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临床试验/NCT04042012
NCT04042012已完成不适用

Effect of the Application of Ultrasound-guided Percutaneous Needle Electrolysis on the Chronic Soleus Injury in Dancers

University of Seville2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Changes of the DFOS questionnaire

研究概览

简要总结

This study evaluates if the physiotherapy treatment based on eccentric exercise, ultrasound-guided PNE or a combination of both therapies on chronic soleous injuries may cause changes in pain, functionality, dorsal flexion of the foot, balance and muscle fatigue in dancers.

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 26 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Over 16 years.
  • at least 5 years of formal dance training.
  • at least 20 hours of training per week.
  • Pain in the back of the leg
  • diagnosis of chronic soleus injury

排除标准

  • Unsurpassed fear of needles
  • History of adverse reactions to needles
  • Immune system disorder
  • Difficulty expressing your feelings properly
  • Epilepsy and / or allergies to metals.
  • Other lower limbs pathology

结局指标

主要结局

Changes of the DFOS questionnaire

时间窗: Change from Baseline DFOS questionnaire at 3 months months

This questionnaire measures the pain and function (0= bad; 90=well)

change of pain level

时间窗: Change from Baseline VAS at 3 months months

Visual Analogue Scale (VAS: 0=no pain; 100= pain as bad as can be

Change of Lunge Test

时间窗: Change from Baseline lunge test at 3 months months

This test measures the ankle range of motion. Less than 9/10 cm, range of motion will be considered restricted

Change of the Endurance test

时间窗: Change from Baseline endurance test at 3 months months

The unilateral raised heel test. The dancer should repeatedly lift the heel from the floor to the maximum range of plantar flexion movement as many times as possible.

Change of the Releve test

时间窗: Change from Baseline releve test at 3 months months

During the unilateral balance test with open eyes, the participant will be asked to hold as much time as possible in the relay position (raised heel of the floor) on one leg

Change of the Balance test

时间窗: Change from Baseline balance test at 3 months months

The test will be conducted with closed eyes, flat feet and barefoot participants and dancers will perform a retiré position. Participants will maintain the position as long as possible.

Change of the Minimal Detectable Change (MCD)

时间窗: Change from after treatment at 3 months months

The minimal detectable change is defined as a valid change in score that is not due to chance. Minimally clinically important difference (MCID), in comparison, goes beyond valid change to assess meaningful difference in dance function

次要结局

未报告次要终点

研究者

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

Blanca de la Cruz Torres

Principal investigator

University of Seville

研究点 (2)

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