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临床试验/NCT02636764
NCT02636764已完成不适用

Influence of Using Physical Therapy Resources for Knee Osteoarthritis

University of Nove de Julho1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
pain

研究概览

简要总结

Osteoarthritis is a chronic, multifactorial characterization, which changes in bone alignment, cartilage and structures that provide joint stability appear to be strongly correlated with the origin of this disease.This project will aim to verify the effectiveness of interferential current, short wave and low level laser therapy on an exercise program for mobility and pain in knee osteoarthritis. Blind randomized, placebo controlled. Five groups: exercise group, exercise group + Ultrasound therapy, exercise group + interferential current, exercise group + short-wave diathermy, exercise group + Low level laser therapy. Before and after the trial protocol by the following instruments: Western Ontario and McMaster Universities osteoarthritis index (WOMAC), numerical scale of pain assessment (END), Visual Analogue Scale Fatigue (VAS-F), issue F2.2 Instrument assessment of quality of life of the World Health Organization (WHOQOL-100) test sitting and standing + numerical rating pain scale, algometry. This project hypothesizes that the inclusion of photothermal and electrical agents in an exercise program will provide an improvement in pain, mobility and knee function in individuals diagnosed with knee osteoarthritis.

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 80 Years(Adult, Older Adult)
性别
All
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
  • •Diagnosed with osteoarthritis in unilateral knee according to the criteria established by the American College of Rheumatology and confirmed by radiographic examination for identification Kellgren-Lawrence grade 2 or 3 (Kellgren & Lawrence, 1957).

排除标准

  • •Any type of physical therapy
  • •therapy with intra-articular corticosteroids or therapeutic chondroprotective drugs last year, before the start of the study.
  • •history of trauma on his knees, cognitive disorder or psychological disorder,
  • •neurological (sensory or motor)
  • •diabetes,
  • •or any state of adverse acute health osteoarthritis signs of hip
  • •cardiopulmonary disease that prevents the conducting exercises
  • •require auxiliary device for performing gait.
  • •Yet who undertake physical activity in the last two months. Physical activity is defined as strength training and / or more than 20 minutes of aerobic activity twice a week.

研究组 & 干预措施

exercise group + Ultrasound therapy

Placebo Comparator

Apart from intervening in the exercise group, an ultrasound device is used .

干预措施: exercise (Other)

exercise group + Ultrasound therapy

Placebo Comparator

Apart from intervening in the exercise group, an ultrasound device is used .

干预措施: Ultrasound therapy (Device)

exercise group

Active Comparator

An exercise protocol drawn up with the objective will be held to strengthen the musculature: flexor and extensor of the knee; extension, abduction, hip side rotator, using the weight and the elastic band.

干预措施: exercise (Other)

exercise group + interferential current

Experimental

Besides the intervention of the exercise group after the exercises will be applied to interferential current through the device. Will be positioned 4 electrodes (8x5 cm), two upper and two lower (forming a square) around the center of the knee.

干预措施: exercise (Other)

exercise group + interferential current

Experimental

Besides the intervention of the exercise group after the exercises will be applied to interferential current through the device. Will be positioned 4 electrodes (8x5 cm), two upper and two lower (forming a square) around the center of the knee.

干预措施: interferential current (Device)

exercise group + short-wave diathermy

Experimental

Besides the intervention of the exercise group after the exercises will be applied diathermies short wave in continuous mode. For that will be used apparatus, 27.12 megahertz, by means of vulcanized rubber electrodes (12x17 cm) with gentle warming for 30 minutes.

干预措施: exercise (Other)

exercise group + short-wave diathermy

Experimental

Besides the intervention of the exercise group after the exercises will be applied diathermies short wave in continuous mode. For that will be used apparatus, 27.12 megahertz, by means of vulcanized rubber electrodes (12x17 cm) with gentle warming for 30 minutes.

干预措施: short-wave diathermy (Device)

exercise group + Low level laser therapy

Experimental

Apart from intervening in the exercise group, will be applied to Low level laser therapy, through the laser unit, Class 3b, gallium-aluminum-arsenide, continuous mode, wavelength: 830 nanometer, power: 30 watts.

干预措施: exercise (Other)

exercise group + Low level laser therapy

Experimental

Apart from intervening in the exercise group, will be applied to Low level laser therapy, through the laser unit, Class 3b, gallium-aluminum-arsenide, continuous mode, wavelength: 830 nanometer, power: 30 watts.

干预措施: Low level laser therapy (Device)

结局指标

主要结局

pain

时间窗: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks

The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.

stiffness

时间窗: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 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 8 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 8 weeks)
  • Self-perceived fatigue(Change from Baseline in The question of F2.2 instrument for assessing quality of life World Health Organization (WHOQOL-100) at 8 weeks)
  • Functional capacity for sitting and standing(Change from Baseline in The Functional capacity for sitting and standing at 8 weeks)
  • level of pressure pain(Change from Baseline in ThePressure Pain Threshold at 8 weeks)
  • Self-perceived fatigue(Change from Baseline in the self-perceived fatigue at 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cid André Fidelis de Paula Gomes

Phd

University of Nove de Julho

研究点 (1)

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