Achilles tendinopathy. MedDRA version: 9.1 Level: LLT Classification code 10000433
Conditions
Interventions
Trade Name: HYALGAN
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Hyaluronic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceuti
Sponsors
FIDIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed