calcific tendonitis of the rotator cuff MedDRA version: 14.1 Level: SOC Classification code 10028395 Term: Musculoskeletal and connective tissue disorders System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: TRIAMVIRGI*INIET 3FL 40MG 1ML
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: farm2
Concentration unit: mg milligram(s)
Concentra
Sponsors
ISTITUTO ORTOPEDICO RIZZOLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients of both sexes, aged between 30-50 years, suffering from painful calcific tendonitis of the shoulder (calcification or mature phase of resorption) confirmed by ultrasound examination. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • enthesitis calcific shoulder • calcific tendinopathy with lesions of the rotator cuff • Septic arthritis or infection of the superficial tissues or periarticular • Disease hematologic or coagulation (liver failure ....) • metabolic diseases (diabetes) • Glaucoma • Organ Transplant • collagenopatiche diseases or systemic inflammatory rheumatic (SLE, RA ..) • previous use of cortisone 2 months prior to TPE • Concomitant therapy with anticoagulants and / or antiplatelet • A history of asthma, allergic rhinitis, allergic conjunctivitis, bronchiectasis, sarcoidosis (erythema nodosum, uveitis ..), cystic fibrosis, COPD, Crohn's, ulcerative colitis • are allergic to cortisone derivatives • Pregnant or lactating • Minors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of clinically significant difference (according to the scale of Constant) for a single injection of cortisone intrabursale post-TPE;;Secondary Objective: A) evaluate the sonographic appearance with clinical improvement; B) assess the prevalence and duration of inhibition of the HPA axis resulting in intrabursale single injection of cortisone (triamcinolone acetonide or methylprednisolone); C) to correlate the plasma levels of corticosteroid (triamcinolone acetonide or methylprednisolone) with indices of adrenal function.;Primary end point(s): Evaluation of clinically significant difference (according to the scale of Constant) for a single injection of cortisone intrabursale post-TPE;;Timepoint(s) of evaluation of this end point: Day 30 post treatment TPE | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A) evaluate the sonographic appearance with clinical improvement; B) assess the prevalence and duration of inhibition of the HPA axis resulting in intrabursale single injection of corticosteroid (triamcinolone acetonide or methylprednisolone); C) to correlate the plasma levels of corticosteroid (triamcinolone acetonide or methylprednisolone) with indices of adrenal function.;Timepoint(s) of evaluation of this end point: Day 45 post treatment TPE | — |
Countries
Italy
Contacts
Public ContactSC Radiologia Diagnostica
Istituto Ortopedico Rizzoli
Outcome results
None listed