Tendinopathy Clinical Trial
Official title:
Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to a Single Intrabursal Injection of Corticosteroids in Patients With Shoulder Calcific Tendinopathy
The purpose of this study is to compare the efficacy and effects on the hypothalamus-pituitary-adrenal axis of a single intrabursal injection of two different types of corticosteroids (methylprednisolone and triamcinolone) in patients with calcific shoulder tendinopathy.
Rotator cuff calcific tendonitis is a common disease, mainly affecting women aged 30 to 50
years old. It is associated to severe pain and impotence. US-guided percutaneous treatment
is considered the gold standard treatment with the aim to destroy and wash out shoulder's
calcification, responsible for inflammation, pain and functional limitation. Corticosteroids
are injected in the subacromial-subdeltoid bursa at the end of the procedure to facilitate
the prompt pain relief and functional recovery. Although corticosteroids represent the most
powerful drugs to reduce inflammation and pain, their use is associated to important side
effects, mainly the suppression of the hypothalamus-pituitary-axis (HPA). At the same time,
no standardized protocols exist regarding the best type and dose of corticosteroid to be
injected in association to the above mentioned treatment, nor data evaluating the exact
duration of HPA suppression following a single intrabursal injection of corticosteroids.
40 patients affected by rotator cuff calcific tendonitis will be enrolled in the study and
randomly assigned to two groups: one group (20 patients) will be treated with a single
intrabursal injection of 40 mg of methylprednisolone; the other group (20 patients) will be
treated with a single intrabursal injection of 40 mg of triamcinolone.
All patients will be tested at time 0 (morning before treatment) and at 1, 7, 15, 30 and 45
days after the injection, using clinical, laboratory and US parameters in order to compare
the efficacy and safety of the two drugs.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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