Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00746889
First received: September 3, 2008
Last updated: July 29, 2010
Last verified: September 2008

September 3, 2008
July 29, 2010
March 2004
July 2008   (final data collection date for primary outcome measure)
Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale [ Time Frame: baseline to 4 weeks ] [ Designated as safety issue: No ]
WOMAC pain subscale range 0-20 (0=best, 20=worst)
Decrease in pain based on the Western Ontario and McMaster University (WOMAC) osteoarthritis index [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00746889 on ClinicalTrials.gov Archive Site
Not Provided
Improvement in pain as measured by the WOMAC in patients with inflammation on ultrasound at baseline compared to patients without inflammation at baseline [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Osteoarthritis
  • Drug: triamcinolone acetonide
    single intraarticular injection of 40 mg of triamcinolone acetonide
  • Drug: saline
    Single intraarticular injection of 1 ml of 0.9% saline
  • Active Comparator: Corticosteroid Injection
    40 mg of intraarticular triamcinolone acetonide
    Intervention: Drug: triamcinolone acetonide
  • Placebo Comparator: Placebo Injection
    Intraarticular injection of 0.9% saline
    Intervention: Drug: saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
September 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00746889
IRB 051420
No
Kenneth Kalunian, University of California San Diego
University of California, San Diego
Not Provided
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
University of California, San Diego
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP