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

NCT ID: NCT02725047

Last Updated: 2017-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-01-31

Brief Summary

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.

Detailed 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,

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TREATMENT - CRYOTHERAPY

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

Group Type: EXPERIMENTAL

Cryotherapy

Intervention Type: OTHER

Crushed ice (1kg) inside a plastic bag (24x34x0,08 cm). 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 (45x50x0,01 cm, 100% cotton)

PLACEBO - SAND

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

Group Type: PLACEBO_COMPARATOR

Placebo - Sand

Intervention Type: OTHER

Sand (1kg) inside a plastic bag (24x34x0,08 cm). The positioning of the plastic bags will cover the entire knee surface (Anterior, lateral and posterior region). After the positioning of the sand bags, they will be fixed with an elastic bandage (compression). Also, all the knee surface will be covered with a moistened operative field (45x50x0,01 cm, 100% cotton) to mimic the experimental group.

Interventions

Cryotherapy

Crushed ice (1kg) inside a plastic bag (24x34x0,08 cm). 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 (45x50x0,01 cm, 100% cotton)

Intervention Type: OTHER

Placebo - Sand

Sand (1kg) inside a plastic bag (24x34x0,08 cm). The positioning of the plastic bags will cover the entire knee surface (Anterior, lateral and posterior region). After the positioning of the sand bags, they will be fixed with an elastic bandage (compression). Also, all the knee surface will be covered with a moistened operative field (45x50x0,01 cm, 100% cotton) to mimic the experimental group.

Intervention Type: OTHER

Other Intervention Names

Ice therapy; Placebo, sham

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Sao Carlos

OTHER

Sponsor Role: lead

Responsible Party

Lucas Ogura Dantas

Lucas Ogura Dantas - Muscular Plasticity Laboratory - UFSCar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucas O Dantas, Ms. Student

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Sao Carlos

Locations

Federal University of São Carlos

São Carlos, São Paulo, Brazil

Countries

Brazil

References

Dantas LO, Breda CC, da Silva Serrao PRM, Aburquerque-Sendin F, Serafim Jorge AE, Cunha JE, Barbosa GM, Durigan JLQ, Salvini TF. Short-term cryotherapy did not substantially reduce pain and had unclear effects on physical function and quality of life in people with knee osteoarthritis: a randomised trial. J Physiother. 2019 Oct;65(4):215-221. doi: 10.1016/j.jphys.2019.08.004. Epub 2019 Sep 11.

Reference Type: DERIVED

PMID: 31521551 (View on PubMed)

Other Identifiers

CRYO-123

Identifier Type: -

Identifier Source: org_study_id