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Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection (TPESP2011-12)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01652495
Recruitment Status : Completed
First Posted : July 30, 2012
Results First Posted : September 1, 2014
Last Update Posted : September 1, 2014
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions: Tendinopathy
Adrenal Insufficiency
Interventions: Drug: methylprednisolone acetate
Drug: Triamcinolone Acetonide

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Methylprednisolone Acetate Group

Single intrabursal injection of methylprednisolone acetate

methylprednisolone acetate: Single intrabursal ultrasound guided injection

Triamcinolone Acetonide Group

Single intrabursal injection of Triamcinolone acetonide

Triamcinolone Acetonide: Single intrabursal ultrasound guided injection

Participant Flow:   Overall Study
    Methylprednisolone Acetate Group   Triamcinolone Acetonide Group
STARTED   22   22 
COMPLETED   20   20 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Methylprednisolone Acetate Single intrabursal injection of 40 mg (1 ml) of methylprednisolone acetate
Triamcinolone Acetonide Single intrabursal injection of 40 mg (1 ml) of trimacinolone acetonide
Total Total of all reporting groups

Baseline Measures
   Methylprednisolone Acetate   Triamcinolone Acetonide   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   40 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   20   20   40 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 51.05  (6.67)   46.35  (7.27)   48.70  (7.29) 
[Units: Participants]
Female   14   8   22 
Male   6   12   18 
Region of Enrollment 
[Units: Participants]
Italy   20   20   40 

  Outcome Measures

1.  Primary:   Functional Improvement Measured According to Percentage Change in Constant Score   [ Time Frame: 180 days after treatment ]

2.  Secondary:   Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis   [ Time Frame: 45 days after treatment ]

3.  Secondary:   Reduction of Pain Severity Expressed as Percentage Change in VAS Score   [ Time Frame: 180 days after treatment ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Milva Battaglia, Director of Clinical Trials
Organization: Istituto Ortopedico Rizzoli
phone: 0516366026 ext 0039
e-mail: milva.battaglia@ior.it


Responsible Party: milva.battaglia, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT01652495     History of Changes
Other Study ID Numbers: 2012-000866-40
First Submitted: July 21, 2012
First Posted: July 30, 2012
Results First Submitted: March 22, 2014
Results First Posted: September 1, 2014
Last Update Posted: September 1, 2014