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Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment

Primary Purpose

Bursitis

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
EXPERIMENTAL
PLACEBO
Sponsored by
Universidad Autonoma de Nuevo Leon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bursitis focused on measuring Anserine bursitis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of anserine bursitis

Exclusion Criteria:

  • Intraarticular pathology that reflects pain in the medial part of the knee

Sites / Locations

  • Hospital Universitario "José Eleuterio González"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methylprednisolone

Placebo

Arm Description

Infiltration of 40 mg of methylprednisolone acetate plus 1 mL of xylocaine

Infiltration of 1 mL of xylocaine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

VAS satisfaction
Visual Analoge Scale for satisfaction
Improvement
Percentage of improvement
SAFETY
Pain at infiltration site, ecchymosis, bleeding, paresthesias, skin infection, anaphilaxy, vasovagal reaction

Full Information

First Posted
July 28, 2010
Last Updated
September 17, 2010
Sponsor
Universidad Autonoma de Nuevo Leon
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1. Study Identification

Unique Protocol Identification Number
NCT01205477
Brief Title
Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment
Official Title
Phase 2 Double-blinded, Placebo-controlled, Clinical Trial for Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universidad Autonoma de Nuevo Leon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To investigate the safety and efficacy of methylprednisolone infiltration in anserine bursitis treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bursitis
Keywords
Anserine bursitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylprednisolone
Arm Type
Experimental
Arm Description
Infiltration of 40 mg of methylprednisolone acetate plus 1 mL of xylocaine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Infiltration of 1 mL of xylocaine
Intervention Type
Drug
Intervention Name(s)
EXPERIMENTAL
Other Intervention Name(s)
DEPOMEDROL
Intervention Description
Infiltration of 40 mg of methylprednisolone acetate plus 1 mL of xylocaine and Diclofenac sodium 100 mg PO QD for 10 days
Intervention Type
Drug
Intervention Name(s)
PLACEBO
Intervention Description
Infiltration of 1 mL of xylocaine and Diclofenac sodium 100 mg PO QD for 10 days
Primary Outcome Measure Information:
Title
WOMAC score
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
VAS satisfaction
Description
Visual Analoge Scale for satisfaction
Time Frame
4 weeks
Title
Improvement
Description
Percentage of improvement
Time Frame
4 weeks
Title
SAFETY
Description
Pain at infiltration site, ecchymosis, bleeding, paresthesias, skin infection, anaphilaxy, vasovagal reaction
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of anserine bursitis Exclusion Criteria: Intraarticular pathology that reflects pain in the medial part of the knee
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Alberto Garza Elizondo, MD
Organizational Affiliation
Universidad Autónoma de Nuevo León
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario "José Eleuterio González"
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
66024
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
17043509
Citation
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.
Results Reference
background
Citation
Calvo-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.
Results Reference
background

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Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment

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