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Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01205477
First Posted: September 20, 2010
Last Update Posted: September 20, 2010
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.
Information provided by:
Universidad Autonoma de Nuevo Leon
July 28, 2010
September 20, 2010
September 20, 2010
September 2009
July 2010   (Final data collection date for primary outcome measure)
WOMAC score [ Time Frame: 4 weeks ]

The WOMAC (Westren Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee using 24 parameters. It can be used to monitor the course of the disease or to determine the effectiveness of anti-rheumatic medications.

Pain, Stiffness and Physical functionVisual analogue scale (VAS) may be used ranging from 0 to 10.

Same as current
No Changes Posted
  • VAS satisfaction [ Time Frame: 4 weeks ]
    Visual Analoge Scale for satisfaction
  • Improvement [ Time Frame: 4 weeks ]
    Percentage of improvement
  • SAFETY [ Time Frame: 4 weeks ]
    Pain at infiltration site, ecchymosis, bleeding, paresthesias, skin infection, anaphilaxy, vasovagal reaction
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment
Phase 2 Double-blinded, Placebo-controlled, Clinical Trial for Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment
To investigate the safety and efficacy of methylprednisolone infiltration in anserine bursitis treatment
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bursitis
  • Drug: EXPERIMENTAL
    Infiltration of 40 mg of methylprednisolone acetate plus 1 mL of xylocaine and Diclofenac sodium 100 mg PO QD for 10 days
    Other Name: DEPOMEDROL
  • Drug: PLACEBO
    Infiltration of 1 mL of xylocaine and Diclofenac sodium 100 mg PO QD for 10 days
  • Experimental: Methylprednisolone
    Infiltration of 40 mg of methylprednisolone acetate plus 1 mL of xylocaine
    Intervention: Drug: EXPERIMENTAL
  • Placebo Comparator: Placebo
    Infiltration of 1 mL of xylocaine
    Intervention: Drug: PLACEBO

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
July 2010
July 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of anserine bursitis

Exclusion Criteria:

  • Intraarticular pathology that reflects pain in the medial part of the knee
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT01205477
RE09-009
Yes
Not Provided
Not Provided
David Vega Morales, Departamento de Reumatología, Hospital Universitario "José Eleuterio González" de la Universidad Autónoma de Nuevo León
Universidad Autonoma de Nuevo Leon
Not Provided
Study Director: Mario Alberto Garza Elizondo, MD Universidad Autónoma de Nuevo León
Universidad Autonoma de Nuevo Leon
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP