Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection
Condition: Tendinopathy; Adrenal Insufficiency
MeSH terms: Tendinopathy; Pituitary Diseases; Adrenal Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): methylprednisolone acetate; Triamcinolone Acetonide
Intervention type(s): Drug; Drug
Intervention description(s): Single intrabursal ultrasound guided injection of 40 mg (1 ml) of methylprednisolone acetate; Single intrabursal ultrasound guided injection of 40 mg (1 ml) of triamcinolone acetonide
Other intervention name(s): Depo-medrol; Triamvirgi
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Prednisolone hemisuccinate; Prednisolone phosphate; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: rotatory cuff calcific tendonitis; corticosteroids; US guided percutaneous treatment; methylprednisolone; triamcinolone; hypothalamus pituitary adrenal axis