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Osteoarthritis, KneeNCT02725047

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

A study testing Cryotherapy 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

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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Cryotherapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteBrazil
Study dates
Apr 2016to Jan 2017
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

Who may be able to join

  • 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

Who cannot join

  • 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 São Carlos

    São Carlos, São Paulo, 13565905

Other trials in Brazil

About this study

Official title: The Effect of Cryotherapy in Pain Control, 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 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 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,

Being tested
Cryotherapy, Placebo - Sand
Keywords
Osteoarthritis, Knee, Cryotherapy, Thermotherapy, Hypothermia, Knee, Physiotherapy
Medical subject headings
Osteoarthritis, Knee, Hyperthermia, Hypothermia

What participants receive

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

  • CryotherapyOther

    Also called Ice therapy

    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)

  • Placebo - SandOther

    Also called Placebo, sham

    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.

Study groups in NCT02725047
Study groupRoleWhat they receive
TREATMENT - CRYOTHERAPYExperimentalPatients with knee osteoarthritis, both sexes, with age between 40 and 75
Receives: Other: Cryotherapy
PLACEBO - SANDPlacebo comparatorPatients with knee osteoarthritis, both sexes, with age between 40 and 75
Receives: Other: Placebo - Sand

What is being measured

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

  1. Visual Analogue Scale (Pain scale): Change values from the pre evaluation to the post evaluation

    Visual Analog Scale for Pain:

    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 - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days

Secondary outcomes (6)
  1. Thermography (Temperature device): Change values from the pre evaluation to the post evaluation

    A thermographic camera will be used (FLIR Systems Inc. model T-420) integrated with a real resolution of 320x240 pixels, sensors for measuring temperatures ranging from -20 °C (Celsius) to + 1200 °C and with a lower sensitivity to detect temperature differences of 0,08 ºC with ± 2°C of absolute temperature measurement, according to manufacturer's specifications (FLIR Systems Inc., 2006).

    The thermographic evaluation will be conducted in a controlled environment (21 °C ± 2 °C), with fluorescent lighting and a black background for the photos. Individuals will be advised not to bathe, perform physical exercise or use metabolic stimulants and decongestants 2 hours before the test, because these procedures affect the bloodstream and consequently the thermal images of interest. They will also be instructed not to use topical products like creams, powders or sprays on the area to be evaluated.

    Measured: The second measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days

  2. Algometry (Pressure pain threshold device): Change values from the pre evaluation to the post evaluation

    To measure the pressure pain threshold, it will be used a digital algometry of mechanical pressure (ITO Co., limited company (LTD)- Physiotherapy \& Rehabilitation, OE-220 model, TOKYO, Japan) with a contact area of 1cm2. It will be performed 03 consecutive measurements (with an interval of 20s between each measurement) in 12 predetermined points chosen randomly. It will be used the average value of the 03 measurements (kg/s). At each point, the pressure pain threshold will be evaluated by applying the tip of a algometer at a speed of 1 kilogram per second, perpendicularly. The speed is controlled by the evaluator through the digital instrument display and the individual will receive a remote control with guidance to activate it at the exact moment that the pressure made by the algometry becomes painful. The interval time between each measurement will be observed to avoid temporal summation of cutaneous nociceptors.

    Measured: The third measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days

  3. 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 fourth measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days

  4. KOOS 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. KOOS is a specific questionnaire which consists of 42 items divided into 5 subscales. It is self-administrative and aims to measure the quality of life and knee function evaluating five indicators: pain, other symptoms, function in daily life, function related to sports and recreation, and quality of life related to the knee. The answers are standardized (5 options for each question) and each question has a score ranging from 0 to 4. The initial score is transformed into a scale from 0 to 100, calculated for each subscale, so that higher values indicate better functionality and lower, a worse condition. It is also validated for the Portuguese language with acceptable psychometric characteristics when compared to the original one.

    Measured: The fifth measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days

  5. TUG (Timed up and go test:Physical function questionnaire): Change values from the pre evaluation to the post evaluation

    All volunteers will conduct the test before and 1 day after the intervention. TUG is a test that evaluates the balance of the individual in the sitting position, in sitting to standing transfers, stability in ambulation and gait course changes without the use of compensatory strategies. The test consists of asking the individual to stand from a chair, walk 3 meters, turn around, go back and sit back in the chair. The timing of the test is used as a functionally independent predictor: a time below 20 seconds is considered normal and above 30 seconds is considered as a possible increased risk of falls and functional dependency. It is estimated also the ability to get up, balance, posture, the base of gait (wide or short), the start of the march (if there is hesitation or freezing), speed, step size, continuity, symmetry, balance of the trunk and limbs, involuntary movements and the ability to return.

    Measured: The seventh measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days

  6. 30 seconds chair stand test - : Physical function questionnaire: 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 eighth measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days

Timeline

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

  1. First posted31 Mar 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionOct 2016
  4. Study completionJan 2017

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02725047
Sponsor's protocol ID
CRYO-123
Status last verified
Jan 2017
First submitted
21 Mar 2016
Last updated
16 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31521551

Questions about this trial

What is this clinical trial studying?

A study testing Cryotherapy 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?

The sponsor lists 6 inclusion and 4 exclusion criteria. 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 16 Jan 2017. 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 - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days). 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 NCT02725047, which also lists 1 linked publication.

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 16 Jan 2017.

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