The purpose of this study is to determine whether Extracorporeal Focused Shock Wave Therapy
reduces knee pain and enhance function in patients with primary knee osteoarthritis.
Device: Extracorporeal Shock Waves
Device: Sham Extracorporeal Shock Waves
Other: Physical activities
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Full eligibility criteria for NCT02904785
Ages eligible for Study
45 Years to 80 Years
Genders eligible for Study
Accepts Healthy Volunteers
Clinical and radiologic diagnosis of primary knee osteoarthritis (Kellgren & Lawrence I, II or III);
Capability to understand the Informed Consent Form;
Chronic pain for at least 3 months prior to inclusion, measured by VAS. (VAS 4 or above);
Absence of skin injures, infections or tumor in the target knee;
Availability to comply with the visits.
History of spinal cord stenosis or clinical symptoms of lumbar radiculopathy;
History or onset neurological diseases;
Generalized pain or fibromyalgia;
Inability to walk;
History of knee surgery in the target knee;
Secondary causes of osteoarthritis;
Use of statins and quinolones in the previous year;
Uncontrolled and ongoing psychiatric diseases;
Invasive knee treatments with hyaluronic acid infusion, corticosteroids and anaesthetics, in the target knee, up to 6 months previous to study inclusion.
All locations for NCT02904785
Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP
Sao Paulo, Brazil, 04116-030
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View full eligibility
Tris trial is registered with FDA with number: NCT02904785. The sponsor of the trial is University of Sao Paulo General Hospital and it is looking for 30 volunteers for the current phase.
Official trial title: The Efficacy of Extracorporeal Focused Shock Wave Therapy for Patients With Primary Knee Osteoarthritis
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