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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Visual Analogue Scale (Pain scale): Change values from the pre evaluation to the post evaluation
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 36-Item Short Form Survey(The third 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(The sixth measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks)
- WOMAC questionnaire (Self-administered questionnaire): Change values from the pre evaluation to the post evaluation(The second 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(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(The fifth measurement in the pre (First day, first week) and in the post (Last day, last week) evaluation - Full protocol - 12 weeks)
Investigators
Lucas Ogura Dantas
Principal Investigator
Universidade Federal de Sao Carlos