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Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment

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ClinicalTrials.gov Identifier: NCT01205477
Recruitment Status : Completed
First Posted : September 20, 2010
Last Update Posted : September 20, 2010
Sponsor:
Information provided by:
Universidad Autonoma de Nuevo Leon

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

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Study Type : Interventional  (Clinical Trial)
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 : September 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010


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 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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. VAS satisfaction [ Time Frame: 4 weeks ]
    Visual Analoge Scale for satisfaction

  2. Improvement [ Time Frame: 4 weeks ]
    Percentage of improvement

  3. SAFETY [ Time Frame: 4 weeks ]
    Pain at infiltration site, ecchymosis, bleeding, paresthesias, skin infection, anaphilaxy, vasovagal reaction



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01205477


Locations
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Mexico
Hospital Universitario "José Eleuterio González"
Monterrey, Nuevo León, Mexico, 66024
Sponsors and Collaborators
Universidad Autonoma de Nuevo Leon
Investigators
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Study Director: Mario Alberto Garza Elizondo, MD Universidad Autónoma de Nuevo León

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.

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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
First Posted: September 20, 2010    Key Record Dates
Last Update Posted: September 20, 2010
Last Verified: June 2009
Keywords provided by Universidad Autonoma de Nuevo Leon:
Anserine bursitis
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Lidocaine
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers