Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00746889
Recruitment Status : Completed
First Posted : September 4, 2008
Results First Posted : August 25, 2010
Last Update Posted : August 25, 2010
Sponsor:
Information provided by:
University of California, San Diego

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: triamcinolone acetonide Drug: saline Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis: A Randomized Placebo-Controlled Clinical Trial
Study Start Date : March 2004
Actual Primary Completion Date : July 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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)


Other Outcome Measures:
  1. Change in WOMAC Pain Subscale [ Time Frame: baseline to 12 weeks ]
    WOMAC pain subscale range 0-20 (0=best, 20=worst)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00746889


Locations
Layout table for location information
United States, California
University of California San Diego Medical Center
La Jolla, California, United States, 92093
San Diego VA Hospital
La Jolla, California, United States, 92161
Sponsors and Collaborators
University of California, San Diego
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Kenneth Kalunian, University of California San Diego
ClinicalTrials.gov Identifier: NCT00746889    
Other Study ID Numbers: IRB 051420
First Posted: September 4, 2008    Key Record Dates
Results First Posted: August 25, 2010
Last Update Posted: August 25, 2010
Last Verified: September 2008
Keywords provided by University of California, San Diego:
osteoarthritis
knee
corticosteroids
ultrasound
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
 Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action