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
1 other identifier
interventional
58
1 country
1
Brief Summary
To investigate the safety and efficacy of methylprednisolone infiltration in anserine bursitis treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 28, 2010
CompletedFirst Posted
Study publicly available on registry
September 20, 2010
CompletedSeptember 20, 2010
June 1, 2009
10 months
July 28, 2010
September 17, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
WOMAC score
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.
4 weeks
Secondary Outcomes (3)
VAS satisfaction
4 weeks
Improvement
4 weeks
SAFETY
4 weeks
Study Arms (2)
Methylprednisolone
EXPERIMENTALInfiltration of 40 mg of methylprednisolone acetate plus 1 mL of xylocaine
Placebo
PLACEBO COMPARATORInfiltration of 1 mL of xylocaine
Interventions
Infiltration of 40 mg of methylprednisolone acetate plus 1 mL of xylocaine and Diclofenac sodium 100 mg PO QD for 10 days
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of anserine bursitis
You may not qualify if:
- Intraarticular pathology that reflects pain in the medial part of the knee
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario "José Eleuterio González"
Monterrey, Nuevo León, 66024, Mexico
Related Publications (2)
Alvarez-Nemegyei J, Canoso JJ. Evidence-Based Soft Tissue Rheumatology IV: Anserine Bursitis. J Clin Rheumatol. 2004 Aug;10(4):205-6. doi: 10.1097/01.rhu.0000135561.41660.b0.
PMID: 17043509BACKGROUNDCalvo-Alén J, Rua-Figueroa I, Erausquin C. Anserine bursitis treatment: local corticoesteroid injction against NSAID: a prospective study [Spanish]. Rev Esp Reumatol. 1993;20:13-15.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mario Alberto Garza Elizondo, MD
Universidad Autónoma de Nuevo León
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 28, 2010
First Posted
September 20, 2010
Study Start
September 1, 2009
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
September 20, 2010
Record last verified: 2009-06