The short-term effect of cryotherapy on pain, function and quality of life of individuals in knee osteoarthitis grade 4: case series

Abstract

Introduction: Knee Osteoarthritis (KOA) is a chronic and uncomfortable condition, which often results in pain and physical dysfunction that worsen over time. Patients in the final stage of KOA present extensive osteophytes, narrowing of joint space, severe subchondral bone sclerosis, and defined bone deformity on radiographic examination. The KOA clinical guidelines emphasize the combination of non-pharmacological treatments associated with pharmacological treatments, however for patients in the final stage of KOA, there is a perception by most health professionals, though not proven, that these patients will only respond to joint replacement surgeries. Total Knee Arthroplasty (KTA) is generally considered the gold standard of treatment for the final stage of KOA, and is safe and effective. However, the procedure suffers some economic limitation and consequences depending on the age group affected. Cryotherapy is a useful resource in clinical practice, considered relatively safe, easy to administer by healthcare professionals as well as by patients, presents low cost and can be recommended alone or associated with other therapies as a non-pharmacological complementary treatment for pain control and inflammatory process. Most of the available studies have evaluated the use of the thermal agent in the initial and intermediate stages of the disease, however, conclusions regarding it is efficacy for these measures are still insufficient, mainly due to methodological limitations. Objectives: To determine the efficacy of cryotherapy in individuals in the final stage of KOA in order to reduce pain, improve function and the quality of life of these individuals. Methods: This is a double-blind, 12 weeks' case series study. Participants will be 10 patients diagnosed with grade 4 of KOA, based on the clinical and radiographic criteria of American College of Rheumatology. Patients should be 60 years or older, body mass index (BMI) less than or equal to 40kg/m² and a symptomatic KOA, with intensity of pain, based on the previous week, of four cm or more on a Visual Analogue Scale (EVA). Three initial baseline assessments will be performed before the start of the intervention with a period of one week between them. This will be followed by three consecutive weeks of intervention, three times a week as a post-intervention evaluation in the last week. Two follow-up evaluations will be performed three and six weeks after the end of intervention. All subjects will have the following variables assessed before and after intervention: pain (Visual Analogue Scale), function knee and their associated problems (knee injury and Osteoarthritis Outcome Score), physical function test (30s sit to stand test and Timed Up and Go) and a quality of life questionnaire (Short-form 36). Data Analyses: The normality of the data will be evaluated and parametric or non-parametric tests may be used. The Variance Analysis of a Factor (ANOVA) will be the parametric test chosen to analyze the main effect of time (pre, post-intervention and follow-up). The Tukey test and it is non-parametric equivalent will be used for post hoc analysis when needed. In addition, the lost data will be replaced using an intention to treat analysis with the expectation maximization method. The level of significance shall be set at 0,05 for all statistical analyzes. (AU)