Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment

This study has been completed.
Sponsor:
Information provided by:
Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier:
NCT01205477
First received: July 28, 2010
Last updated: September 17, 2010
Last verified: June 2009

July 28, 2010
September 17, 2010
September 2009
July 2010   (final data collection date for primary outcome measure)
WOMAC score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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
Complete list of historical versions of study NCT01205477 on ClinicalTrials.gov Archive Site
  • VAS satisfaction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Visual Analoge Scale for satisfaction
  • Improvement [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Percentage of improvement
  • SAFETY [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
    Other Name: PLACEBO
  • 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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01205477
RE09-009
Yes
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