Cryotherapy associated with strengthening exercises in pain, physical function and quality of life of individuals with knee Osteoarthritis: randomized and controlled clinical trial by Sham

• Grant number: 22/03302-7
• Support Opportunities: Scholarships in Brazil - Doctorate (Direct)
• Effective date (Start): July 01, 2022
• Effective date (End): June 30, 2026
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Tania de Fatima Salvini
• Grantee: Julya Pegatin Moreno Perea
• Host Institution: Centro de Ciências Biológicas e da Saúde (CCBS). Universidade Federal de São Carlos (UFSCAR). São Carlos , SP, Brazil
• Associated scholarship(s): 23/02854-9 - The integration of cognitive behavioral therapy for insomnia in best-practice care for patients with knee osteoarthritis and insomnia: randomized controlled trial, BE.EP.DD

Abstract

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. To analyze the residual effects of the interventions, a 3-month and 6-month follow-up will be performed. Participants will be individuals with KOA, divided into 3 groups (40 per group): (1) KOA+Exercise+Crio: they will perform a protocol of supervised strengthening exercises (3x/week, 45 min, 8 weeks) and, after finishing 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+Exercicio: control group, will receive only the intervention with strengthening exercises and will remain at rest for 20 min after the end of the exercises. 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. (AU)