Complex Regional Pain Syndromes Clinical Trial
— (PeCFoA)Official title:
PEMFS in Patients With CRPS-I of the Foot and Ankle: a Randomized Controlled Trial
NCT number | NCT05922618 |
Other study ID # | PeCFoA |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2023 |
Est. completion date | June 1, 2027 |
Verified date | June 2023 |
Source | Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 28 |
Est. completion date | June 1, 2027 |
Est. primary completion date | July 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Angela Notarnicola | Bari |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari |
Italy,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Osti L, Buono AD, Maffulli N. Pulsed electromagnetic fields after rotator cuff repair: a randomized, controlled study. Orthopedics. 2015 Mar;38(3):e223-8. doi: 10.3928/01477447-20150305-61. — View Citation
Pagani S, Veronesi F, Aldini NN, Fini M. Complex Regional Pain Syndrome Type I, a Debilitating and Poorly Understood Syndrome. Possible Role for Pulsed Electromagnetic Fields: A Narrative Review. Pain Physician. 2017 Sep;20(6):E807-E822. — View Citation
Servodio Iammarrone C, Cadossi M, Sambri A, Grosso E, Corrado B, Servodio Iammarrone F. Is there a role of pulsed electromagnetic fields in management of patellofemoral pain syndrome? Randomized controlled study at one year follow-up. Bioelectromagnetics. 2016 Feb;37(2):81-8. doi: 10.1002/bem.21953. Epub 2016 Jan 12. — View Citation
Smart KM, Wand BM, O'Connell NE. Physiotherapy for pain and disability in adults with complex regional pain syndrome (CRPS) types I and II. Cochrane Database Syst Rev. 2016 Feb 24;2(2):CD010853. doi: 10.1002/14651858.CD010853.pub2. — View Citation
Ugras AA, Kural C, Kural A, Demirez F, Koldas M, Cetinus E. Which is more important after total knee arthroplasty: Local inflammatory response or systemic inflammatory response? Knee. 2011 Mar;18(2):113-6. doi: 10.1016/j.knee.2010.03.004. Epub 2010 May 14. — View Citation
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. — View Citation
Varani K, Gessi S, Merighi S, Iannotta V, Cattabriga E, Spisani S, Cadossi R, Borea PA. Effect of low frequency electromagnetic fields on A2A adenosine receptors in human neutrophils. Br J Pharmacol. 2002 May;136(1):57-66. doi: 10.1038/sj.bjp.0704695. — View Citation
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. — View Citation
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. — View Citation
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. — View 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. — View Citation
* Note: There are 29 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 3 months | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 6 months | |
Secondary | 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 | |
Secondary | Self-reporting measure of pain | McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain) | Change from baseline at 3 months | |
Secondary | Self-reporting measure of pain | McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain) | Change from baseline at 6 months | |
Secondary | Self-reporting measure of pain | McGill Pain Questionnaire: scores range from 0 (no pain) to 78 (severe pain) | Change from baseline at 12 months | |
Secondary | Number of participants taking medications | • Assessment report for Non-Steroidal Anti-Inflammatory Drugs | Change from baseline at 3 months | |
Secondary | Number of participants taking medications | • Assessment report for Non-Steroidal Anti-Inflammatory Drugs | Change from baseline at 6 months | |
Secondary | Number of participants taking medications | • Assessment report for Non-Steroidal Anti-Inflammatory Drugs | Change from baseline at 12 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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