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临床试验/NCT03918863
NCT03918863Unknown不适用

Effects of a Neuromuscular Electrical Stimulation Protocol in Women With Patellofemoral Pain

Universidade Federal do Rio Grande do Norte4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年6月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
4
主要终点
Knee function

研究概览

简要总结

Objective this study is to analyze the effects of an intervention protocol with neuromuscular electrical stimulation in the vastus medialis obliquus and gluteus medius (GM) associated with exercises on electromyographic activity, muscle performance, self-reported functionality and pain of women with patellofemoral pain.

详细描述

This is a randomized, blinded trial in which 40 women, aged 18-30 years, will be randomized into 2 groups: Stimulation and Exercise Group (SEG) - will perform an exercise protocol associated with stimulation in the vastus medialis (VM) and gluteus medius (GM) muscles. Exercises Group (ExG) - will perform the same protocol of exercises of the previous group, however, without association with neuromuscular electrical stimulation. The intervention will occur twice a week for eight weeks. All volunteers will be submitted to the evaluation of the electromyographic activity of the VM, the GM and the vastus lateralis, the dynamometric parameters, the intensity of the pain and the functionality, in four moments: 72h hours before the beginning of the intervention; after 4 weeks of intervention; after 8 weeks of intervention; after 16 weeks from the start of the intervention (eight weeks after the end of the protocol). In this way, the investigators will investigate the applicability of the proposed trial with the use of neuromuscular electrical stimulation and identify the effects of this resource in the treatment of PFP.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Present anterior or retropatellar pain during at least two of the following functional activities: sitting for long periods, going up or down stairs, running, kneeling down, crouching or jumping;
  • A minimum pain score of three on the numerical pain scale, at the last 24 hours, with insidious and non-traumatic onset of symptoms for at least one month.

排除标准

  • History of surgery, trauma or an osteomioarticular system injury in the lower limbs in the last six months;
  • Other pathology associated with the knee joint and could not have performed physical therapy treatment in the last twelve weeks;
  • Body mass index greater than 30;
  • Pregnancy or breastfeeding;
  • Contraindications for the application of neuromuscular electrical stimulation;
  • Intolerance or non-acceptance of electric current;
  • Missing more than two intervention sessions.

研究组 & 干预措施

Neuromuscular electrical stimulation

Experimental

8-week exercise program, twice a week, with neuromuscular eletrical stimulation on vastus medialis and gluteus medius.

干预措施: Neuromuscular electrical stimulation (Other)

Exercise

Active Comparator

8-week exercise program, twice a week.

干预措施: Exercise (Other)

结局指标

主要结局

Knee function

时间窗: Change from baseline in knee function at 8 weeks.

Evaluation of knee function using the Anterior Knee Pain Scale, that is a questionnaire encompassing 13 items related to different levels of knee function, with scores ranging from zero (representing the highest possible deficit) to 100 (meaning that the subject does not present any deficit).

Knee pain

时间窗: Change from baseline in knee pain at 8 weeks.

Evaluation of pain level in the knee using the Numerical Pain Scale, graded from 0 to 10, where 0 indicates absence of pain and 10 indicates the worst pain imaginable.

次要结局

  • Root Mean Square (RMS)(Change from baseline in RMS at 8 weeks.)
  • Isokinetic performance(Change from baseline in total work at 8 weeks.)
  • Time of muscle activation (Onset)(Change from baseline in onset of the electromyographic at 8 weeks.)

研究者

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

Jamilson Simões Brasileiro

Professor

Universidade Federal do Rio Grande do Norte

研究点 (4)

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