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

Universidade Federal de Sao Carlos

Status: Completed

Conditions: Osteoarthritis,Knee

Treatments: Other: EXERCISE PROTOCOL + CRYOTHERAPY; Other: EXERCISE PROTOCOL; Other: EXERCISE PROTOCOL + PLACEBO

Study type: Interventional

Funder types: Other

Identifiers

NCT03360500

CRYO-1234

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main 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

Main 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

EXERCISE PROTOCOL + CRYOTHERAPY

Experimental group

Description:

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

Treatment:

Other: EXERCISE PROTOCOL + CRYOTHERAPY

EXERCISE PROTOCOL

Experimental group

Description:

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

Treatment:

Other: EXERCISE PROTOCOL

EXERCISE PROTOCOL + PLACEBO

Placebo Comparator group

Description:

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

Treatment:

Other: EXERCISE PROTOCOL + PLACEBO