Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment

Sponsor

Universidad Autonoma de Nuevo Leon (Other)

Overall Status

Completed

CT.gov ID

NCT01205477

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bursitis	Drug: EXPERIMENTAL Drug: PLACEBO	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Phase 2 Double-blinded, Placebo-controlled, Clinical Trial for Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

WOMAC score [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.

Secondary Outcome Measures

VAS satisfaction [4 weeks]
Visual Analoge Scale for satisfaction
Improvement [4 weeks]
Percentage of improvement
SAFETY [4 weeks]
Pain at infiltration site, ecchymosis, bleeding, paresthesias, skin infection, anaphilaxy, vasovagal reaction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of anserine bursitis

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario "José Eleuterio González"	Monterrey	Nuevo León	Mexico	66024

Sponsors and Collaborators

Universidad Autonoma de Nuevo Leon

Investigators

Study Director: Mario Alberto Garza Elizondo, MD, Universidad Autónoma de Nuevo León

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01205477

Other Study ID Numbers:

RE09-009

First Posted:

Sep 20, 2010

Last Update Posted:

Sep 20, 2010

Last Verified:

Jun 1, 2009

Keywords provided by , ,

Anserine bursitis

Additional relevant MeSH terms:

Bursitis

Methylprednisolone Acetate

Study Results

No Results Posted as of Sep 20, 2010