Cryotherapy Associated With Exercise in Pain Control and Physical Function in Individuals With Knee Osteoarthritis

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

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

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis,Knee
• Intervention / Treatment: Other: EXERCISE PROTOCOL + CRYOTHERAPY; Other: EXERCISE PROTOCOL; Other: EXERCISE PROTOCOL + PLACEBO

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julya M Perea, Bachelors; Phone Number: +5516997011617; Email: julyapegatin@gmail.com

Study Locations

• Brazil
  • São Paulo
    • São Carlos, São Paulo, Brazil, 251
      • Recruiting
      • Federal University of São Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXERCISE PROTOCOL + CRYOTHERAPY; Patients with knee osteoarthritis, both sexes, with age between 40 and 75	Other: EXERCISE PROTOCOL + CRYOTHERAPY; Protocol: The therapeutic exercise protocol was designed according to the recommendations and guidelines of evidence-based practices and specific randomized clinical trials of physical exercise intervention for Knee osteoarthritis. The suggested parameters for an adequate prescription of physical exercises include the type, application method, intensity, duration, minimum number of sessions and frequency of exercises. Cryotherapy: Crushed ice inside two plastic bags. 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.
Experimental: EXERCISE PROTOCOL; Patients with knee osteoarthritis, both sexes, with age between 40 and 75	Other: EXERCISE PROTOCOL; Protocol: The therapeutic exercise protocol was designed according to the recommendations and guidelines of evidence-based practices and specific randomized clinical trials of physical exercise intervention for Knee osteoarthritis. The suggested parameters for an adequate prescription of physical exercises include the type, application method, intensity, duration, minimum number of sessions and frequency of exercises.
Placebo Comparator: EXERCISE PROTOCOL + PLACEBO; Patients with knee osteoarthritis, both sexes, with age between 40 and 75	Other: EXERCISE PROTOCOL + PLACEBO; Protocol: The therapeutic exercise protocol was designed according to the recommendations and guidelines of evidence-based practices and specific randomized clinical trials of physical exercise intervention for Knee osteoarthritis. The suggested parameters for an adequate prescription of physical exercises include the type, application method, intensity, duration, minimum number of sessions and frequency of exercises. Placebo: Sand inside two plastic bags. The positioning of the plastic bags will cover the entire knee surface (Anterior, lateral and posterior region). After the positioning of the sandbags, they will be fixed with an elastic bandage (compression). All the knee surface will be covered with a moistened operative field.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (Pain scale): Change values from the pre evaluation to the post evaluation	A visual analog scale (VAS) will be applied to measure the pain before and 1 day after the intervention. VAS is a well recognized tool to measure the intensity of pain that visually represents the intensity of pain that the individual believes to present. The scale will be positioned in front of the individual and will have a range of 0 to 10 cm, with 0 being the complete absence of pain and 10, the maximum intensity of pain reported by the individual.	The first measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WOMAC questionnaire (Self-administered questionnaire): Change values from the pre evaluation to the post evaluation	All volunteers will answer to the questionnaire before and 1 day after the intervention. WOMAC is a self-report questionnaire designed to assess the problems experienced by people with OA of the lower limb. The score for the items is expressed through a Likert scale, where the rating is calculated as: none = 0, low = 25 = 50 moderate, severe = 75 and very severe = 100. The maximum score on each section is expressed as a percentage, with higher scores indicating greater pain, stiffness and physical dysfunction. Each point corresponds to a particular dimension (pain, stiffness and physical function). This questionnaire has been translated and validated for the Portuguese language from Brazil.	The second measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks
36-Item Short Form Survey	SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.	The third measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks
Fast paced test in 40m test: Change values from the pre evaluation to the post evaluation	Fast paced walking test that is timed by a distance of 4X10 meters, totaling 40 meters. It is used as a direct measure to correlate the ability to walk fast, short distances. Administered at a distance of 10 meters (demarcated by tapes), a cone is placed 2 meters before the start and 2 meters after the end of each marking. The participant is instructed to walk the 10 meters (from the start marking), turn around in the cone and walk another 10 meters, successively until completing the distance of 40 meters. Time is considered only between the tracks (start and end). The final score is calculated based on the speed of the participant performs the procedure and compared with normative values of healthy adults.	The fourth measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks
Stair test: Change values from the pre evaluation to the post evaluation	Test where the participant should go up and down a stair in the shortest possible time. The participant will be positioned in front of the stair, and at the therapeut sign must climb the indicated steps (12 steps), and go down, being able to use the handrail as a security instrument. The height of each stair step will be 20 cm, with a handrail, in an illuminated environment, free of traffic and external distractions. A pre-test is performed to identify the need for safety measures. The final score is calculated based on the time the participant performs the procedure and compared with the normative values available for the test	The fifth measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks
30 seconds chair stand test: Change values from the pre evaluation to the post evaluation	All volunteers performed the test before and 1 day after the intervention. The 30 seconds chair stand test is administered using an armless chair, with seat height of about 43cm from the ground. The chair has a rubber for not slipping under its support and is placed against a wall to avoid oscillations. The participant sits in the middle of the chair with the back straight, feet apart, aligned with the shoulder width apart and flat on the floor at an angle slightly behind the knee line. Moreover, to help maintain balance, one foot may be slightly placed ahead of the other and arms crossed against the chest. The test consists of the greatest number of times from a sitting position to a standing over a period of 30 seconds. Thus, it is possible to evaluate a wide range of skill levels with scores ranging from 0, for those who cannot complete a single repetition and values greater than 20 reps for the well prepared individuals.	The sixth measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks

Collaborators and Investigators

• Sponsor: Universidade Federal de Sao Carlos
• Investigators: Principal Investigator: Lucas O Dantas, PhD Student, Universidade Federal de Sao Carlos; Principal Investigator: Julya M Perea, Bachelors, Universidade Federal de Sao Carlos

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2018
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; Knee; Physiotherapy; Cryotherapy; Osteoarthritis, Knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CRYO-1234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No