Clinical trial NCT03360500: Cryotherapy Associated With Exercise in Pain Control and Physical Function in Individuals With Knee Osteoarthritis
Official title: The Effect of Cryotherapy Associated With an Exercise Protocol in Pain Control, Physical 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
Exercise
Physiotherapy
Knee
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 120
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: PREVENTION

Brief summary: 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

Detailed 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.

Eligibility 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

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, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks
Secondary outcomes:
measure: WOMAC questionnaire (Self-administered questionnaire): Change values from the pre evaluation to the post evaluation
timeFrame: The second measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks
measure: 36-Item Short Form Survey
timeFrame: The third measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks
measure: Fast paced test in 40m test: Change values from the pre evaluation to the post evaluation
timeFrame: The fourth measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks
measure: Stair test: Change values from the pre evaluation to the post evaluation
timeFrame: The fifth measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks
measure: 30 seconds chair stand test: Change values from the pre evaluation to the post evaluation
timeFrame: The sixth measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Federal University of Sao Carlos
state: São Paulo
Study officials:
affiliation: Universidade Federal de Sao Carlos
name: Lucas O Dantas, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de Sao Carlos
name: Julya M Perea, Bachelors
role: PRINCIPAL_INVESTIGATOR
References:
citation: French HP, Abbott JH, Galvin R. Adjunctive therapies in addition to land-based exercise therapy for osteoarthritis of the hip or knee. Cochrane Database Syst Rev. 2022 Oct 17;10(10):CD011915. doi: 10.1002/14651858.CD011915.pub2.
citation: Ogura Dantas L, Serafim Jorge AE, Regina Mendes da Silva Serrao P, Aburquerque-Sendin F, de Fatima Salvini T. Cryotherapy associated with tailored land-based exercises for knee osteoarthritis: a protocol for a double-blind sham-controlled randomised trial. BMJ Open. 2020 Jun 1;10(6):e035610. doi: 10.1136/bmjopen-2019-035610.