Clinical biophysics is the branch of medicine that studies the effect of physical energy on biological systems.
Biophysical stimulation consists of the application of non-ionising physical stimuli for therapeutic purposes. It is used in the medical field to promote and accelerate the neoformation of bone tissue, to control inflammatory processes and to stimulate the anabolic activities of cartilage.
Stimulation of osteogenesis
Bone cells respond to both mechanical and electrical forces. When a load is applied to the bone, the mineralised component and the collagen matrix become electrically charged.
The electrical response of a bone to mechanical loading is known as the piezoelectric effect.
This phenomenon is responsible for the adaptation of the bone to mechanical loading and the bone remodelling that occurs in the last phase of fracture healing to optimise the mechanical competence of the bone.
Based on these observations, the first clinical experience in congenital pseudarthrosis of the tibia in paediatric patients was achieved. By inserting two metal electrodes at the ends of the pseudarthrosis, an electric current was passed through the focus of the pseudarthrosis and the patients were cured.
In order to make the stimulation of osteogenesis non-invasive by removing the need for surgical insertion of electrodes, three different methods for the administration of physical energy for therapeutic purposes have been developed:
Biophysical stimulation is a safe, non-invasive therapy that promotes bone tissue repair, accelerates fracture healing and reduces recovery time.
Pulsed Electromagnetic Fields (Biostim and Biostim SPT devices)
IGEA PEMF devices deliver a specific Pulsed Electromagnetic Field (PEMF). The signal is a pulse of 1.3 milliseconds duration with a frequency of 75 Hertz. The solenoid induces a magnetic field of peak intensity of 2.0 mT ± 0.5 mT.
The cell membrane plays a key role in recognising and transferring the physical stimulus to the various intracellular signal transduction pathways.
Stimulation with PEMF induces the release of intracellular Ca2+ from the endoplasmic reticulum. Increased cytosolic Ca2+ levels lead to activation of the calmodulin pathway, resulting in cell proliferation1 and increased release of several growth factors that contribute to bone tissue neoformation, such as TGF-ß and BMPs.2, 3 Stimulation with PEMF induces osteogenic differentiation of mesenchymal stem cells,4 promotes the production of collagen and extracellular matrix glycoproteins,3 promotes the mineralisation process5 and exerts a protective effect against osteolysis.6
Stimulation by inductive technology (PEMF) is used in the United States and Europe as a safe, non-invasive therapy for the following clinical applications:
Fresh fractures at risk of non-union7, 8
Delayed union and pseudarthrosis11, 12
Revision of prosthetic implants15
Complex regional pain syndrome
CLINICAL CASES BIOSTIM® and BIOSTIM® SPT
Exposed distal tibia fracture Clinical case study: Dr Giuseppe Caff, Dr Alessandro Pietropaolo, Dr Alessandro Famoso, Dr Giovanni Restuccia - Orthopaedics and Traumatology Unit ARNAS Garibaldi Catania
Capacitive Coupling Electric Field technique (Osteobit and Osteospine devices)
IGEA’s CCEF medical devices deliver an alternating signal at a frequency of 60 kHz that is transmitted by a pair of adhesive electrodes of a specific size. An average current density of between 15 and 30 µA/cm2 is delivered to the treatment site.
Stimulation by CCEF opens voltage-dependent calcium (Ca2+) channels.16 The increase in intracellular Ca2+ levels initiates the same cascade of events as the inductive method and, through the calmodulin metabolic pathway, leads to the release of growth factors and osteoblast proliferation.17, 18
Fresh operated and unoperated fractures at risk of non-union
The operating principle of FAST® Therapy is based on the generation, by means of a special transducer, of an ultrasound beam with an acoustic intensity of SATA (Spatial average-temporal average) of 30mW/cm².
FAST® Therapy delivers a signal consisting of 200 µs burst of 1.5 MHz sine waves, repeating at 1 kHz and delivering 30 mW/cm2 SATA intensity.
Stimulation by low-intensity pulsed ultrasound (LIPUS) acts through the stimulation of membrane mechanoreceptors that induce the formation of focal adhesion plaques on the cell surface and the subsequent activation of FAK kinase.24 Stimulation by LIPUS promotes the activation of the enzyme cyclooxygenase-2 (COX-2), which, through the synthesis of prostaglandin E2 (PGE2)25 promotes the expression of osteogenic genes, stimulating mineralisation and endochondral ossification.
Stimulation with LIPUS is a rapid, non-invasive treatment that promotes osteogenesis while reducing recovery time.
