RESUMO
Instrumental physiotherapeutic treatment using portable devices is optimal for patients with rheumatic diseases due to the devices' greater accessibility. However, there are still issues concerning the efficacy of physical factors generated by portable equipment in osteoarthritis (OA), mostly due to the limited evidence. OBJECTIVE: To study the efficacy and safety of long-term use of the portable magnet therapy device ALMAG+ (Almag Active) in knee OA (KOA). MATERIALS AND METHODS: A double-blind, randomized, placebo-controlled, prospective, 55-week clinical trial of the medical device was conducted. The study included patients with primary and secondary (associated with immunoinflammatory rheumatic diseases) KOA stages I-III according to Kellgren-Lawrence diagnosed using generally accepted criteria (R. Altman et al., 1986). Enrollment of patients with secondary KOA was allowed given that the remission or low disease activity was achieved. During the study patients had to receive steady drug therapy. No intra-articular injections of glucocorticosteroids, hyaluronic acid, PRP, and physiotherapy procedures for knees (electrotherapy, shockwave therapy, heat therapy, hydrotherapy, peloid therapy) were allowed three months or less before the enrollment and throughout the study. According to the approved protocol, 77 patients (mean age 52.73±12.97 years) from two research centers participated in the study: 32 (41.6%) were males, and 45 (58.4%) were females. Primary KOA occurred in 41 (52%) patients, 36 (46.8%) patients had secondary KOA (associated with rheumatoid arthritis, ankylosing spondylitis, Sjögren's disease, psoriatic arthritis, systemic lupus erythematosus, or diffuse scleroderma). All patients received NSAIDs as a concomitant therapy, 24.7% received diacerein, 28.6% received disease-modifying anti-rheumatic drugs, 2.6% received methylprednisolone up to 8 mg/day, and 9% received biologic therapy. After randomization, 40 (52%) patients received placebo treatments (Group 1) and 37 (48%) received active treatments (Group 2). Both groups were comparable in the main parameters. The proportion of smokers was higher in Group 2, but the difference was not statistically significant. During the 55-week follow-up, three courses of 18 daily home magnet therapy procedures each were performed. RESULTS: In both groups, starting from week 5 of the study, an improvement of pain on movement and at rest according to VAS compared to the baseline (p<0.01 at all assessment time points) was observed, which can be explained by a pronounced placebo effect, often observed in OA. The improvement of pain at rest was more prominent in Group 2 vs. Group 1 at Week 21 (p=0.038) and Week 55 (p=0.017) of the study, probably due to the anti-inflammatory effect. The overall WOMAC index score was also lower in Group 2 vs. Group 1 at Weeks 21 and 55 (p=0.03 at both time points). The mean articular cartilage thickness, determined by ultrasound, reduced in Group 1 and remained practically unchanged in Group 2 (p=0.011). No adverse events associated with the use of the ALMAG+ (Almag Active) device, according to the attending physician, and no exacerbations of immunoinflammatory rheumatic diseases during the study period were reported. CONCLUSION: The results of a double-blind, placebo-controlled study of magnet therapy using a portable device demonstrated analgesic, anti-inflammatory, and structure-modifying effects of this type of physiotherapeutic treatment. No adverse events and exacerbations of rheumatic diseases associated with the study treatment have been reported.
Assuntos
Osteoartrite do Joelho , Adulto , Idoso , Método Duplo-Cego , Feminino , Humanos , Imãs , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/terapia , Estudos Prospectivos , Resultado do TratamentoRESUMO
Rheumatic diseases are a major medical and social problem. The mechanisms' variety of these diseases' development requires different approaches: the strategies of drug and non-drug therapy in modern rheumatology are designed to be complemented to each other. The most relevant treatment of rheumatic conditions is the method of pulsed magnetic fields because the sensitivity of biological tissues to them is the highest one. OBJECTIVE: To evaluate the efficiency and safety of the ALMAG + magnetic therapy device in the treatment of osteoarthritis of the knee joints¼. MATERIAL AND METHODS: The article presents preliminary data of a double-blind, placebo-controlled study «Evaluation of the efficacy and safety of the ALMAG + magnetic therapy device in the treatment of osteoarthritis of the knee joints¼. The study includes 70 patients (25 men, 45 women) of which 34 (48.6%) are patients with primary osteoarthritis (OA) of the knee joints (OAKS) and 36 (51.4%) are with secondary knee OA (on the background of immunoinflammatory rheumatic diseases). The patients were randomely divided into 2 groups: the main group (active devices) with 34 (48.6%) patients and the control group (placebo devices) - 36 (51.4%) patients. Patients of the main and control groups were comparable in all main parameters. During the study, the patients underwent 3 courses of treatment with the ALMAG + apparatus or with a placebo apparatus during the year. The preliminary analysis includes data on 58 patients who underwent at least 2 courses of therapy (28 patients from the main group and 30 from the control group). RESULTS: Pain at rest decreased in the main group by 4.0±2.9 mm, in the control group - by 1.07±2.21 mm (p=0.420), after the second course - by 5.13±3.4 and 1.81±2.19 mm (p=0.406), respectively. In the main group, the total WOMAC index decreased after the 1st course of physiotherapy from 24.0±14.9 to 20.25±14.31 mm (p=0.038), after the 2nd course it slightly increased - to 22.96±14.8 mm (p=0.314), in the control group the WOMAC index did not change statistically significantly: it decreased after the 1st course from 26.3±21.9 to 24.6±20.83 mm (p=0.112), after the 2nd course it increased to 27.04±21.9 mm (p=0.088). CONCLUSION: Thus, the use of the ALMAG + apparatus at home contributed to a decrease in pain at rest and a significant decrease in the WOMAC index in patients with primary and secondary OA of the knee joints. Pulsed magnetotherapy did not cause adverse events or exacerbation of immunoinflammatory diseases.
Assuntos
Osteoartrite do Joelho , Doenças Reumáticas , Feminino , Humanos , Masculino , Medição da Dor , Modalidades de Fisioterapia , Doenças Reumáticas/terapia , Resultado do TratamentoRESUMO
Rheumatic diseases are a serious medical and social problem. The variability of mechanisms for the development of this group of diseases requires different approaches: strategies of drug and non-medicament therapy in modern rheumatology are designed to complement each other. EULAR recommendations pay insufficient attention to the use of non-medical methods of joint disease treatment. According to modern research, multi-disciplinary rehabilitation strategies, including, in addition to drug therapy, educational programmes, physical training of various intensities, as well as the use of apparatus rehabilitation methods, have proven to be the most effective. Hardware physiotherapy seems to be optimal for the treatment of rheumatic patients due to its higher accessibility and lower cost in comparison with classical balneo- and peloidotherapy. With the use of magnetotherapy there is also greater safety and fewer contraindications to the procedures. The method of using pulsed magnetic fields is the most justified in the treatment of joint diseases, since the sensitivity of biological tissues to them is the highest. The clinical effectiveness of pulsed magnetotherapy has been demonstrated in several randomized placebo-controlled multi-centre studies. Against the background of carried out magnetic field therapy in patients were statistically significant reduction of pain and stiffness, improvement of joint function, which indicates the expediency of including the physical factor in the strategy of treatment of rheumatic diseases in combination with drug therapy.