Setting the significance level at 5% and the power of the sample at 80%, a sample size of 40 patients per group was estimated to be necessary to detect a difference of at least 1 minute ± 3 seconds in the Timed Up and Go (TUG) test, which was considered to be the minimum clinically significant difference for the present trial. 0141/07, and registered with the Australian Clinical Trials Registry, no.
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The study was approved by the Research Ethics Committee of the Universidade Federal de São Paulo (UNIFESP), Brazil, no. Written informed consent was obtained from all participants. The allocation codes were sealed in opaque envelopes by a third person not involved in the study to avoid selection bias. Patients were referred from the Rheumatology Department according to the inclusion and exclusion criteria and randomly allocated into groups using a computer-generated randomization chart. The study was conducted at the Interlagos Specialty Outpatient Clinic, São Paulo, Brazil.
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It is important to study interventions with the potential to improve functional status in this patient population.
#Estim Computer Software trial
Thus, the objective of this study was to conduct a randomized clinical trial following methodological criteria, including allocation concealment, blinding of the examiner, and application of intention-to-treat analysis to assess the role of NMES in improving pain and physical function in patients with knee OA. Only one of these studies reported using allocation concealment, blinded assessment, and intention-to-treat analysis. Major flaws with regard to methodological quality were found in clinical trials testing the use of NMES in the conservative treatment of patients with knee OA. This leads to a lack of consensus regarding the effectiveness attained from including NMES in conventional rehabilitation protocols. The methods and findings of previous studies on the effectiveness of NMES in knee OA differ in the modulation of NMES parameters, choice of the outcomes used to evaluate the patients, and characteristics of the control groups. The goals of rehabilitation protocols that include NMES are to provide additional stimulus to increase muscle strength in patients with knee OA. This technique can also be used as a form of physical therapy in the treatment of patients with knee OA. Neuromuscular electrical stimulation (NMES) is defined as the application of electrical stimulation using surface electrodes placed over skeletal muscles to produce visible muscle contraction through the activation of intramuscular nerve branches. Stretching of the hamstring muscles may improve knee extension ROM in OA patients. In addition to muscle strengthening exercises, stretching exercises are commonly used to increase ROM and are often prescribed in rehabilitation protocols as part of routine warm-up to prepare the muscles and joints for other types of exercise, such as aerobic and strengthening programs. Exercises strengthen the muscles, reduce pain, improve physical function, and are therefore considered a major intervention in the conservative treatment of patients with knee OA. Because the quadriceps muscle acts as shock absorber for the knee joint, weakness in the thigh muscle reduces joint protection, resulting in overload. Through a spinal reflex, the capsular swelling inhibits muscle activation, which, combined with disuse, may cause muscle weakness and atrophy. The synovium is infiltrated with inflammatory cells and secretes excess synovial fluid, leading to capsular swelling. These symptoms lead to functional impairment, increasing the risk of morbidity and mortality. Knee OA is associated with symptoms of pain, swelling, instability, and reduced range of motion (ROM). It affects one-third of adults and tends to increase with age. Osteoarthritis (OA) is the most common form of arthritis.
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This study was registered at the Australian Clinical Trials Registry ( ACTRN012607000357459). The addition of NMES to exercise did not improve the outcomes assessed in knee OA patients. Following the interventions, a statistically significant improvement in both groups was observed in all outcomes assessed.įor the comparison between the groups, no statistically significant difference was found between the NMES + Ex and the Ex groups in NRS ( ), TUG test ( ), and aspects of WOMAC: pain ( ), function ( ), and stiffness ( ). The secondary outcomes used were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Numerical Rating Scale 0 to 10 (NRS) and the Timed Up and Go (TUG) test were the primary outcomes. Participants were randomly assigned to NMES + Ex or Ex group.
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Patients ( women = 86, men = 14 age range, 50–75 years) with knee OA. To investigate the effect of 8 weeks of NMES + Ex (neuromuscular electrical stimulation combined with exercises) on pain and functional improvement in patients with knee osteoarthritis (OA) compared to exercise (Ex) alone.