Unlike other methods that require treatment times of several hours per day (8 hours/day), the LIPUS technique requires only 20 minutes per day. The ultrasound beam is, however, rather collimated and is therefore suitable for the treatment of circumscribed areas (not exceeding 5 cm2) that must be precisely identified by means of anatomical findings. While inductive and capacitive technologies can always be used in the presence of internal fixation devices (plates, screws, nails), ultrasounds require precise identification of the direction of the ultrasound beam. If the patient has a plaque in the lateral region, the ultrasound beam needs to be directed in a mid-lateral or anteroposterior direction in order to avoid it being reflected, thus cancelling out the therapeutic benefit.
De Mattei M et al. Correlation between pulsed electromagnetic fields exposure time and cell proliferation increase in human osteosarcoma cell lines and human normal osteoblast cells in vitro. Bioelectromagnetics. 1999; 20(3):177–182.
Lohmann CH et al. Pulsed electromagnetic field stimulation of MG63 osteoblast-like cells affects differentiation and local factor production. J Orthop Res. 2000; 18(4):637–646.
Aaron RK et al. Upregulation of basal TGFß1 levels by EMF coincident with chondrogenesis - implications of skeletal repair and tissue engineering. J Orthop Res. 2002; 20:233-240.
Ongaro A et al. Pulsed electromagnetic fields stimulate osteogenic differentiation in human bone marrow and adipose tissue derived mesenchymal stem cells. Bioelectromagnetics. 2014; 35(6):426-36.
Zhou J et al. Effects of 50 Hz sinusoidal electromagnetic fields of different intensities on proliferation, differentiation and mineralization potentials of rat osteoblasts. Bone. 2011; 49(4):753–761.
Veronesi F et al. Pulsed electromagnetic fields and platelet rich plasma alone and combined for the treatment of wear-mediated periprosthetic osteolysis: An in vivo study. Acta Biomater. 2018; 77:106–115.
Faldini C et al. Electromagnetic bone growth stimulation in patients with femoral neck fractures treated with screws: Prospective randomized double-blind study. Curr Orthopaedic Pract. 2010; 21: 282-287.
Fontanesi G et al. Slow healing fractures: Can they be prevented? (Results of electrical stimulation in fibular osteotomies in rats and in diaphyseal fractures of the tibia in humans). Ital J Orthop Traumatol. 1986; 12:371-385.
Borsalino G et al. Electrical stimulation of human femoral intertrochanteric osteotomies: Doubleblind study. Clin Orthop Relat Res. 1988; 237:256-263.
Mammi GI et al. The electrical stimulation of tibial osteotomies: Double-blind study. Clin Orthop Relat Res. 1993; 288:246-253.
Traina GC et al. Effect of electromagnetic stimulation on patients suffering from non-union. A retrospective study with a control group. J Bioelectricity. 1991; 10:101-117.
Cebrian JL et al. Comparative study of the use of electromagnetic fields in patients with pseudoarthrosis of tibia treated by intramedullary nailing. Int Orthop. 2010; 34:437-440.
Cebrian JL et al. Role of Electromagnetic Stimulation in the Treatment of Osteonecrosis of the Femoral Head in Early Stages J. Biomedical Science and Engineering. 2014; 7:252-257.
Massari L et al. Biophysical Stimulation with Pulsed Electromagnetic Fields in Osteonecrosis of the Femoral Head. J. Bone Joint Surg Am. 2006; 88:56-60.
Dallari D et al. Effects of Pulsed Electromagnetic Stimulation on Patients Undergoing Hip Revision Prostheses: A Randomized Prospective Double-Blind Study. Bioelectromagnetics. 2009; 30:423-430.
Brighton CT et al. Signal transduction in electrically stimulated bone cells. J Bone Joint Surg Am. 2001; 83(A):1514–23.
Hartig M et al. Capacitively coupled electric fields accelerate proliferation of osteoblast-like primary cells and increase bone extracellular matrix formation in vitro. Eur Biophys J. 2000; 29:499–506.
Clark CC et al. Up-regulation of expression of selected genes in human bone cells with specific capacitively coupled electric fields: electrical stimulation of human osteoblasts. J Orthop Res. 2014; 32:894–903.
Impagliazzo A et al. Treatment of ununited fractures with capacitively coupled electric field. J Orthopaed Traumatol. 2006;7:16-22
Benazzo F et al. Use of capacitive coupled electric fields in stress fractures in athletes. Clin Orthop Relat Res. 1995; 310:145–149.
