ntroduction: Muscle strengthening exercises are strongly recommended in the treatment of individuals with knee osteoarthritis (KOA), as they reduce pain and improve physical function. Other non-pharmacological therapeutic resources are widely used in physiotherapy, associated with physical exercises in the treatment of KOA, but there is a lack of scientific evidence about their benefits. Cryotherapy has been used in joints with rheumatic diseases due to its effect on reducing pain, inflammation and swelling. However, studies with greater methodological rigor are needed to assess its effects in individuals with KOA. Objective: to carry out a controlled clinical trial to analyze the possible effects of cryotherapy, associated with a protocol of muscle strengthening exercises, on pain, function and quality of life of individuals with KOA. Our hypothesis is that cryotherapy will provide an additional benefit to the exercises in these individuals, with an increase in the improvement of pain, function and quality of life. Methods and analyses: Randomized, sham-controlled clinical trial with hidden allocation and intent-to-treat analysis. Assessments: at the beginning and immediately after the intervention period. For analysis of residual effects of interventions, a 3-month and 6-month follow-up will be performed. The participants will be individuals with KOA, divided into 3 groups (n=40 per group): (1) KOA+Exercise+Crio: they will perform a protocol of supervised strengthening exercises (3x/week, 45 min, 8 weeks) and, after at the end of each exercise session, they will receive cryotherapy (ice pack, 20 min) around the affected knee; (2) KOA+Exercise+Sham: they will receive the same exercise protocol as the previous group and, after the end of the exercises, they will receive a sham procedure (sandbag, 20 min) around the affected knee; (3) KOA+Exercise: will only receive the intervention with strengthening exercises and later, it will remain at rest for 20 min. The primary outcome will be pain intensity (Visual Analog Scale - VAS). Secondary outcomes: results from the Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) questionnaire, Short Form Health Survey 36 (SF-36); 30-second functional sit-and-stand tests, step-up and down-step test, and 40-meter brisk walk test. The project was approved by the Institutional Ethics Committee of the Federal University of São Carlos, São Paulo, Brazil (CAAE: 65966617.9.0000.5504) and registered as a clinical trial (NCT03360500). Data normality will be evaluated and parametric or non-parametric tests may be used. Intention-to-treat analysis will be performed for all randomized participants.
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