Treatment of Calcific Tendinitis of the Rotator Cuff (NCT02419040) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Calcific Tendinitis of the Rotator Cuff
Norway220 participantsStarted 2015-04
Plain-language summary
The purpose of this study is to determine whether the combination of removal of the calcification in calcific tendinitis of the shoulder (supraspinatus and/or infraspinatus tendon) by aspiration with a needle and syringe (barbotage) and a corticosteroid injection is more effective than corticosteroid or sham injection alone.
Who can participate
Age range30 Years – 100 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 30 years or older
✓. 3 months or more of shoulder pain
✓. Moderate to strong pain localized on the top and/or lateral side of the shoulder, exaggerated by activities above shoulder level
✓. Painful arc
✓. Positive Hawkin's test and/or Neer's sign for impingement
✓. Finding of one or more calcifications ≥5 mm in size on a standard anteriorposterior radiograph, localized proximally to the greater tubercle, together with a sonographic finding of one or more calcifications ≥5 mm in size on the short or long axis view, localized in the supraspinatus or infraspinatus tendon
✓. Morphological radiographic appearance of Molé type A, B or C12 (appendix 2) A: Dense, homogeneous with well-defined limits B: Dense, fragmented with well-defined limits C: Heterogeneous with poorly defined limits and sometimes with a punctuate appearance
✓. Ability to understand written and spoken Norwegian (Swedish/English)
Exclusion criteria
✕. Clinical and radiological signs of a recent spontaneous release of the deposit such as a sudden change in size or density of the deposit on ultrasound together with an acute onset of extreme shoulder pain
✕. Clinical signs of shoulder instability, glenohumeral arthritis, AC pathology, inflammatory arthropathy, fibromyalgia, frozen shoulder or cervical radiculopathy
. Sonographic signs for a rotator cuff tear (full thickness or partial thickness) and of a tear or a dislocation of the long head of the biceps tendon
✕. A history of surgical treatment of the relevant shoulder
✕. A subacromial injection with a corticosteroid during the last 3 months before inclusion
✕. Medical contraindications for any of the invasive procedures
✕. One of the following contraindications for the use of Lidocaine 10 mg/ml: Patients with serious hypovolaemia, known cardiac conduction disturbances, epilepsy or porphyrias, patients with known serious dysfunction of the liver or the kidneys.
✕. One of the following contraindications for the use of Triamcinolone 20 mg/ml: Patients with systemic infections unless specific anti-infective therapy is employed, patients with a local infection in the area of application, patients recently vaccinated with live vaccines, patients with known diabetes mellitus, renal or cardiac insufficiency, ulcerating colitis, gastric ulcer, psychosis, idiopathic thrombocytopenic purpura, or ocular herpes simplex.