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

Study Overview
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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.

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.

Official Title
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Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to a Single Intrabursal Injection of Corticosteroids in Patients With Shoulder Calcific Tendinopathy

Conditions
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Tendinopathy, Adrenal Insufficiency

Intervention / Treatment
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* Drug: methylprednisolone acetate
* Drug: Triamcinolone Acetonide


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: methylprednisolone acetate group<br>Single intrabursal injection of methylprednisolone acetate | Drug: methylprednisolone acetate<br>* Single intrabursal ultrasound guided injection of 40 mg (1 ml) of methylprednisolone acetate<br>* Other names: Depo-medrol;|
| Active Comparator: Triamcinolone acetonide group<br>Single intrabursal injection of Triamcinolone acetonide | Drug: Triamcinolone Acetonide<br>* Single intrabursal ultrasound guided injection of 40 mg (1 ml) of triamcinolone acetonide<br>* Other names: Triamvirgi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Improvement Measured According to Percentage Change in Constant Score | Patients will be evaluated clinically by Constant Score Constant score: range 0 (total shoulder impairment) to 100 (non impaired shoulder). The score is obtained from two subjective (pain and relation between pain and daily-life activities) - and two objective physician-assessed (strength and range of motion) measurements Reference: Constant CR and Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4. | 180 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis | Evaluation of blood cortisol and ACTH, free urinary cortisol, urinary levels of methylprednisolone or triamcinolone (depending on the administered drug) by RIA immunoassay and tandem mass assays Persistent suppression of the HPA axis at the end of the follow up is based on the evidence of ACTH, plasmatic and urinary cortisol levels under reference values | 45 days after treatment | 
| Reduction of Pain Severity Expressed as Percentage Change in VAS Score | VAS score VAS score is a 10 -cm graduated scale with scores ranging from 0 (no pain) to 10 (unbearable pain) self- reported by patients Reference: Langley GB and Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int 1985;5(4):145-148. | 180 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rotatory cuff calcific tendonitis, corticosteroids, US guided percutaneous treatment, methylprednisolone, triamcinolone, hypothalamus pituitary adrenal axis