Osteoarthritis,KneeNCT03360500

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

A study testing EXERCISE PROTOCOL + CRYOTHERAPY and EXERCISE PROTOCOL in people with Osteoarthritis,Knee, run by Universidade Federal de Sao Carlos at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Osteoarthritis,Knee
What is being tested?: EXERCISE PROTOCOL + CRYOTHERAPY and EXERCISE PROTOCOL
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteBrazil
Study dates: 26 Mar 2018to 24 Aug 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Federal University of Sao Carlos
São Carlos, São Paulo, 251

Other trials in Brazil

About this study

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

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

Read the 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.

Conditions: Osteoarthritis,Knee
Being tested: EXERCISE PROTOCOL + CRYOTHERAPY, EXERCISE PROTOCOL, EXERCISE PROTOCOL + PLACEBO
Keywords: Osteoarthritis, Knee, Cryotherapy, Exercise, Physiotherapy, Knee
Medical subject headings: Osteoarthritis, Knee, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EXERCISE PROTOCOL + CRYOTHERAPYOther
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.
EXERCISE PROTOCOLOther
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.
EXERCISE PROTOCOL + PLACEBOOther
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.

Study groups in NCT03360500
Study group	Role	What they receive
EXERCISE PROTOCOL + CRYOTHERAPY	Experimental	Patients with knee osteoarthritis, both sexes, with age between 40 and 75 Receives: Other: EXERCISE PROTOCOL + CRYOTHERAPY
EXERCISE PROTOCOL	Experimental	Patients with knee osteoarthritis, both sexes, with age between 40 and 75 Receives: Other: EXERCISE PROTOCOL
EXERCISE PROTOCOL + PLACEBO	Placebo comparator	Patients with knee osteoarthritis, both sexes, with age between 40 and 75 Receives: Other: EXERCISE PROTOCOL + PLACEBO

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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 (5)

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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: The sixth measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 201824 Aug 2023

First posted4 Dec 2017
Study start26 Mar 2018
Primary completion24 Aug 2023
Study completion24 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Osteoarthritis,KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03360500
Sponsor's protocol ID: CRYO-1234
Status last verified: Sep 2024
First submitted: 28 Nov 2017
Last updated: 27 Sep 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 36250418
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.
PubMed 32482668

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
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Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
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Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
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All Osteoarthritis,Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03360500
Acronym / sponsor ID: CRYO-1234
Conditions: Osteoarthritis,Knee
Keywords: Osteoarthritis, Knee, Cryotherapy, Exercise, Physiotherapy, Knee
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Universidade Federal de Sao CarlosUniversity, hospital or other
Study start: 26 Mar 2018 (actual)
Primary completion: 24 Aug 2023 (actual)
Study completion: 24 Aug 2023 (actual)
First posted: 4 Dec 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
EXERCISE PROTOCOL + CRYOTHERAPY	Experimental	Other: EXERCISE PROTOCOL + CRYOTHERAPYPatients with knee osteoarthritis, both sexes, with age between 40 and 75
EXERCISE PROTOCOL	Experimental	Other: EXERCISE PROTOCOLPatients with knee osteoarthritis, both sexes, with age between 40 and 75
EXERCISE PROTOCOL + PLACEBO	Placebo comparator	Other: EXERCISE PROTOCOL + PLACEBOPatients with knee osteoarthritis, both sexes, with age between 40 and 75

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EXERCISE PROTOCOL + CRYOTHERAPYProtocol: 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.	Other	EXERCISE PROTOCOL + CRYOTHERAPY
EXERCISE PROTOCOLProtocol: 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.	Other	EXERCISE PROTOCOL
EXERCISE PROTOCOL + PLACEBOProtocol: 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.	Other	EXERCISE PROTOCOL + PLACEBO

Primary outcome

Visual Analogue Scale (Pain scale): Change values from the pre evaluation to the post evaluation
Time frame: The first measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks
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.

5 secondary outcomes

WOMAC questionnaire (Self-administered questionnaire): Change values from the pre evaluation to the post evaluation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: The sixth measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
Derived from this study: PubMed 36250418French 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.
Derived from this study: PubMed 32482668Ogura 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.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis,Knee

Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
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Recruiting
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lucas O Dantas, PhD Student principal investigator

Universidade Federal de Sao Carlos

Julya M Perea, Bachelors principal investigator

Universidade Federal de Sao Carlos

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EXERCISE PROTOCOL + CRYOTHERAPY and EXERCISE PROTOCOL in people with Osteoarthritis,Knee, run by Universidade Federal de Sao Carlos at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (Pain scale): Change values from the pre evaluation to the post evaluation (time frame: The first measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03360500, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.