Achilles tendinopathy
Conditions
Interventions
Trade Name: Hyalgan
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Infiltration
Sponsors
Fidia Farmaceutici SpA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of this trial is to evaluate, after 28 days from the beginning of therapy, the efficacy of the infiltrative treatment with hyaluronic acid versus saline solution on pain and physical function, using the VISA-A questionnaire, in patients with subacute or chronic tendinitis of Achilles tendon;Secondary Objective: For the double-blinded phase, secondary objectives are: -improvement of clinical disease profile -reduction of pain -improvement of ultrasound results -satisfaction of patient and medical judgment -consumption of anti-inflammatory drugs -local and systemic tolerance of the therapy for the open-label extension, the same objectives will be evaluated, considering the treatment received.;Primary end point(s): Primary endpoint for efficacy is the assessment of pain and physical function using the VISA-A questionnaire.;Timepoint(s) of evaluation of this end point: After 28 days from the first injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: ? Clinical Evaluation: joint movement, ability to walk on their toes and rise up on their toes standing on one foot; ? Ultrasound assessment: the tendon thickness and disappearance of signs of inflammation (edema, flogosis and tendinosis) ? Evaluation of the reduction of pain by VAS ? consumption of Paracetamolo in terms of days of intake; satisfaction of patient and medical judgment;Timepoint(s) of evaluation of this end point: weekly | — |
Countries
Italy
Contacts
Public ContactQualified Person for Pharmacovigila
Fidia Farmaceutici SpA
Outcome results
None listed