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J Rehabil Med 2009; 41: 1090–1095 ORIGINAL REPORT EFFECT OF BIOMAGNETIC THERAPY VERSUS PHYSIOTHERAPY FOR TREATMENT OF KNEE OSTEOARTHRITIS: A RANDOMIZED CONTROLLED TRIAL* Gerald Gremion, MD, David Gaillard, BSc PhT, Pierrre-Francois Leyvraz, MD and Brigitte M. Jolles, MD From the Department of Orthopaedic Surgery (DAL), Centre Hospitalier Universitaire Vaudois, University of Lausanne, Lausanne, Switzerland Objective: To assess the effectiveness of pulsed signal therapy revealed that knee OA accounted for the highest percentage in the treatment of knee osteoarthritis (Kellgren II or III). of disability in walking, stair-climbing and housekeeping (6). Methods: A randomized, double-blind controlled clinical Population ageing will result in exponential growth in the trial. The first 95 patients sent to the clinic with knee osteo­ global burden of pain, physical disability and dependency, arthritis were selected and randomized into treatment with which will be particularly marked in Europe, North America pulsed signal therapy or conventional physiotherapy. Assess- and Australia (7), although, according to the results of the ment included recording of usual demographic data, perti- Mini-Finland Health Survey, the prevalence of knee OA among nent history, baseline medication and radiographs. Clinical women had reduced by more than 50% (8). evaluation was made at baseline, 6 weeks and 6 months after OA is an idiopathic joint disease characterized by an im- the end of treatment by the same blinded doctor. At each balance between synthesis and degradation of articular carti- follow­up time, the patient was asked to complete a visual lage and subchondral bone accompanied by capsular fibrosis, analogue pain scale and a Lequesne score. The doctor re- osteophyte formation and variable grades of inflammation of corded the degree of pain on motion and the ability to move the synovial membrane. Although cartilage degradation is the the affected knee. Results: Both treatments resulted in significant improve- net result, episodes of inflammation and pain can occur in the ments in pain and physical function. A statistical difference disease process; this process is not completely understood, but it was observed only for activities of daily living, where the is known that there is a close relationship between cartilage and physiotherapy was more efficient (p < 0.03). The cost of treat- synovial membrane activity. The breakdown of the cartilage ma- ment with pulsed signal therapy was significantly higher, trix is accompanied by bone changes, with osteophyte formation double the treatment cost of conventional physiotherapy. and thickening of the subchondral plate, where an inflammation Conclusion: Like physiotherapy, pulsed signal therapy has is often observed (9). A triggering factor causes the division improved the clinical state of treated patients but with no and activation of chondrocytes. This activation may be related significant statistical difference. Pulsed signal therapy is, to excessive force applied to the joint, or a fundamental defect however, more expensive. in the articular cartilage or underlying subchondral bone. The Key words: knee osteoarthritis, treatment outcome, physical trigger causes chondrocytes to multiply and become metaboli- therapy, randomized controlled trial, therapeutics. cally active. Chondrocytes are responsible for the regulation of articular cartilage homeostasis. Many factors are secreted and J Rehabil Med 2009; 41: 1090–1095 involved in this regulation, such as interleukin 1 (IL-1), which Correspondence address: B. Jolles, CHUV-DAL Site Hôpital stimulates the synthesis of degradative enzymes that inhibit the Orthopédique, 4, Avenue Pierre Decker, CH-1011 Lausanne, production of proteoglycans. Other cytokines, such as tumour Switzerland. E-mail: [email protected] necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6), seem Submitted February 15, 2008; accepted August 25, 2009 to work synergistically with IL-1. All of these factors are found in inflamed joints. The enzymes identified in proteoglycan and collagen degradation are the matrix metalloproteinases INTRODUCTION (MMPs). Inhibitors such as tissue inhibitor of metalloproteinase Osteoarthritis (OA) is the most prevalent and costly form of (TIMP) and plasminogen activator inhibitor-7 (PAI-7) bal- arthritis and a major cause of morbidity; many studies have ance the activation of the enzymes (10–12). Studies have also shown the significant cost of this disease (1–3). Symptomatic shown that IL-1 stimulates the production of prostaglandin E2 OA of the knee occurs in approximately 6% of adults aged 30 (PGE2). PGE2 increases the synthesis of degrading proteins years and over, with prevalence increasing with age (4, 5). A and is also an important pro-inflammatory factor contributing large community-based survey of non-institutionalized elders to vasodilatation and pain in patients with OA. Symptomatic knee OA progresses with a pattern of disease- *Trial registration: ClinicalTrial.gov NCT00415662. related impairments, such as joint pain, loss of lower limb J Rehabil Med 41 © 2009 The Authors. doi: 10.2340/16501977-0467 Journal Compilation © 2009 Foundation of Rehabilitation Information. ISSN 1650-1977 Biomagnetic therapy vs physiotherapy for knee osteoarthritis 1091 muscle strength, gait disability and reduced aerobic fitness classification (22). In order to achieve this, we conducted a possibilities (13–15). It is generally accepted that exercise double-blind randomized controlled trial comparing one group potentially reduces knee pain, improves mobility and limits of patients treated with PST and a second group of patients the decline of physical function in knee OA. But treatment treated with conventional physical therapy. We used the fol- intensity is often limited by the disease-related impairments, lowing criteria to assess the effectiveness of both treatments: together with significant comorbidity in this type of popula- outcome in terms of reduction in pain and improvement in the tion. An effective treatment “dosage” may therefore require functional index according Lequesne, tolerance in terms of pain a lengthy, but often economically prohibitive, treatment during the treatment with PST, appearance of side-effects and duration. analysis of the cost and effectiveness of the two treatments. Pulsed electromagnetic fields have been used widely to treat non-healing fractures and related problems in bone healing since approval by the Food and Drug Administration (FDA) in MATERIALS AND METHODS 1979, with a success rate averaging 70–80% (16). The original The present investigation is a double-blind randomized controlled basis for the trial of this form of therapy was the observation trial over an observation period of 6 months. The same rheumatolo- that physical stress on bone causes the appearance of tiny elec- gist obtained historical and subjective data and made all the clinical tric currents (piezoelectric potentials) that are thought to be the observations. The study was approved by the ethics committee of the Faculty of Biology and Medicine at the University of Lausanne, mechanism of transduction of the physical stresses into a signal Lausanne, Switzerland. that promotes bone formation. These piezoelectric potentials are due primarily to movement of fluid-containing electrolytes. Patients When these electrolytes move in the bone channel, which The first 95 patients sent to the clinic with knee OA at stage II or III has organic constituents with fixed charges, they generate according the radiographic criteria published by Kellgren & Lawrence “streaming potentials” (17). Studies of electrical phenomena (22) were selected. Informed consent for entry into the clinical trial in cartilage have shown a mechanical-electrical transduction was obtained and patients were then randomly assigned to PST or conventional physiotherapy. Inclusion criteria required patients to mechanism similar to that described in bone, appearing when be at least 35 years old, with local symptoms such as pain and stiff- cartilage is mechanically compressed, causing movement of ness over a period of at least one year, and with persistent symptoms fluid and electrolytes, leaving unneutralized negative charges despite non-steroidal anti-inflammatory drugs (NSAIDs). Patients in the proteoglycans and collagen in the cartilage matrix (18). were instructed not to change their basic regimen (drugs) during the These streaming potentials apparently serve a purpose in car- observation period. The use of medications was checked by history at each evaluation point. Informed consent for entry into the double- tilage similar to that in bone, transforming mechanical stress blind trial was mandatory. Exclusion criteria were applied for patients into an electrical phenomenon capable of stimulating chondro- who had an operative treatment (surgery or arthroscopy) in the last 6 cyte synthesis of matrix components (19). These streaming months, who had an intra-articular injection in the last 4 months, who potentials can also lower the threshold of nociceptive afferents had a basic rheumatic disease, who had a homolateral coxarthrosis innervating the joint capsule (induced by arthritis) and explain or who had a malignant disorder. Other exclusion criteria included a body mass index (BMI) greater than 33% of average, pregnancy the pain reduction observed in many studies. or inability to understand the visual analogue scale (VAS). Indeed, Increasingly in the last 6 years throughout Europe, more

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