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

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

Sponsors

Lead Sponsor: Universidade Federal de Sao Carlos

Source Universidade Federal de Sao Carlos
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,

Overall Status Completed
Start Date April 2016
Completion Date January 2017
Primary Completion Date October 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Visual Analogue Scale (Pain scale): Change values from the pre evaluation to the post evaluation The first measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days
Secondary Outcome
Measure Time Frame
Thermography (Temperature device): Change values from the pre evaluation to the post evaluation The second measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days
Algometry (Pressure pain threshold device): Change values from the pre evaluation to the post evaluation The third measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days
WOMAC questionnaire (Self-administered questionnaire): Change values from the pre evaluation to the post evaluation The fourth measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days
KOOS questionnaire (Self-administered questionnaire): Change values from the pre evaluation to the post evaluation The fifth measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days
TUG (Timed up and go test:Physical function questionnaire): Change values from the pre evaluation to the post evaluation The seventh measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days
30 seconds chair stand test - : Physical function questionnaire: Change values from the pre evaluation to the post evaluation The eighth measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days
Enrollment 60
Condition
Intervention

Intervention Type: Other

Intervention Name: Cryotherapy

Description: 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)

Arm Group Label: TREATMENT - CRYOTHERAPY

Other Name: Ice therapy

Intervention Type: Other

Intervention Name: Placebo - Sand

Description: 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.

Arm Group Label: PLACEBO - SAND

Other Name: 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

Gender: All

Minimum Age: 40 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Lucas O Dantas, Ms. Student Principal Investigator Universidade Federal de Sao Carlos
Location
Facility: Federal University of São Carlos
Location Countries

Brazil

Verification Date

January 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Universidade Federal de Sao Carlos

Investigator Full Name: Lucas Ogura Dantas

Investigator Title: Lucas Ogura Dantas - Muscular Plasticity Laboratory - UFSCar

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: TREATMENT - CRYOTHERAPY

Type: Experimental

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

Label: PLACEBO - SAND

Type: Placebo Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov