Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection (TPESP2011-12)

Istituto Ortopedico Rizzoli

Status and phase: Completed; Phase 4

Conditions: Adrenal Insufficiency; Tendinopathy

Treatments: Drug: Triamcinolone Acetonide; Drug: methylprednisolone acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT01652495

2012-000866-40

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

methylprednisolone acetate group

Active Comparator group

Description:

Single intrabursal injection of methylprednisolone acetate

Treatment:

Drug: methylprednisolone acetate

Triamcinolone acetonide group

Active Comparator group

Description:

Single intrabursal injection of Triamcinolone acetonide

Treatment:

Drug: Triamcinolone Acetonide