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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
History of Changes
  Purpose

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 Intervention
Osteoarthritis
 Drug: triamcinolone acetonide
Drug: saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis: A Randomized Placebo-Controlled Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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)


Enrollment: 79
Study Start Date: March 2004
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Kenneth Kalunian, University of California San Diego
ClinicalTrials.gov Identifier: NCT00746889     History of Changes
Other Study ID Numbers: IRB 051420
Study First Received: September 3, 2008
Results First Received: April 5, 2010
Last Updated: July 29, 2010
Health Authority: United States: Institutional Review Board

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
 Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013