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Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis

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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

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 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


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




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)



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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

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
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
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

Responsible Party: Kenneth Kalunian, University of California San Diego
ClinicalTrials.gov Identifier: NCT00746889     History of Changes
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:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
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