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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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) | 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) | 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) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate a better recovery of joint functionality | •• American Foot & Ankle Score (AOFAS): scores range from 0 to 100, with healthy ankles receiving 100 points. | Change from baseline at 3 months |
| Evaluate a better recovery of joint functionality |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angela Notarnicola | Bari | 70124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24352823 | Background | 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. | |
| 18176941 | Background | 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. |
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Spontaneous, prospective, randomized study with control group
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| 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) | 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) | 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) | 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) | 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) | 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'). | 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'). | 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'). | 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'). | at 12 months |
•• American Foot & Ankle Score (AOFAS): scores range from 0 to 100, with healthy ankles receiving 100 points.
| 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. | Change from baseline at 12 months |
| Self-reporting measure of pain | McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain) | Change from baseline at 3 months |
| Self-reporting measure of pain | McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain) | Change from baseline at 6 months |
| Self-reporting measure of pain | McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain) | Change from baseline at 12 months |
| Number of participants taking medications | • Assessment report for Non-Steroidal Anti-Inflammatory Drugs | Change from baseline at 3 months |
| Number of participants taking medications | • Assessment report for Non-Steroidal Anti-Inflammatory Drugs | Change from baseline at 6 months |
| Number of participants taking medications | • Assessment report for Non-Steroidal Anti-Inflammatory Drugs | 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) | 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) | 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) | Change from baseline at 12 months |
| 18385980 | Background | Benazzo 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. |
| 22886741 | Background | Bigoni 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. |
| 23345006 | Background | de 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. |
| 24957914 | Background | de 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. |
| 14504035 | Background | De 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. |
| 15450529 | Background | De 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. |
| 18640059 | Background | De 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. |
| 15204461 | Background | Durmus 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. |
| 16023006 | Background | Fini 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. |
| 17459652 | Background | Fini 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. |
| 26069687 | Background | Gobbi 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. |
| 35949961 | Background | Comertoglu 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. |
| 23219192 | Background | Marcheggiani 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. |
| 22672794 | Background | Moretti B, Notarnicola A, Moretti L, Setti S, De Terlizzi F, Pesce V, Patella V. I-ONE therapy in patients undergoing total knee arthroplasty: a prospective, randomized and controlled study. BMC Musculoskelet Disord. 2012 Jun 6;13:88. doi: 10.1186/1471-2474-13-88. |
| 34155875 | Background | Notarnicola A, Covelli I, Moretti L, Setti S, De Terlizzi F, Moretti B. Predictors of responsiveness to biostimulation treatments (PEMFs and/or shockwaves) in patients with complex regional pain syndrome type I of the ankle. J Biol Regul Homeost Agents. 2021 May-Jun;35(3):1087-1095. doi: 10.23812/21-122-L. No abstract available. |
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| 17698373 | Background | Varani K, De Mattei M, Vincenzi F, Gessi S, Merighi S, Pellati A, Ongaro A, Caruso A, Cadossi R, Borea PA. Characterization of adenosine receptors in bovine chondrocytes and fibroblast-like synoviocytes exposed to low frequency low energy pulsed electromagnetic fields. Osteoarthritis Cartilage. 2008 Mar;16(3):292-304. doi: 10.1016/j.joca.2007.07.004. Epub 2007 Aug 16. |
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| 26328626 | Background | Veronesi F, Cadossi M, Giavaresi G, Martini L, Setti S, Buda R, Giannini S, Fini M. Pulsed electromagnetic fields combined with a collagenous scaffold and bone marrow concentrate enhance osteochondral regeneration: an in vivo study. BMC Musculoskelet Disord. 2015 Sep 2;16:233. doi: 10.1186/s12891-015-0683-2. |
| 26480822 | Background | Veronesi F, Fini M, Giavaresi G, Ongaro A, De Mattei M, Pellati A, Setti S, Tschon M. Experimentally induced cartilage degeneration treated by pulsed electromagnetic field stimulation; an in vitro study on bovine cartilage. BMC Musculoskelet Disord. 2015 Oct 20;16:308. doi: 10.1186/s12891-015-0760-6. |
| 30671237 | Background | Kotiuk V, Burianov O, Kostrub O, Khimion L, Zasadnyuk I. The impact of mirror therapy on body schema perception in patients with complex regional pain syndrome after distal radius fractures. Br J Pain. 2019 Feb;13(1):35-42. doi: 10.1177/2049463718782544. Epub 2018 Jun 13. |
| 23741498 | Background | Vincenzi F, Targa M, Corciulo C, Gessi S, Merighi S, Setti S, Cadossi R, Goldring MB, Borea PA, Varani K. Pulsed electromagnetic fields increased the anti-inflammatory effect of A(2)A and A(3) adenosine receptors in human T/C-28a2 chondrocytes and hFOB 1.19 osteoblasts. PLoS One. 2013 May 31;8(5):e65561. doi: 10.1371/journal.pone.0065561. Print 2013. |
| 17333120 | Background | 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. |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D020918 | Complex Regional Pain Syndromes |
| D005534 | Foot Diseases |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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