The Effect of Cryotherapy in Pain Control, Function and Quality of Life in Individuals With Knee Osteoarthritis - Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale (Pain scale): Change values from the pre evaluation to the post evaluation
研究概览
简要总结
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.
详细描述
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,
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Visual Analogue Scale (Pain scale): Change values from the pre evaluation to the post evaluation
时间窗: The first measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days
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.
次要结局
- 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)
- 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)
- 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)
- 30 seconds chair stand test - : Physical function questionnaire: Change values from the pre evaluation to the post evaluation(The eighth measurement in the pre (First day - 1) and in the post (Last day - 6) evaluation - Full protocol - 6 days)
研究者
Lucas Ogura Dantas
Lucas Ogura Dantas - Muscular Plasticity Laboratory - UFSCar
Universidade Federal de Sao Carlos