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 sites54 target enrollmentOctober 30, 2013

Overview

No summary available.

Registry

who.int

Start Date

October 30, 2013

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\-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

•\- 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;