Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection
This trial is active, not recruiting.
|Condition||rotatory cuff calcific tendonitis|
|Treatments||methylprednisolone acetate, triamcinolone acetonide|
|Sponsor||Istituto Ortopedico Rizzoli|
|Collaborator||Azienda Ospedaliera San Giovanni Battista|
|Start date||March 2012|
|End date||December 2012|
|Trial size||40 participants|
|Trial identifier||NCT01652495, 2012-000866-40|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Degree of functional improvement
time frame: 0, 1, 7, 15, 30 and 45 days after treatment
Suppression of hypothalamus-pituitary-adrenal axis
time frame: 0, 1,7, 15, 30 and 45 days after treatment
Male or female participants from 18 years up to 70 years old.
Inclusion Criteria: - painful rotator cuff calcific tendonitis demonstrated by ultrasounds Exclusion Criteria: - pregnancy - use of corticosteroids in the previous 2 months - systemic chronic inflammatory or allergic diseases - allergy to methylprednisolone or triamcinolone - diabetes - glaucoma - coagulopathies or current treatment with antiaggregants or anticoagulants - septic arthritis or infections - calcific enthesopathy
|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|
|Description||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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