Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment

Bursitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01205477
• Other study ID #: RE09-009
• Status: Completed
• Phase: Phase 2
• First received: July 28, 2010
• Last updated: September 17, 2010
• Start date: September 2009
• Est. completion date: July 2010

Study information

• Verified date: June 2009
• Source: Universidad Autonoma de Nuevo Leon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of anserine bursitis

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bursitis

Intervention

Drug:
• EXPERIMENTAL
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 and Diclofenac sodium 100 mg PO QD for 10 days

Locations

Country	Name	City	State
Mexico	Hospital Universitario "José Eleuterio González"	Monterrey	Nuevo León

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Nuevo Leon

Country where clinical trial is conducted

Mexico, 

References & Publications (2)

Alvarez-Nemegyei J, Canoso JJ. Evidence-Based Soft Tissue Rheumatology IV: Anserine Bursitis. J Clin Rheumatol. 2004 Aug;10(4):205-6. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	VAS satisfaction	Visual Analoge Scale for satisfaction	4 weeks	No
Secondary	Improvement	Percentage of improvement	4 weeks	No
Secondary	SAFETY	Pain at infiltration site, ecchymosis, bleeding, paresthesias, skin infection, anaphilaxy, vasovagal reaction	4 weeks	Yes