Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment

September 17, 2010 updated by: Universidad Autonoma de Nuevo Leon

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 66024
        • Hospital Universitario "José Eleuterio González"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of anserine bursitis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methylprednisolone
Infiltration of 40 mg of methylprednisolone acetate plus 1 mL of xylocaine
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 Names:
  • DEPOMEDROL
Placebo Comparator: Placebo
Infiltration of 1 mL of xylocaine
Drug: PLACEBO
Infiltration of 1 mL of xylocaine and Diclofenac sodium 100 mg PO QD for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS satisfaction
Time Frame: 4 weeks
Visual Analoge Scale for satisfaction
4 weeks
Improvement
Time Frame: 4 weeks
Percentage of improvement
4 weeks
SAFETY
Time Frame: 4 weeks
Pain at infiltration site, ecchymosis, bleeding, paresthesias, skin infection, anaphilaxy, vasovagal reaction
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Nuevo Leon

Investigators

  • Study Director: Mario Alberto Garza Elizondo, MD, Universidad Autonoma de Nuevo Leon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

July 28, 2010

First Submitted That Met QC Criteria

September 17, 2010

First Posted (Estimate)

September 20, 2010

Study Record Updates

Last Update Posted (Estimate)

September 20, 2010

Last Update Submitted That Met QC Criteria

September 17, 2010

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RE09-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe