Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment

NCT ID: NCT01205477

Last Updated: 2010-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-07-31

Brief Summary

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

Detailed Description

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Conditions

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Bursitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Methylprednisolone

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

Group Type EXPERIMENTAL

EXPERIMENTAL

Intervention Type DRUG

Infiltration of 40 mg of methylprednisolone acetate plus 1 mL of xylocaine and Diclofenac sodium 100 mg PO QD for 10 days

Placebo

Infiltration of 1 mL of xylocaine

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type DRUG

Infiltration of 1 mL of xylocaine and Diclofenac sodium 100 mg PO QD for 10 days

Interventions

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EXPERIMENTAL

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

PLACEBO

Infiltration of 1 mL of xylocaine and Diclofenac sodium 100 mg PO QD for 10 days

Intervention Type DRUG

Other Intervention Names

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DEPOMEDROL

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of anserine bursitis

Exclusion Criteria

* Intraarticular pathology that reflects pain in the medial part of the knee
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Autonoma de Nuevo Leon

OTHER

Sponsor Role lead

Responsible Party

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Departamento de Reumatología, Hospital Universitario "José Eleuterio González" de la Universidad Autónoma de Nuevo León

Principal Investigators

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Mario Alberto Garza Elizondo, MD

Role: STUDY_DIRECTOR

Universidad Autónoma de Nuevo León

Locations

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Hospital Universitario "José Eleuterio González"

Monterrey, Nuevo León, Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type BACKGROUND
PMID: 17043509 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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RE09-009

Identifier Type: -

Identifier Source: org_study_id