumatol Arthrosc. 2008 Jun;16(6):595-601. doi: 10.1007/s00167-008-0519-9. Epub 2008 Apr 2.
- Background: PubMed 22886741Bigoni M, Sacerdote P, Turati M, Franchi S, Gandolla M, Gaddi D, Moretti S, Munegato D, Augusti CA, Bresciani E, Omeljaniuk RJ, Locatelli V, Torsello A. Acute and late changes in intraarticular cytokine levels following anterior cruciate ligament injury. J Orthop Res. 2013 Feb;31(2):315-21. doi: 10.1002/jor.22208. Epub 2012 Aug 6.
- Background: PubMed 23345006de Girolamo L, Stanco D, Galliera E, Vigano M, Colombini A, Setti S, Vianello E, Corsi Romanelli MM, Sansone V. Low frequency pulsed electromagnetic field affects proliferation, tissue-specific gene expression, and cytokines release of human tendon cells. Cell Biochem Biophys. 2013 Jul;66(3):697-708. doi: 10.1007/s12013-013-9514-y.
- Background: PubMed 24957914de Girolamo L, Vigano M, Galliera E, Stanco D, Setti S, Marazzi MG, Thiebat G, Corsi Romanelli MM, Sansone V. In vitro functional response of human tendon cells to different dosages of low-frequency pulsed electromagnetic field. Knee Surg Sports Traumatol Arthrosc. 2015 Nov;23(11):3443-53. doi: 10.1007/s00167-014-3143-x. Epub 2014 Jun 24.
- Background: PubMed 14504035De Mattei M, Pasello M, Pellati A, Stabellini G, Massari L, Gemmati D, Caruso A. Effects of electromagnetic fields on proteoglycan metabolism of bovine articular cartilage explants. Connect Tissue Res. 2003;44(3-4):154-9.
- Background: PubMed 15450529De Mattei M, Pellati A, Pasello M, Ongaro A, Setti S, Massari L, Gemmati D, Caruso A. Effects of physical stimulation with electromagnetic field and insulin growth factor-I treatment on proteoglycan synthesis of bovine articular cartilage. Osteoarthritis Cartilage. 2004 Oct;12(10):793-800. doi: 10.1016/j.joca.2004.06.012.
- Background: PubMed 18640059De Mattei M, Varani K, Masieri FF, Pellati A, Ongaro A, Fini M, Cadossi R, Vincenzi F, Borea PA, Caruso A. Adenosine analogs and electromagnetic fields inhibit prostaglandin E2 release in bovine synovial fibroblasts. Osteoarthritis Cartilage. 2009 Feb;17(2):252-62. doi: 10.1016/j.joca.2008.06.002. Epub 2008 Jul 18.
- Background: PubMed 15204461Durmus A, Cakmak A, Disci R, Muslumanoglu L. The efficiency of electromagnetic field treatment in Complex Regional Pain Syndrome Type I. Disabil Rehabil. 2004 May 6;26(9):537-45. doi: 10.1080/09638280410001683155.
- Background: PubMed 16023006Fini M, Giavaresi G, Torricelli P, Cavani F, Setti S, Cane V, Giardino R. Pulsed electromagnetic fields reduce knee osteoarthritic lesion progression in the aged Dunkin Hartley guinea pig. J Orthop Res. 2005 Jul;23(4):899-908. doi: 10.1016/j.orthres.2005.01.008. Epub 2005 Mar 17.
- Background: PubMed 17459652Fini M, Torricelli P, Giavaresi G, Aldini NN, Cavani F, Setti S, Nicolini A, Carpi A, Giardino R. Effect of pulsed electromagnetic field stimulation on knee cartilage, subchondral and epyphiseal trabecular bone of aged Dunkin Hartley guinea pigs. Biomed Pharmacother. 2008 Dec;62(10):709-15. doi: 10.1016/j.biopha.2007.03.001. Epub 2007 Apr 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-One in people with Pain, Joint and Complex Regional Pain Syndromes, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with allodynia (time frame: Change from baseline at 3 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05922618, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.