Back to resultsCryotherapy Effectiveness in Individuals With End Stage Knee Osteoarthritis - a Case Series
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cryotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee, Cryotherapy, Physiotherapy, Physical Agent
Eligibility Criteria
Inclusion Criteria:
- 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
- Grade 4 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 40 kg/cm2
Exclusion Criteria:
- Physical therapy within 3 months prior to the research project
- Corticosteroid or Hyaluronic Acid injection in the knee (in the previous 6 months)
- Cardiorespiratory, neurological or other rheumatic dysfunctions associated with the diagnosis of knee osteoarthritis.
- Hip, knee or ankle surgery
- Any other type of chronic condition that can lead to pain.
Sites / Locations
- Federal University of São Carlos
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CRYOTHERAPY INTERVENTION
Arm Description
Patients with end stage knee osteoarthritis, both sexes, 60 years or higher
Outcomes
Primary Outcome Measures
Visual Analogue Scale (Pain scale)
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.
Secondary Outcome Measures
Western Ontario & McMaster Universities Osteoarthritis (WOMAC)
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.
40m fast paced walk test
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.
30-Second Chair to Stand Test
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.
Stair climb test
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
Short Form 36
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.
Pain catastrophizing scale
Full Information
NCT ID
NCT03582644
First Posted
June 26, 2018
Last Updated
August 1, 2019
Sponsor
Universidade Federal de Sao Carlos
1. Study Identification
Unique Protocol Identification Number
NCT03582644
Brief Title
Cryotherapy Effectiveness in Individuals With End Stage Knee Osteoarthritis - a Case Series
Official Title
Cryotherapy Effectiveness on Pain, Physical Function and Quality of Life in Individuals With End Stage Knee Osteoarthritis - a Case Series
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sao Carlos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this case series will be to provide a detailed description of a standardized short-term cryotherapy application protocol using validated functional outcome measures in individuals with end stage KOA
Detailed Description
There are no studies determining the efficacy of cryotherapy in pain, function and quality of life for patients with end stage Knee Osteoarthritis (KOA). This case series describes a standardized treatment program for end stage patients with KOA and outcomes over a 12-week period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, Knee, Cryotherapy, Physiotherapy, Physical Agent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CRYOTHERAPY INTERVENTION
Arm Type
Experimental
Arm Description
Patients with end stage knee osteoarthritis, both sexes, 60 years or higher
Intervention Type
Other
Intervention Name(s)
Cryotherapy
Other Intervention Name(s)
Cold Therapy, Ice Therapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
Visual Analogue Scale (Pain scale)
Description
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.
Time Frame
Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week)
Secondary Outcome Measure Information:
Title
Western Ontario & McMaster Universities Osteoarthritis (WOMAC)
Description
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.
Time Frame
Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week)
Title
40m fast paced walk test
Description
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.
Time Frame
Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week)
Title
30-Second Chair to Stand Test
Description
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.
Time Frame
Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week)
Title
Stair climb test
Description
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
Time Frame
Baseline assessment 1 (First week), Baseline assessment 2 (Second week), Baseline assessment 3 (Third Week), Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week)
Title
Short Form 36
Description
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.
Time Frame
Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week)
Title
Pain catastrophizing scale
Time Frame
Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Grade 4 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 40 kg/cm2
Exclusion Criteria:
Physical therapy within 3 months prior to the research project
Corticosteroid or Hyaluronic Acid injection in the knee (in the previous 6 months)
Cardiorespiratory, neurological or other rheumatic dysfunctions associated with the diagnosis of knee osteoarthritis.
Hip, knee or ankle surgery
Any other type of chronic condition that can lead to pain.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucas O Dantas
Organizational Affiliation
Universidade Federal de Sao Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of São Carlos
City
São Carlos
State/Province
São Paulo
ZIP/Postal Code
13565905
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cryotherapy Effectiveness in Individuals With End Stage Knee Osteoarthritis - a Case Series
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