Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection (TPESP2011-12)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rotatory Cuff Calcific Tendonitis |
Drug: methylprednisolone acetate Drug: Triamcinolone Acetonide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to a Single Intrabursal Injection of Corticosteroids in Patients With Shoulder Calcific Tendinopathy |
- Degree of functional improvement [ Time Frame: 0, 1, 7, 15, 30 and 45 days after treatment ] [ Designated as safety issue: No ]Patients will be evaluated clinically (VAS and Constants scores) and by ultrasonography (residual calcification and bursa thickness)
- Suppression of hypothalamus-pituitary-adrenal axis [ Time Frame: 0, 1,7, 15, 30 and 45 days after treatment ] [ Designated as safety issue: Yes ]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
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | March 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: methylprednisolone acetate group
Single intrabursal injection of methylprednisolone acetate
|
Drug: methylprednisolone acetate
Single intrabursal ultrasound guided injection
Other Name: Depo-medrol
|
|
Active Comparator: Triamcinolone acetonide group
Single intrabursal injection of Triamcinolone acetonide
|
Drug: Triamcinolone Acetonide
Single intrabursal ultrasound guided injection
Other Name: Triamvirgi
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | milva.battaglia, Clinician, Principal Investigator, Department of Radiology, Istituto Ortopedico Rizzoli |
| ClinicalTrials.gov Identifier: | NCT01652495 History of Changes |
| Other Study ID Numbers: | 2012-000866-40 |
| Study First Received: | July 21, 2012 |
| Last Updated: | January 11, 2013 |
| Health Authority: | Italy: The Italian Medicines Agency |
Keywords provided by Istituto Ortopedico Rizzoli:
|
rotatory cuff calcific tendonitis corticosteroids US guided percutaneous treatment |
methylprednisolone triamcinolone hypothalamus pituitary adrenal axis |
Additional relevant MeSH terms:
|
Tendinopathy Calcinosis Muscular Diseases Musculoskeletal Diseases Tendon Injuries Wounds and Injuries Calcium Metabolism Disorders Metabolic Diseases Methylprednisolone acetate Prednisolone acetate Triamcinolone hexacetonide Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone Triamcinolone |
Triamcinolone Acetonide Prednisolone hemisuccinate Prednisolone phosphate Triamcinolone diacetate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on June 13, 2013