The Effect of Cryotherapy in Pain Control, Function and Quality of Life in Individuals With Knee Osteoarthritis

Universidade Federal de Sao Carlos

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Other: Placebo - Sand; Other: Cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02725047

CRYO-123

Details and patient eligibility

About

The purpose of this study is to verify the effect of cryotherapy 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 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 60 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 two groups of 30 subjects each. During four consecutive days, for a period of 20 min, each group will receive one type of intervention around the knee with osteoarthritis: the cryotherapy group will receive an application of ice bags with compression and the placebo group will receive an application of sand bags with compression, the weight and volume of the sand bags will be similar to that used in cryotherapy. Every individual will have the following variables evaluated one day pre- and one day post-intervention: pressure pain threshold (Algometry), pain index (VAS), physical function questionnaires (WOMAC, KOOS) and physical activity (IPAQ). Two physical function tests will also be carried out: the 30s sitting and standing chair and the Timed Up and Go (TUG). Thermographic images will also be obtained for further temperature analysis of the knee with osteoarthritis. Moreover, after a period of 3 months, participants will perform a follow-up in which will be measured the VAS, WOMAC and KOOS questionnaires. Also, some Yes/No questions about the continued use of the therapy will be asked,

Enrollment: 60 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with knee osteoarthritis based on clinical and radiographic criteria of American College of Rheumatology
• Osteoarthritis signals in at least one of the compartments of the knee joint (tibiofemoral and / or the patellofemoral joint)
• Do not perform regular physical activity - less than three times a week regularly
• 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)
• Body Mass Index less or equal to 45 kg/cm2

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: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

TREATMENT - CRYOTHERAPY

Experimental group

Description:

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

Treatment:

Other: Cryotherapy

PLACEBO - SAND

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo - Sand