Rossini M et al. Capacitively Coupled Electric Field for Pain Relief in Patients with Vertebral Fractures and Chronic Pain. Clin Orthop Relat Res. 2010; 468(3):735-740.
Piazzolla A et al. Capacitive coupling electric fields in the treatment of vertebral compression fractures. J Biol Regul Homeost Agents. 2015; 29(3):637-646.
Massari L. Algorithm for employing physical forces in metabolic bone diseases. Aging Clin Exp Res 2011; 23(2):52-53.
Harrison A et al. Mode & mechanism of low intensity pulsed ultrasound (LIPUS) in fracture repair. Ultrasonics. 2016; 70:45–52.
Reher P et al. Ultrasound stimulates nitric oxide and prostaglandin E2 production by human osteoblasts. Bone. 2002; 31:236–41.
Heckman JD et al. Acceleration of tibial fracture healing by non-invasive, low-intensity pulsed ultrasound. J Bone Joint Surg Am. 1994 Jan;76(1):26-34.
Kristiansen TK et al. Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am. 1997 Jul;79(7):961-973.
Romanò CL et al. Low-intensity pulsed ultrasound for the treatment of bone delayed union or nonunion: a review. Ultrasound Med Biol. 2009; 35(4):529-536.
Schofer M et al. Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial. BMC Musculoskel Disord. 2010 Oct8;11:229.
Varani K et al. Characterization of adenosine receptors in bovine chondrocytes and fibroblast-like synoviocytes exposed to low frequency low energy pulsed electromagnetic fields. Osteoarthritis Cartilage. 2008; 16(3):292-304.
De Mattei M et al. Effects of electromagnetic fields on proteoglycan metabolism of bovine articular cartilage explants. Connective Tissue Research 2003; 44(3-4):154-9.
De Mattei M et al. Adenosine analogs and electromagnetic fields inhibit prostaglandin E(2) release in bovine synovial fibroblasts. Osteoarthritis Cartilage. 2009; 17(2):252-62.
De Mattei M et al. Effects of physical stimulation with electromagnetic field and insulin growth factor-I treatment on proteoglycan synthesis of bovine articular cartilage. Osteoarthritis Cartilage. 2004; 12(10):793-800.
Fini M et al. Effect of pulsed electromagnetic field stimulation on knee cartilage, subchondral and epyphiseal trabecular bone of aged Dunkin Hartley guinea pigs. Biomed Pharmacother. 2008; 62(10):709-15.
Veronesi F et al. In vivo effect of two different pulsed electromagnetic field frequencies on osteoarthritis. J Orthop Res. 2014; 32(5):677-85.
Benazzo F et al. Cartilage repair with osteochondral autografts in sheep: effect of biophysical stimulation with pulsed electromagnetic fields. J Orthop Res. 2008; 26(5):631-42
Gobbi A et al. Symptomatic Early Osteoarthritis of the Knee Treated With Pulsed Electromagnetic Fields: Two-Year Follow-up. Cartilage. 2014; 5:78–85.
Servodio Iammarrone C et al. Is there a role of pulsed electromagnetic fields in management of patellofemoral pain syndrome? Randomized controlled study at one year follow-up: Electromagnetic Fields in Patellofemoral Pain. 2016; 37:81-8.
Benazzo F et al. Effects of biophysical stimulation in patients undergoing arthroscopic reconstruction of anterior cruciate ligament: prospective, randomized and double blind study. Knee Surgery, Sports Traumatology, Arthroscopy. 2008; 16:595–601.
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;15:830–4
Cadossi M et al. Bone Marrow–derived Cells and Biophysical Stimulation for Talar Osteochondral Lesions: A Randomized Controlled Study. Foot Ankle Int. 2014; 35(10):981-7.
Collarile M et al. Biophysical stimulation improves clinical results of matrix-assisted autologous chondrocyte implantation in the treatment of chondral lesions of the knee. Knee Surg Sports Traumatol Arthrosc. 2018; 26(4):1223-1229.
Marcheggiani Muccioli GM et al. Conservative treatment of spontaneous osteonecrosis of the knee in the early stage: Pulsed electromagnetic fields therapy. Eur J of Radiol. 2013; 82:530-537.
Moretti B et al. I-ONE therapy in patients undergoing total knee arthroplasty: a prospective, randomized and controlled study. BMC Musculoskelet Disord. 2012; 13:88.
Adravanti P et al. Effect of pulsed electromagnetic field therapy in patients undergoing total knee arthroplasty: a randomised controlled trial. Int Orthop. 2014; 38:397–403.
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