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临床试验/NCT02706106
NCT02706106Unknown4 期

Assessment of a Knee Brace in Patients With Osteoarthritis

Irmandade da Santa Casa de Misericordia de Sao Paulo1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
4 期
入组人数
108
试验地点
1
主要终点
Change on pain sensation

研究概览

简要总结

It is a controlled clinical trial randomized, double-blind evaluator. Will be considered eligible patients, individuals of both sexes, aged 40 -60, to submit at least four items of knee osteoarthrosis classification criteria, according to the American College of Rheumatology, pain above four points in the visual analogue scale (VAS), diagnosed with knee osteoarthritis and who sought physical therapy treatment.

Patients will be randomized by a number sequence generated by a computer using Microsoft Excel (Microsoft Corporation, Redmond, Washington), in opaque envelopes by researcher who will not attend the study.Patients will be divided into two groups: group with knee patellar hole or group without knee patellar hole. Shortly after the selection of the knee, the patient will have his eyes blind or cover in order to keep it '' blind '' regarding the type of knee brace that it would use.

Finally evaluator 1 will cover the knee with a black cloak, making the second evaluator ''blind '' regarding the type of knee brace that will be used.

Two investigators will carry out the data collection. The first evaluator will collect information on the clinical characteristics of patients, including evaluation form, numerical pain scale, which measures the intensity of pain, test Time Up and Go (TUG) test that measures the basic mobility of movement and test walking eight meters, whose purpose is to measure the time that the individual takes to walk a distance of eight meters.

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 (Participant, Investigator)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • individuals of both sexes
  • aged 40 -60
  • at least four items of knee osteoarthrosis classification criteria, according to the American College of Rheumatology,
  • pain above four points in the visual analogue scale (VAS)
  • diagnosed with knee osteoarthritis
  • no physical therapy treatment prior

排除标准

  • neurological impairment
  • partial or total knee prosthesis
  • cardio-respiratory diseases
  • pregnant women
  • individuals who failed to perform the tests proposed

结局指标

主要结局

Change on pain sensation

时间窗: Pain will be measured before and right after or maximum five minutes after wearing the brace knee

Change on pain sensation will be compared from the baseline (before wearing the brace knee) with the pain sensation right after or maximum five minutes after wearing the brace knee. This evaluation will be performed asking the patient to identify their pain sensation by the visual analogue scale (VAS).

次要结局

  • Change on leg function(Leg function will be measured before and right after or maximum five minutes after wearing the brace knee)
  • Change on agility(Agility will be measured before and right after or maximum five minutes after wearing the brace knee)

研究者

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

Marco Aurélio Nemitalla Added

Master in Science

Irmandade da Santa Casa de Misericordia de Sao Paulo

研究点 (1)

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