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
- Conditions
- Achilles tendinopathy.MedDRA version: 9.1Level: LLTClassification code 10000433
- Registration Number
- EUCTR2010-020513-87-IT
- Lead Sponsor
- FIDIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to evaluate, using the VISA-A questionnaire, the efficacy of hyaluronic acid infiltration therapy in pain and physical activity in patients with subacute or chronic tendinitis of the Achilles tendon.;Secondary Objective: The secondary objectives consist in evaluating the following: - efficacy of the therapy in improving the clinical profile of the disease; - efficacy of the therapy in improving ultrasound results (thickness of tendon, presence of edema, of tendinosis and signs of phlogosis); - efficacy of the therapy in terms of patient satisfaction and medical judgment ; - anti-inflammatory drugs consumption; - local and systemic tolerance of the therapy.;Primary end point(s): The primary endpoint for efficacy evaluation is the assessment of pain and physical activity using the VISA-A questionnaire.
- Secondary Outcome Measures
Name Time Method