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Completed

NCT Number: NCT01205477

Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment

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

Completed

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Key information

Conditions

Bursitis Joint Diseases Musculoskeletal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitario "José Eleuterio González"

Monterrey, Nuevo León, 66024, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of anserine bursitis

Exclusion criteria

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

Treatment and study plan

Experimental

Drug

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

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Nuevo Leon

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 20, 2010
Registry last updated
Sep 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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