Determination of the Effectiveness of Certain Physical Methods in the Treatment of Knee Osteoarthritis

Summary

Participation Requirements

Description

The research will be conducted in the Department of Orthopedic surgery of the Clinical Hospital Center Zagreb. The research will be prospective, randomized, single blinded. Randomization of patients will be performed before physical therapy using web site www.randomization.com, and the results of th...

The research will be conducted in the Department of Orthopedic surgery of the Clinical Hospital Center Zagreb. The research will be prospective, randomized, single blinded. Randomization of patients will be performed before physical therapy using web site www.randomization.com, and the results of the randomization will be known to the physician who will not be directly involved in the treatment or examination of patients. All patients will sign informed consent before the study begins. Research has been approved by the Ethics Committee of Clinical Hospital Center Zagreb and Ethics committee of the School of Medicine, University of Zagreb. Inclusion criteria are: patients age 55 years and older who have knee OA according to the American College of Rheumatology criteria (ACR) and knee OA according to Kellgren and Lawrence Radiology Classification Grade 1 and 2, and who report knee pain for at least 3 months. Exclusion criteria are: patients who had surgery on that knee, patients with a pacemaker, and metallic foreign body in the area of muscle stimulation, patients with thrombophlebitis and deep vein thrombosis, patients with skin infection, malignancy, bleeding disorders, patients with neurological disease, patients with inflammatory rheumatological disease, with congenital and acquired knee deformities, with contractures of the hips and ankles, with grade 3 and 4 osteoarthritis according to Kellgren and Lawrence classification, patients who received intraarticular knee injection in the last 3 months and patients with post-traumatic knee osteoarthritis and osteonecrosis. The investigators will record: age, sex, height, weight, body mass index, leg length and use of orthopedics aids. Clinical examination will be performed on the first day, day 21, after 90 and after 180 days. At each examination patients will complete following questionnaires: Visually Analog Scale for pain (VAS), Western Ontario Universities Osteoarthritis Index (WOMAC), 36 Item Short Form Health Survey (SF 36) and International Classification of Functioning, Disability and Health (ICF) osteoarthritis core set. Quadriceps muscle strength will be measured with a Biofeedback therapy device (EMG Biofeedback, Myomed 632, United Kingdom, 2017) . Patients will be randomisen in three groups. Patients in the first group will be treated with individual kinesitherapy. Patients in the second group will be treated with individual kinesitherapy and biofeedback therapy for strengthening of the quadriceps muscle using EMG Biofeedback device, Myomed 632, United Kingdom, 2017. Patients in the third group will be treated with individual kinesitherapy together with electrical stimulation of the quadriceps muscle using electrostimulation device (BTL- 4000 Smart, United Kingdom, 2017). The required sample size was calculated based on pain values data reported in the study by Choi et al. Pain was measured using VAS scale, and sample size was calculated using G Power software package (v3.1.9.4). With the parameter of statistical significance level (alpha) of 0.05 and a test power (1 - beta) of 0.90, based on the data from the Choi et al work, the required final sample size is a total of 93 subjects and 31 subjects for each of the three groups. The investigators expect to find that kinesitherapy and biofeedback therapy are more efficient compared to kinesitherapy alone or and kinesitherapy and electrical stimulation in reducing pain, improving knee function and strengthening of the quadriceps muscle.

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