Incorporation of Photobiomodulation Therapy in an Exercise Program With Blood Flow Restriction for Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Functional pain
研究概览
简要总结
Knee osteoarthritis (OA) is one of the most common musculoskeletal disorders in the world. The aim of this project is to evaluate the additional effect of photobiomodulation therapy on the quadriceps muscle and knee joint in a blood flow restriction exercise program for individuals with knee OA. To this end, volunteers will be selected at random, aged between 40 and 65 years with pain in one knee, at least in the last 6 months, diagnosed with unilateral knee OA based on the criteria established by the American College of Rheumatology and radiographic confirmation for grades 2 or 3 of the Kellgren-Lawrence Classification, will be randomized into the following groups: (Exercises with blood flow restriction, n = 20), (Exercises with blood flow restriction + photobiomodulation, n = 20) and Exercises with blood flow restriction + placebo photobiomodulation (n = 20). 12 consecutive weeks of treatment will be carried out, with the volunteers being evaluated before and after, using the following instruments: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), sit and stand test, Timed up and Go (TUG), numerical scale pain assessment (END), pain-to-pressure threshold (LDP), skin temperature: quadriceps musculature, knee joint and maximum voluntary isometric contraction (MVIC) of the muscles: quadriceps, middle gluteus. For data analysis, normality test will be used to verify the data distribution and statistical test consistent with the appropriate comparisons within and between groups, thus, two factors are considered in the comparisons, time and group. A significance level of 5% will be adopted.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •knee pain to at least six months and minimum of 4 points in pain scale
- •diagnosis of unilateral knee OA based on criteria established by the American College of Rheumatology and radiographic confirmation for grades 2 or 3 of the Kellgren-Lawrence Classification.
排除标准
- •Score on the numerical visual analog of knee pain less than 1 or greater than 8;
- •knee trauma;
- •Cognitive impairment;
- •Psychological disorder;
- •Neurological disorder (sensory or motor);
- •Diabetes any acute adverse health condition;
- •Signs of hip OA;
- •Sings cardiopulmonary disease that could prevent exercise and use of a walking assist device.
- •Have undergone any form of treatment involving: physiotherapy, intra-articular corticosteroids, anti-inflammatories or chondroprotectors in the last year.
- •If the size of the circumference of the thigh and knee does not allow the proper positioning of the photobiomodulation mesh.
结局指标
主要结局
Functional pain
时间窗: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
Stiffness
时间窗: Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
Physical functional
时间窗: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
次要结局
- Intensity of pain(Change from Baseline in The Numerical rating pain scale at 12 weeks)
- Functional capacity for sitting and standing(Change from Baseline in The Functional capacity for sitting and standing at 12 weeks)
- Level of pressure pain(Change from Baseline in ThePressure Pain Threshold at 12 weeks)
- Muscle skin temperature(Change from Baseline in the muscle skin temperature at 12 weeks)
- Maximum voluntary isometric contraction(Change from Baseline in the Maximum voluntary isometric contraction at 12 weeks)
研究者
Cid André Fidelis de Paula Gomes
Clinical Professor.
University of Nove de Julho