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Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment

This study has been completed.
Sponsor:
Information provided by:
Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier:
NCT01205477
First received: July 28, 2010
Last updated: September 17, 2010
Last verified: June 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Bursitis
 Drug: EXPERIMENTAL
Drug: PLACEBO
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Bursitis
U.S. FDA Resources

Further study details as provided by Universidad Autonoma de Nuevo Leon:

Primary Outcome Measures:
  • WOMAC score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Visual Analoge Scale for satisfaction

  • Improvement [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Percentage of improvement

  • SAFETY [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Pain at infiltration site, ecchymosis, bleeding, paresthesias, skin infection, anaphilaxy, vasovagal reaction


Enrollment: 58
Study Start Date: September 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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
Other Name: PLACEBO

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of anserine bursitis

Exclusion Criteria:

  • Intraarticular pathology that reflects pain in the medial part of the knee
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205477

Locations
Mexico
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
  More Information

Publications:
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.

Responsible Party: David Vega Morales, Departamento de Reumatología, Hospital Universitario "José Eleuterio González" de la Universidad Autónoma de Nuevo León
ClinicalTrials.gov Identifier: NCT01205477     History of Changes
Other Study ID Numbers: RE09-009
Study First Received: July 28, 2010
Last Updated: September 17, 2010
Health Authority: Mexico: Secretaria de Salud

Keywords provided by Universidad Autonoma de Nuevo Leon:
Anserine bursitis

Additional relevant MeSH terms:
Bursitis
Joint Diseases
Musculoskeletal Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013