Evaluation of the efficacy and suppression of the hypothalamic-pituitary-adrenal axis resulting in intrabursale single administration of cortisone in patients with calcific tendonitis of the rotator cuff '': randomized, controlled clinical trial

• Conditions: calcific tendonitis of the rotator cuff; MedDRA version: 14.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-000866-40-IT
• Lead Sponsor: ISTITUTO ORTOPEDICO RIZZOLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-13
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified