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Phase 4 N=44 Randomized Single-blind Treatment

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

Tendinopathy · Adrenal Insufficiency

Bottom Line

View on ClinicalTrials.gov: NCT01652495 ↗
Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Functional Improvement Measured According to Percentage Change in Constant Score — 99; 95 percentage of improvement Constant score

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
methylprednisolone acetate (Drug); Triamcinolone Acetonide (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Istituto Ortopedico Rizzoli
Primary completion
May 2013

Outcome Measures

OutcomeResultp-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 —

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.

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
View full record on ClinicalTrials.gov →

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.

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