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临床试验/EUCTR2010-020513-87-IT
EUCTR2010-020513-87-IT
进行中(未招募)
不适用

A randomized, placebo-controlled, double-blind study on the intensity and duration of efficacy of sodium hyaluronate therapy (500-730 KDa) (HYALGAN) in the conservative treatment of Achilles tendinopathy. - ND

FIDIA0 个研究点2010年8月23日
相关药物HYALGAN

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
未指定
发起方
FIDIA
状态
进行中(未招募)
最后更新
14年前

概览

简要总结

暂无简介。

注册库
who.int
开始日期
2010年8月23日
结束日期
待定
最后更新
14年前
研究类型
Interventional clinical trial of medicinal product
性别
All

研究者

发起方
FIDIA

入排标准

入选标准

  • \- Aged 18 to 70 years, inclusive; \- Diagnosis of chronic (symptoms persisting for over 6 weeks) or subacute (symptoms persisting for approximately 3\-6 weeks) tendinitis of the Achilles tendon, diagnosed clinically and/or by means of ultrasound; \- Pain in the Achilles tendon at rest or after moderate physical activity; \- Presence of at least one of the following parameters: ? swelling of the tendon, ? increase in local temperature (to the touch), ? pain upon touching or applying pressure, ? limited range of joint motion; \- Total score on VISA\-A less than 60; \- Non responder to traditional tendinitis therapy: anti\-inflammatory and/or physical therapy; \- Non\-responder to abstinence from the physical activity causing pain to the Achilles tendon; \- Signing of informed consent.
  • 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
  • F.1\.3 Elderly (\>\=65 years) yes
  • F.1\.3\.1 Number of subjects for this age range

排除标准

  • \- Tendinitis in acute inflammatory phase; \- Lateral instability of the ankle; \- Obesity: BMI \>35 kg/m2; \- Bilateral tendinitis; \- History of diabetes mellitus or any other disease which in the Investigator\`s opinion might influence the experimental data; \- Presence of areas of degeneration in the tendon (tendinosis); \- History of arthritic and/or metabolic disease; \- Suspected (based on clinical judgement or tests) structural lesions of the tendon (previous or current); \- Previous major trauma to the Achilles tendon; \- Previous surgery on the Achilles tendon under evaluation or on the same ankle; \- Oral, parenteral or intra\-articular use of corticosteroids during the three months previous to enrolment in the study; \- Infiltration therapy with hyaluronic acid on the Achilles tendon under evaluation during the three months previous to enrolment in the study; \- Para\-tendinopathy; \- Pregnancy; \- Participation in other clinical trials during the three months previous to enrolment in the study.

结局指标

主要结局

未指定

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