Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tendinopathy Adrenal Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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methylprednisolone acetate group

Single intrabursal injection of methylprednisolone acetate

Group Type ACTIVE_COMPARATOR

methylprednisolone acetate

Intervention Type DRUG

Single intrabursal ultrasound guided injection of 40 mg (1 ml) of methylprednisolone acetate

Triamcinolone acetonide group

Single intrabursal injection of Triamcinolone acetonide

Group Type ACTIVE_COMPARATOR

Triamcinolone Acetonide

Intervention Type DRUG

Single intrabursal ultrasound guided injection of 40 mg (1 ml) of triamcinolone acetonide

Interventions

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methylprednisolone acetate

Single intrabursal ultrasound guided injection of 40 mg (1 ml) of methylprednisolone acetate

Intervention Type DRUG

Triamcinolone Acetonide

Single intrabursal ultrasound guided injection of 40 mg (1 ml) of triamcinolone acetonide

Intervention Type DRUG

Other Intervention Names

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Depo-medrol Triamvirgi

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No