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临床试验/EUCTR2012-001056-19-ES
EUCTR2012-001056-19-ES进行中(未招募)1 期

ROLE OF BIOLOGICAL THERAPY IN ROTATOR CUFF TENDINOPATHY. EFFECTIVENESS OF PLASMA RICH IN GROWTH FACTOR (PRGF-ENDORET)REGARDING TO FUNCTIONAL CAPACITY AND PAIN COMPARED WITH THE CONVENTIONAL TREATMENT USING STEROIDS

FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA DEL HOSPITAL UNIVERSITARIO PRÍNCIPE DE ASTURIAS0 个研究点目标入组 84 人开始时间: 2013年8月14日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
84

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • Patients between 40 and 70 years old
  • Male and female
  • Mild to severe symptoms according to the QuickDASH scale over 3 months of evolution.
  • Patients with tendinitis, inflammatory or calcium, tendinosis or partial tears of the rotator cuff, diagnosed by ultrasound, evaluated by an expert radiologist independent of the research team.
  • Patients refractory to the conservative treatment.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 42
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 42

排除标准

  • Patients with complete tear of the rotator cuff diagnosed by ultrasound or MRI.
  • Patients who have previously received treatment with corticoids infiltrations in the last 6 months.
  • Patients with arterial hypertension or diabetes mellitus poorly controlled.
  • Patients allergic to some of the medicines in the study or some of their excipients.
  • Patients treated with anticoagulants or antiplatelet that could not be stopped temporarily for the study.
  • Inability to understand health questionnaires and / or complete them properly.
  • Patients uncapable to give informed consent.
  • Fertile women that do not have a negative pregnancy test before being included in the study.
  • Breastfeeding women.

研究者

发起方
FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA DEL HOSPITAL UNIVERSITARIO PRÍNCIPE DE ASTURIAS

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