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Using Ultrasonography to Predict Clinical Response to Intraarticular Corticosteroids in Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00414427
First received: December 20, 2006
Last updated: July 7, 2010
Last verified: December 2006
History of Changes
  Purpose

The primary purposes of this study are the following:

  1. To evaluate whether the presence of inflammatory knee osteoarthritis as determined by ultrasonography can be used as a clinical predictor of patient response to intra-articular corticosteroids.
  2. To prospectively evaluate clinical responsiveness of intraarticular corticosteroids with the inflammatory phenotype of knee OA using a randomized, placebo controlled clinical design.
  3. To evaluate whether lower extremity strength is improved with intraarticular corticosteroid injection.

The investigators hypothesize that patients with signs of inflammation by ultrasonography such as synovitis and effusion will respond better to intraarticular corticosteroid injection.


Condition Intervention
Knee Osteoarthritis
 Procedure: Intraarticular steroids

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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • To evaluate whether the presence of inflammatory knee osteoarthritis as determined by ultrasonography can be used as a clinical predictor of patient response to intra-articular corticosteroids.
  • To prospectively evaluate clinical responsiveness of intraarticular corticosteroids with the inflammatory phenotype of knee OA using a randomized, placebo controlled clinical design.

Secondary Outcome Measures:
  • To evaluate whether lower extremity strength is improved with intraarticular corticosteroid injection.

Estimated Enrollment: 120
Study Start Date: December 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Detailed Description:

Osteoarthritis (OA) has previously been thought to be a non-inflammatory condition whose pathologic hallmark is destruction of hyaline cartilage. It is now realized that OA results from a complex interplay of multiple factors, including local inflammatory processes. Evidence suggests that synovitis which is the usual presenting sign of inflammatory arthritis is also frequently present in OA.

The presence of inflammation in knee OA may explain why intra-articular (IA) corticosteroid injections have been shown to result in clinically and statistically significant reduction in osteoarthritic knee pain. Randomized controlled trials have shown that treated patients were less likely to have continuing pain and had significantly lower scores on a visual analogue scale (VAS) for pain. However, studies have failed to determine clinical predictors of response to IA steroid injection, including traditional indices of inflammation (heat, fluid, stiffness). One possibility is that local corticosteroids do no act to relieve pain by reducing synovitis. These putative mechanisms have yet to be elucidated. Perhaps a more plausible explanation is that current methods of assessing local inflammation in OA are inadequate.

Recent studies involving ultrasonography (US) demonstrate that US is a valid and reproducible tool for the detection of synovitis in the knee. It has been shown to be more sensitive than clinical examination and is relatively inexpensive and noninvasive.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Both male and female patients are eligible for the study if they are between 40 and 80 years old, have symptomatic knee OA requiring treatment, and have not responded adequately to treatment with acetominophen or NSAIDs.

Exclusion Criteria:

  • Severe OA as defined by radiographic Kellgren and Lawrence Grade IV
  • The patient being wheel-chair bound
  • Previous knee operation on the affected side within the past year or history of total knee arthroplasty (affected side)
  • Any IA steroid or injections in the last 3 months or viscosupplementation in the last 6 months
  • Local sepsis
  • Local skin conditions
  • Serious concomitant medical illness.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414427

Locations
United States, California
Thorton Hospital
La Jolla, California, United States, 92037
La Jolla Veterans Affairs Medical Center
San Diego, California, United States, 92161
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Kenneth Kalunian, M.D. Univeristy of California at San Diego
  More Information

Publications:

Responsible Party: Kenneth Kalunian, M.D., Professor of Medicine, UCSD
ClinicalTrials.gov Identifier: NCT00414427     History of Changes
Other Study ID Numbers: 051420
Study First Received: December 20, 2006
Last Updated: July 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Knee Osteoarthritis
Ultrasonography
Corticosteroids

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013