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临床试验/NCT03421249
NCT03421249已完成不适用

Treatment of Knee Osteoarthrosis Using the Electromagnetic Fields: Blinded and Controlled Study

Faculdade de Ciências Médicas da Santa Casa de São Paulo0 个研究点目标入组 51 人开始时间: 2016年5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
发起方
入组人数
51
主要终点
Pain

研究概览

简要总结

This study is a randomized controlled clinical trial using a blind evaluator. Fifty-one volunteers were selected from 50 years to 70 years, obeying the following criteria: diagnosis of knee OA grade II and III through the radiographic classification of Kellgreen and Lawrence 1955, Body mass index (BMI) less than 40 kg / m², volunteers should have had knee pain for at least six months. All are from the Rehabilitation Sector of Santa Casa de Misericórdia de São Paulo (ISCMSP). The subjects were evaluated through a questionnaire developed by the authors of the study (Annex I), the Visual Analogue Scale (EVA) (Annex II), then applied to the Lower Extremity Functional Scale LEFS (Appendix III) and the Activities of daily living scale ADLs (Annex IV). In addition, the evaluation of muscular strength was through dynamometry using the Lafayete dynamometer model 01163, which was performed by a blind evaluator regarding the group that will belong to each candidate. The muscles tested were: quadriceps, ischiostibial and gluteus maximus. The randomization was through 60 brown envelopes divided into A, B, C and D, designating the randomness of the sample.

In addition to the initial evaluation, an evaluation was performed at the end of the tenth session and after 3 months of treatment.

The volunteers underwent a five-week treatment program, totaling 10 sessions, divided into four groups, group A - Intervention (INT) underwent knee and hip muscle strengthening exercises and electromagnetic field therapy with (Meditea - ARG) using the coplanar technique, group B - Exercises (EXE) carried out exercises to strengthen the hip and knee muscles in the C - Placebo group (PLA). hip and knee and electromagnetic field therapy with the Magnetron® coplanar technique, but with the device switched off and group D - Apparatus (APA) only use electromagnetic field therapy with the magnetron® coplanar technique. In the present study, there were no significant differences between groups regarding pain, function and muscle strength. However, group A obtained better results in the evaluated criteria, tending that the combination PEMF and exercises, is an indicated treatment for OA knee.

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
Single (Investigator)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of knee OA grade II and III
  • Body mass index (BMI) of less than 40 kg / m²
  • knee pain for at least six months

排除标准

  • Severe OA above grade 3
  • previous physical therapy for at least 6 months,
  • any other affection of the lower limbs (LLL) and lumbar spine,
  • obesity (BMI> 40),
  • patients with cardiovascular, metabolic, neurological, oncological or history of knee surgery.

研究组 & 干预措施

Group A - Intervention

Active Comparator

Submitted to knee and hip muscle strengthening exercises and electromagnetic field therapy with Magnetron ® (Meditea - ARG) using the coplanar technique

干预措施: Exercises (Other)

Group A - Intervention

Active Comparator

Submitted to knee and hip muscle strengthening exercises and electromagnetic field therapy with Magnetron ® (Meditea - ARG) using the coplanar technique

干预措施: Electromagnetic field therapy (Other)

Group B - exercises

Active Comparator

Performed exercises to strengthen the hip and knee muscles

干预措施: Exercises (Other)

Group C - Placebo

Placebo Comparator

Performed hip and knee strengthening exercises and electromagnetic field therapy with the coplanar Magnetron® technique, but with the device switched off

干预措施: Electromagnetic field therapy (Other)

Group D - Apparatus

Active Comparator

Only use electromagnetic field therapy with the coplanar Magnetron® technique

干预措施: Electromagnetic field therapy (Other)

结局指标

主要结局

Pain

时间窗: The visual analog pain scale was performed without onset and after 3 months after treatment

Visual Analog Pain Scale

次要结局

未报告次要终点

研究者

发起方
Faculdade de Ciências Médicas da Santa Casa de São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Diego Galace de Freitas

Principal Investigator Diego Galace de Freitas

Faculdade de Ciências Médicas da Santa Casa de São Paulo

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