Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis

July 29, 2010 updated by: University of California, San Diego

Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis: A Randomized Placebo-Controlled Clinical Trial

A study using characteristics on ultrasound to predict response to intraarticular steroid injections in patients with knee osteoarthritis. The hypothesis is that patients with inflammation on ultrasound will have a better response to corticosteroid injections compared to patients without inflammation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego Medical Center
      • La Jolla, California, United States, 92161
        • San Diego VA Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • knee pain
  • diagnosis of osteoarthritis in affected knee

Exclusion Criteria:

  • intraarticular corticosteroids in affected knee within past three months
  • primary inflammatory connective tissue disease (ie rheumatoid arthritis)
  • currently taking oral corticosteroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Corticosteroid Injection
40 mg of intraarticular triamcinolone acetonide
Drug: triamcinolone acetonide
single intraarticular injection of 40 mg of triamcinolone acetonide
Placebo Comparator: Placebo Injection
Intraarticular injection of 0.9% saline
Drug: saline
Single intraarticular injection of 1 ml of 0.9% saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale
Time Frame: baseline to 4 weeks
WOMAC pain subscale range 0-20 (0=best, 20=worst)
baseline to 4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in WOMAC Pain Subscale
Time Frame: baseline to 12 weeks
WOMAC pain subscale range 0-20 (0=best, 20=worst)
baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: Kenneth Kalunian, MD, University of California, San Diego
  • Study Chair: Anna Quan, MD, San Diego VA Hospital
  • Study Director: Michal Kalli Hose, MD, San Diego VA Hospital
  • Study Director: Jeannie Chao, MD, University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

September 3, 2008

First Submitted That Met QC Criteria

September 3, 2008

First Posted (Estimate)

September 4, 2008

Study Record Updates

Last Update Posted (Estimate)

August 25, 2010

Last Update Submitted That Met QC Criteria

July 29, 2010

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 051420

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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