Clinical trial NCT02725047: The Effect of Cryotherapy in Pain Control, Function and Quality of Life in Individuals With Knee Osteoarthritis
Official title: The Effect of Cryotherapy in Pain Control, Function and Quality of Life in Individuals With Knee Osteoarthritis - Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis, Knee
Cryotherapy
Thermotherapy
Hypothermia
Knee
Physiotherapy
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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,

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

Primary outcomes:
measure: Visual Analogue Scale (Pain scale): Change values from the pre evaluation to the post evaluation
timeFrame: The first measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days
Secondary outcomes:
measure: Thermography (Temperature device): Change values from the pre evaluation to the post evaluation
timeFrame: The second measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days
measure: Algometry (Pressure pain threshold device): Change values from the pre evaluation to the post evaluation
timeFrame: The third measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days
measure: WOMAC questionnaire (Self-administered questionnaire): Change values from the pre evaluation to the post evaluation
timeFrame: The fourth measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days
measure: KOOS questionnaire (Self-administered questionnaire): Change values from the pre evaluation to the post evaluation
timeFrame: The fifth measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days
measure: TUG (Timed up and go test:Physical function questionnaire): Change values from the pre evaluation to the post evaluation
timeFrame: The seventh measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days
measure: 30 seconds chair stand test - : Physical function questionnaire: Change values from the pre evaluation to the post evaluation
timeFrame: The eighth measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Federal University of São Carlos
state: São Paulo
Study officials:
affiliation: Universidade Federal de Sao Carlos
name: Lucas O Dantas, Ms. Student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.