Phase 4
Completed N=44
Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection
Source: ClinicalTrials.gov NCT01652495 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Functional Improvement Measured According to Percentage Change in Constant Score — 99; 95 percentage of improvement Constant score
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Improvement Measured According to Percentage Change in Constant Score |
99; 95 | — |
| SECONDARY Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis |
0; 15 | — |
| SECONDARY Reduction of Pain Severity Expressed as Percentage Change in VAS Score |
82; 96 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01652495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.