NCT02725047

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 16, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

March 21, 2016

Last Update Submit

January 13, 2017

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, KneeCryotherapyThermotherapyHypothermiaKneePhysiotherapy

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (6)

  • Thermography (Temperature device): Change values from the pre evaluation to the post evaluation

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

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

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

  • WOMAC questionnaire (Self-administered questionnaire): Change values from the pre evaluation to the post evaluation

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

  • KOOS questionnaire (Self-administered questionnaire): Change values from the pre evaluation to the post evaluation

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

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

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

  • +1 more secondary outcomes

Study Arms (2)

TREATMENT - CRYOTHERAPY

EXPERIMENTAL

Patients with knee osteoarthritis, both sexes, with age between 40 and 75

Other: Cryotherapy

PLACEBO - SAND

PLACEBO COMPARATOR

Patients with knee osteoarthritis, both sexes, with age between 40 and 75

Other: Placebo - Sand

Interventions

CryotherapyOTHER

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)

Also known as: Ice therapy
TREATMENT - CRYOTHERAPY
Placebo - SandOTHER

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.

Also known as: Placebo, sham
PLACEBO - SAND

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Carlos

São Carlos, São Paulo, 13565905, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 31521551DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeHyperthermiaHypothermia

Interventions

CryotherapyIcesalicylhydroxamic acid

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsWaterHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsEnvironmentEcological and Environmental PhenomenaBiological PhenomenaWeatherMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Lucas O Dantas, Ms. Student

    Universidade Federal de Sao Carlos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lucas Ogura Dantas - Muscular Plasticity Laboratory - UFSCar

Study Record Dates

First Submitted

March 21, 2016

First Posted

March 31, 2016

Study Start

April 1, 2016

Primary Completion

October 1, 2016

Study Completion

January 1, 2017

Last Updated

January 16, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)