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 个研究点开始时间: 2010年8月23日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- 性别
- All
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.
研究者
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