Clinical trial NCT05922618: Pulsed Electromagnetic Fields (PEMFS) in Complex Regional Pain Syndrome Type i (CRPS-I) of the Foot (PeCFoA)
Official title: PEMFS in Patients With CRPS-I of the Foot and Ankle: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Joint
Complex Regional Pain Syndromes
Ankle Disease
Foot Diseases
Keywords: Complex Regional Pain Syndromes
foot
ankle
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Spontaneous, prospective, randomized study with control group
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Number of participants with allodynia
timeFrame: Change from baseline at 3 months
measure: Number of participants with allodynia
timeFrame: Change from baseline at 6 months
measure: Number of participants with allodynia
timeFrame: Change from baseline at 12 months
measure: Number of participants with hyperalgesia
timeFrame: Change from baseline at 3 months
measure: Number of participants with hyperalgesia
timeFrame: Change from baseline at 12 months
measure: Rate of edema
timeFrame: Change from baseline at 3 months
measure: Rate of edema
timeFrame: Change from baseline at 6 months
measure: Rate of edema
timeFrame: Change from baseline at 12 months
measure: Pain at movement
timeFrame: Change from baseline at 3 months
measure: Pain at movement
timeFrame: Change from baseline at 6 months
measure: Pain at movement
timeFrame: Change from baseline at 12 months
measure: Pain intensity
timeFrame: Change from baseline at 3 months
measure: Pain intensity
timeFrame: Change from baseline at 6 months
measure: Pain intensity
timeFrame: Change from baseline at 12 months
measure: Pain intensity
timeFrame: at 12 months
Secondary outcomes:
measure: Evaluate a better recovery of joint functionality
timeFrame: Change from baseline at 3 months
measure: Evaluate a better recovery of joint functionality
timeFrame: Change from baseline at 6 months
measure: Evaluate a better recovery of joint functionality
timeFrame: Change from baseline at 12 months
measure: Self-reporting measure of pain
timeFrame: Change from baseline at 3 months
measure: Self-reporting measure of pain
timeFrame: Change from baseline at 6 months
measure: Self-reporting measure of pain
timeFrame: Change from baseline at 12 months
measure: Number of participants taking medications
timeFrame: Change from baseline at 3 months
measure: Number of participants taking medications
timeFrame: Change from baseline at 6 months
measure: Number of participants taking medications
timeFrame: Change from baseline at 12 months
measure: patient assessment of pain and limitations of activity
timeFrame: Change from baseline at 3 months
measure: patient assessment of pain and limitations of activity
timeFrame: Change from baseline at 6 months
measure: patient assessment of pain and limitations of activity
timeFrame: Change from baseline at 12 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Angela Notarnicola
Study officials:
References:
citation: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.