Evaluation of the Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis: A Prospective Double Blind, Randomized, Sham-Controlled Clinical Study

Inclusion Criteria: * Diagnoses of knee osteoarthritis:( American College of Rheumatology (ACR) criteria (see below) - possibilities:ACR1: Fulfilled at least one of the classification criteria of the American College of Rheumatology ACR2: KOA verified with the American College of Rheumatology criteria using a history and physical examination, i.e. knee pain and at least three of the following: 50-85 years old, ≤ 30 minutes of morning stiffness, crepitus on active range of motion, bony tenderness, bony enlargement, and no palpable warmth of synovia Radiographic evidence of knee osteoarthritis between 2-3 in Kellgren and Lawrence classification * KOA grade 2-3 * Knee pain on movement 40 to 90 mm Visual Analog Scale * Knee pain for the last ≥ 3 months * Functional reduction in the last three months * Agrees not to use NSAIDs throughout the experiment * Agrees not to use any other treatment (except rescue drugs) for KOA during participation in this study. Exclusion Criteria: * Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, etc) have been ruled out by physical examinations * Knee surgery for KOA * Intra-articular steroid injection and/or oral steroid treatment within the last six months * Rheumatoid arthritis; * Symptomatic OA in other joints (i.e. hip, hand) * Use of analgesics on the day of evaluation * Use of NSAIDs 2 weeks before the beginning of the treatment * Active malignancy * Uncontrolled diabetes mellitus * Neurological conditions: sciatica, neuropathy, multiple sclerosis * Other chronic pain conditions: Fibromyalgia, back pain, hip pain * Enrolled in any other clinical trial within the last 6 weeks or enrollment in another clinical trial during participation in this trial.