Randomized, controlled, double-blinded clinical trial, with open-label extension on the efficacy of ultrasound guided injection of hyaluronic acid (500-730 KDa) (HYALGAN®) versus saline solution in the conservative treatment of Achilles tendinopathy.

Fidia Farmaceutici SpA0 个研究点目标入组 54 人开始时间: 2013年10月30日最近更新: 2018年2月19日

适应症

试验速览

暂无简介。

•-aged 18 to 70 included
•-diagnosis of chronic (syntoms persisting for over 6 weeks) or subacute (syntoms persisting approximately 3-6 weeks) tendinitis of Achilles tendon, diagnosed clinically or/and by means of ultrasound.
•-presence of at least one of the following parameters:
•- thickening of tendon
•- increased thermotouch,
•- pain to palpation and pressure,
•- VAS = 40 mm
•- Limited range of motion;
•-Total score VISA-A inclusion of less than 60;
•-signing of informed consent form
•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 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 29

•- Tendonitis in acute inflammatory phase (symptoms present for less than 3 weeks);
•- Patients with lateral instability of the ankle;
•- Obese patients with BMI> 35 kg/m2;
•- History of diabetes mellitus or any other disease which, in the opinion of the investigator, would be able to influence the detection of experimental data;
•- History of arthritic diseases and / or metabolic disorders;
•- suspected (based on clinical judgment or tests) structural tendon lacerations (previous or current);
•- serious previous trauma to the Achilles tendon;
•- Patients with bilateral Achilles tendinopathy.
•- Patient undergone previous surgery to the Achilles tendon under study or its ankle;
•- Use of corticosteroids and fluoroquinolones for oral, parenteral or intra-articular in the three months prior to inclusion in the study;
•- injection of hyaluronic acid in the Achilles tendon under evaluation in the three months prior to inclusion in the study;
•- Patient pregnant;
•- Participation in other clinical trials in the three months prior to inclusion in the study.

发起方