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

Phase 4

Completed

• Conditions: Adrenal Insufficiency; Tendinopathy
• Interventions: Drug: methylprednisolone acetate; Drug: Triamcinolone Acetonide

• Registration Number: NCT01652495
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief 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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-07-21
• Study First Submitted QC: 2012-07-27
• Study First Posted: 2012-07-30
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2014-03-22
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-23
• Last Update Submitted: 2014-08-23
• Results First Posted: 2014-09-01
• Last Update Posted: 2014-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
methylprednisolone acetate group	methylprednisolone acetate	Single intrabursal injection of methylprednisolone acetate
Triamcinolone acetonide group	Triamcinolone Acetonide	Single intrabursal injection of Triamcinolone acetonide

Primary Outcome Measures

Name	Time	Method
Functional Improvement Measured According to Percentage Change in Constant Score	180 days after treatment	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.

Secondary Outcome Measures

Name	Time	Method
Reduction of Pain Severity Expressed as Percentage Change in VAS Score	180 days after treatment	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.
Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis	45 days after treatment	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

Trial Locations

Locations (1)

Rizzoli Orthopaedic Institute; 🇮🇹 Bologna, Italy