NCT03360500

Cryotherapy Associated With Exercise in Pain Control and Physical Function in Individuals With Knee Osteoarthritis

The Effect of Cryotherapy Associated With an Exercise Protocol in Pain Control, Physical Function and Quality of Life in Individuals With Knee Osteoarthritis - Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Universidade Federal de Sao Carlos · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to verify the effect of cryotherapy associated with an exercise protocol in pain control, function and quality of life in individuals with knee osteoarthritis

Detailed description

The purpose of this study is to verify the effect of cryotherapy associated with an exercise protocol in pain control, function and quality of life in individuals with knee osteoarthritis. This is a randomized controlled clinical trial, double-blinded. Will participate in the study 120 patients with knee osteoarthritis, diagnosed with clinical and radiographic criteria of the American College of Rheumatology, of both sexes, aged between 40 and 75 years. The total number of subjects will be divided randomly into three groups of 40 subjects each. During eight weeks, three times per week, each group will receive one type of intervention: Exercise protocol for knee osteoarthritis + cryotherapy, Exercise protocol for knee osteoarthritis + placebo or Exercise protocol for knee osteoarthritis only. A medical certificate will be requested for all participants, showing the capability of practicing physical activities. Every individual will have the following variables evaluated one day pre- and one day post-intervention process: Pain index (VAS), physical function questionnaires (WOMAC) and quality of life (sf-36 questionnaire). Three physical function tests will also be carried out: the 30s sitting and standing chair, Stair test and fast paced test in 40m. Moreover, participants will perform VAS in every physical function test. A follow-up period will be performed.

Conditions

• Osteoarthritis,Knee

Interventions

Type	Name	Description
OTHER	EXERCISE PROTOCOL + CRYOTHERAPY	Protocol: The therapeutic exercise protocol was designed according to the recommendations and guidelines of evidence-based practices and specific randomized clinical trials of physical exercise intervention for Knee osteoarthritis. The suggested parameters for an adequate prescription of physical exercises include the type, application method, intensity, duration, minimum number of sessions and frequency of exercises. Cryotherapy: Crushed ice inside two plastic bags. The positioning of the plastic bags will cover the entire knee surface (Anterior, lateral and posterior region). After the positioning of the ice bags, they will be fixed with an elastic bandage (compression). To protect the skin against frost bites, all the knee surface will be covered with a moistened operative field.
OTHER	EXERCISE PROTOCOL	Protocol: The therapeutic exercise protocol was designed according to the recommendations and guidelines of evidence-based practices and specific randomized clinical trials of physical exercise intervention for Knee osteoarthritis. The suggested parameters for an adequate prescription of physical exercises include the type, application method, intensity, duration, minimum number of sessions and frequency of exercises.
OTHER	EXERCISE PROTOCOL + PLACEBO	Protocol: The therapeutic exercise protocol was designed according to the recommendations and guidelines of evidence-based practices and specific randomized clinical trials of physical exercise intervention for Knee osteoarthritis. The suggested parameters for an adequate prescription of physical exercises include the type, application method, intensity, duration, minimum number of sessions and frequency of exercises. Placebo: Sand inside two plastic bags. The positioning of the plastic bags will cover the entire knee surface (Anterior, lateral and posterior region). After the positioning of the sandbags, they will be fixed with an elastic bandage (compression). All the knee surface will be covered with a moistened operative field.

Timeline

• Start date: 2018-03-26
• Primary completion: 2023-08-24
• Completion: 2023-08-24
• First posted: 2017-12-04
• Last updated: 2024-09-27

Locations

1 site across 1 country: Brazil