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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-26

Study Completion Date

2023-08-24

Brief Summary

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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

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Detailed Description

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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

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Osteoarthritis,Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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EXERCISE PROTOCOL + CRYOTHERAPY

Patients with knee osteoarthritis, both sexes, with age between 40 and 75

Group Type EXPERIMENTAL

EXERCISE PROTOCOL + CRYOTHERAPY

Intervention Type OTHER

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.

EXERCISE PROTOCOL

Patients with knee osteoarthritis, both sexes, with age between 40 and 75

Group Type EXPERIMENTAL

EXERCISE PROTOCOL

Intervention Type OTHER

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.

EXERCISE PROTOCOL + PLACEBO

Patients with knee osteoarthritis, both sexes, with age between 40 and 75

Group Type PLACEBO_COMPARATOR

EXERCISE PROTOCOL + PLACEBO

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with knee osteoarthritis based on clinical and radiographic criteria of American College of Rheumatology
* Grade 2 or 3 according to the criteria of Kellgren \& Lawrence knee osteoarthritis radiographic examination scale.
* Minimum score of 4 cm in Visual Analogue Scale (total 10 cm)
* Medical prescription, showing that the participant is capable of performing physical activities

Exclusion Criteria

* Physical therapy within 3 months prior to the research project
* Corticosteroid injection in the knee (in the previous 6 months)
* Medical condition (cardiorespiratory, neurological and / or musculoskeletal)
* Previous ankle, knee or hip surgery

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No